Here are 30 orthopedic and spine devices to know. Many of them were recently launched or approved by the FDA. The devices are listed in alphabetical order. This list is not an endorsement of these devices.
AperFix II from Cayenne Medical. AperFix II is a recently-launched second generation of the company's soft tissue repair device for multi-ligament knee repairs. AperFix II includes the cannulated tibial system, which is designed to increase the ease of insertion and standardizes the positioning of the implant. The system allows for rotation of the tendons during ACL repair to match the positioning of the native ACL bundles.
AXLE from X-Spine. The AXLE interspinous fusion system recently received FDA clearance. The system is designed to provide spinal stability for lumbar fusion procedures, including treatment for degenerative disc disease, spinal tumors and trauma. The AXLE system includes an implant customized to conform to the patient's anatomy that can be placed through a one-inch incision in the back.
CD HORIZON SOLERA from Medtronic. The CD HORIZON SOLERA spine system was recently released in the United States. The system includes multiple rod material options, choice in rod flexibility and rod strength. The smaller implants can provide the increased room for bone graft required for fusion and reduce impingement on the facet joints.
Epic from Lanx. Epic is an anterior thoracolumbar plating system used during anterior thoracolumbar fusions. The plate was designed for versatility and simplified placement with a single-step cover plate. The system includes lumbar and sacral plate options available in a wide range of sizes. It was recently launched at the AAOS Annual Meeting.
EVOLVE from Wright Medical Group. EVOLVE elbow plating system was recently released to treat fractures of the distal humerus and proximal ulna. The anatomic plating system is composed of polished stainless steel and designed to match the patient's anatomy, which reduces the need for intraoperative bending. The EVOLVE products also include a modular radial head and the radial head plate, which address fractures of the proximal radius.
GRIPTION from DePuy Orthopaedics. The GRIPTION titanium foam implants recently received FDA clearance. The GRIPTION acetabular augmentation system for hip replacement surgery and the GRIPTION cones for knee replacement surgery offer implants made entirely from the proprietary GRIPTION technology. The technology offers a highly porous structure made from pure titanium.
HEALIX TRANSTEND from DePuy Mitek. HEALIX TRANSTEND is an implant system indicated for the repair of partially torn rotator cuffs. The system, launched at the AAOS Annual Meeting, includes new anchors and instrumentation designed to reduce the complexity of partial articular-sided tendon avulsion repair. The system is also designed to reduce the damage surrounding the cuff tissue.
Integra Allograft Cancellous Sponge from Integra LifeSciences. The Integra Allograft Cancellous Sponge, a compressible bone graft composed entirely of cancellous bone, was recently launched. The device can be compressed to half its original size and expand to conform to a variety of spaces for surgical flexibility. The bone graft can be used during spinal fusion or general orthopedic surgeries instead of using bone graft material harvested from the patient's body.
Integrated Spine System from Ortho Development. The Integrated Spine System designed to treat adult degenerative pathologies was recently released. The pedicle screw system includes an external locking cap to eliminate cross threading, a friction head to maintain tulip position, a bone preserving screw thread design and 5.5-mm or 6.0-mm titanium rods.
iTotal CR from ConforMIS. The iTotal CR patient-specific total knee replacement system recently received FDA clearance. The patient-specific process customizes implants for each patient using CT scans from the patient's knee. The image guides the proprietary design and manufacturing of the jigs and personalized implants for the patient.
MATRIX Spine from Synthes. The MATRIX spine system accommodates both open and minimally invasive surgical approaches for deformity, degenerative and trauma indications. The pedicle screw system has a rigid screw-instrument interface and intraoperative adaptability. The system is indicated for use in patients with degenerative disc disease, spondylolisthesis, trauma, deformity, tumor and stenosis, among others.
MDM X3 from Stryker. The MDM X3 modular dual mobility mobile bearing hip system recently received FDA clearance. The device is an addition to the company's portfolio of next-generation technologies designed to minimize risks associated with hip replacement surgery, including both primary and revision total hip arthroplasty patients. The device allows the surgeon to offer Stryker's dual mobility technology to a broader patient population, including those who require advanced fixation.
MOUTAINEER from DePuy Spine. MOUNTAINEER laminoplasty system for posterior decompression of the cervical spine was recently launched. The MOUNTAINEER system is intended for use in the lower cervical and upper thoracic spine to treat spinal stenosis. Notches on the allograft provide secure attachment points, and tabs prevent the holder from migrating into the canal.
MOVEMENT from Ascension Orthopaedics. The company recently expanded the MOVEMENT great toe implant system to include a total arthroplasty component. The completed great toe arthroplasty system allows surgeons the intraoperative choice to perform hemi-resurfacing for either side of the joint or total joint replacement.
NexGen LPS-Flex from Zimmer. NexGen LPS-Flex mobile bearing knee with Prolong highly crosslink polyethylene was recently launched in the United States. The device provides an anteriorly positioned pivot near the end of the ACL to replicate the anatomic center of knee rotation. The Prolong highly crosslinked polyethylene reduces wear and delamination resistance.
OsteoSponge from Bacterin. OsteoSponge is designed for use when replacing a damaged subchondral bone. This FDA approved product is an acellular matrix scaffold made from donated human bone that replaces the patient's damaged bone. The product, which is used during a minimally invasive procedure, is designed to allow the surgeon to incorporate the patient's own stem cells or bioactive agents to accelerate tissue regeneration.
Parallax Contour from ArthroCare. The Parallax Contour is an enhanced vertebral augmentation device that recently received FDA clearance. The device is specifically indicated for void creation in the vertebral body, followed by injection of bone cement. This second-generation device allows surgeons to operate in tight spaces and to provide additional tactile and audible feedback to improve ease of use during the void creation process.
PathFinder NXT from Zimmer. The PathFinder NXT pedicle screw system is designed to increase flexibility for a range of minimally invasive spine procedures. The system facilitates both mini-open and percutaneous approaches. The system is designed to enhance reduction, compression, distraction and bone decortication capabilities. The product was launched at the AAOS Annual Meeting.
PediGuard Curv from SpineGuard. PediGuard Curv was recently introduced among select spine surgeons. The device allows spine surgeons who prefer a curved-tip probe to use the PediGuard technology when placing pedicle screws in the patient's spine. The full launch of the product is expected in April.
Prevision from Aesculap. Aesculap, a B. Braun company, recently received FDA clearance for the Provision Hip System with Recon Ring. The system's temporary distal interlocking strengthens the hold of Prevision and facilitates the return to proximal force transfer following successful bone regeneration.
PRO-TOE VO from Wright Medical Group. PRO-TOE VO hammertoe fixation system was recently launched. The system is indicated for patients requiring the fusion of lesser toes for hammertoe deformity. The system promotes a solid fixation on both sides of the joint and is designed for precise repositioning during surgery.
RECLAIM from DePuy Orthopaedics. RECLAIM revision hip system recently received FDA clearance. The system includes instrumentation that is designed to improve intraoperative handling, flexibility and efficiency. The modularity of the system also allows surgeons several options for treating patient's individual pathology.
rHead from Small Bone Innovations. The rHead recently received FDA clearance for use in correction of complex elbow instabilities and elbow reconstruction. The device is meant for use in conjunction with SBi's Elbow Management System, which incorporates an algorithmic approach for surgeons treating elbow fractures. The rHead Extended Stem increases the treatment options for elbow fractures where fixation may be inadequate.
Short Modular Femoral Hip System from Smith & Nephew. The Short Modular Hip System is a modular total hip replacement stem system designed to exceed the versatility and neck strength of the standard, full sized primary hip implant. This implant is 20 percent shorter than the conventional hip stems and incorporates a bone-conserving design to accommodate for potential future surgeries. The reduced size also means surgeons can make a smaller incision or an anterior incision for the surgery.
Signature Personalized Patient Care System from Biomet. The Signature Personalized Care System for total knee replacements recently received FDA clearance. The system provides patient-matched guides for using total knee replacement surgery paired with Biomet implants. Combined with the MRI or CT images, advanced surgical planning software can tailor the surgery to each specific patient.
SImmetry from Zyga Technology. SImmetry sacroiliac joint fusion system recently received FDA clearance. The system is indicated for treating conditions such as degenerative sacroilitis and sacroiliac joint disruptions. The system includes a range of threaded, cannulated implants and associated instrumentation. The implants are designed to transfix the sacrum and ilium to provide stability for bony fusion.
Spartan 5.5 Needle Anchor from ArthroCare. The Spartan 5.5 Needle Anchor recently received FDA clearance. Spartan is a preloaded threaded anchor indicated for use in fixation of soft tissue to bone. The needle version is used during open repairs. The non-needled version previously received FDA clearance and can be used during arthroscopic repairs. The product is manufactured from PEEK.
TM-S System from Zimmer. The TM-S trabecular metal cervical interbody fusion device recently received FDA clearance. The TM-S system is intended for use with supplemental fixation systems and with autogenous bone graft. It was designed for patients with degenerative disc disease with or without radicular symptoms at one level from C2-T1. The TM-S system is constructed from the company's Trabecular Metal technology, a porous metal biomaterial with structural and mechanical properties similar to cancellous bone.
VisuALIF from SpineSmith. The recently launched, FDA approved VisuALIF device is indicated for use during lumbar intervertebral body fusions. It is the first modular lumbar interbody device with an open face allowing in situ graft placement. The device also offers tactile feedback with face plate attachment and device placement flush with anterior aspect of the vertebrae.
Vitoss BA from Orthovita. Vitoss BA bimodal bone graft substitute recently received FDA clearance. Vitoss is expected to launch in the United States in 9-12 months. The product is a non-structural bone void filler for use in the extremities, pelvis and posterolateral spine. Vitoss BA bimodal differs from the previous versions of Vitoss BA by modifying the size distribution of bioactive glass particles to accelerate the resorption of the bioactive glass.
Read other coverage on orthopedic and spine devices:
- 50 Orthopedic and Spine Devices to Know
- 45 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in January
AperFix II from Cayenne Medical. AperFix II is a recently-launched second generation of the company's soft tissue repair device for multi-ligament knee repairs. AperFix II includes the cannulated tibial system, which is designed to increase the ease of insertion and standardizes the positioning of the implant. The system allows for rotation of the tendons during ACL repair to match the positioning of the native ACL bundles.
AXLE from X-Spine. The AXLE interspinous fusion system recently received FDA clearance. The system is designed to provide spinal stability for lumbar fusion procedures, including treatment for degenerative disc disease, spinal tumors and trauma. The AXLE system includes an implant customized to conform to the patient's anatomy that can be placed through a one-inch incision in the back.
CD HORIZON SOLERA from Medtronic. The CD HORIZON SOLERA spine system was recently released in the United States. The system includes multiple rod material options, choice in rod flexibility and rod strength. The smaller implants can provide the increased room for bone graft required for fusion and reduce impingement on the facet joints.
Epic from Lanx. Epic is an anterior thoracolumbar plating system used during anterior thoracolumbar fusions. The plate was designed for versatility and simplified placement with a single-step cover plate. The system includes lumbar and sacral plate options available in a wide range of sizes. It was recently launched at the AAOS Annual Meeting.
EVOLVE from Wright Medical Group. EVOLVE elbow plating system was recently released to treat fractures of the distal humerus and proximal ulna. The anatomic plating system is composed of polished stainless steel and designed to match the patient's anatomy, which reduces the need for intraoperative bending. The EVOLVE products also include a modular radial head and the radial head plate, which address fractures of the proximal radius.
GRIPTION from DePuy Orthopaedics. The GRIPTION titanium foam implants recently received FDA clearance. The GRIPTION acetabular augmentation system for hip replacement surgery and the GRIPTION cones for knee replacement surgery offer implants made entirely from the proprietary GRIPTION technology. The technology offers a highly porous structure made from pure titanium.
HEALIX TRANSTEND from DePuy Mitek. HEALIX TRANSTEND is an implant system indicated for the repair of partially torn rotator cuffs. The system, launched at the AAOS Annual Meeting, includes new anchors and instrumentation designed to reduce the complexity of partial articular-sided tendon avulsion repair. The system is also designed to reduce the damage surrounding the cuff tissue.
Integra Allograft Cancellous Sponge from Integra LifeSciences. The Integra Allograft Cancellous Sponge, a compressible bone graft composed entirely of cancellous bone, was recently launched. The device can be compressed to half its original size and expand to conform to a variety of spaces for surgical flexibility. The bone graft can be used during spinal fusion or general orthopedic surgeries instead of using bone graft material harvested from the patient's body.
Integrated Spine System from Ortho Development. The Integrated Spine System designed to treat adult degenerative pathologies was recently released. The pedicle screw system includes an external locking cap to eliminate cross threading, a friction head to maintain tulip position, a bone preserving screw thread design and 5.5-mm or 6.0-mm titanium rods.
iTotal CR from ConforMIS. The iTotal CR patient-specific total knee replacement system recently received FDA clearance. The patient-specific process customizes implants for each patient using CT scans from the patient's knee. The image guides the proprietary design and manufacturing of the jigs and personalized implants for the patient.
MATRIX Spine from Synthes. The MATRIX spine system accommodates both open and minimally invasive surgical approaches for deformity, degenerative and trauma indications. The pedicle screw system has a rigid screw-instrument interface and intraoperative adaptability. The system is indicated for use in patients with degenerative disc disease, spondylolisthesis, trauma, deformity, tumor and stenosis, among others.
MDM X3 from Stryker. The MDM X3 modular dual mobility mobile bearing hip system recently received FDA clearance. The device is an addition to the company's portfolio of next-generation technologies designed to minimize risks associated with hip replacement surgery, including both primary and revision total hip arthroplasty patients. The device allows the surgeon to offer Stryker's dual mobility technology to a broader patient population, including those who require advanced fixation.
MOUTAINEER from DePuy Spine. MOUNTAINEER laminoplasty system for posterior decompression of the cervical spine was recently launched. The MOUNTAINEER system is intended for use in the lower cervical and upper thoracic spine to treat spinal stenosis. Notches on the allograft provide secure attachment points, and tabs prevent the holder from migrating into the canal.
MOVEMENT from Ascension Orthopaedics. The company recently expanded the MOVEMENT great toe implant system to include a total arthroplasty component. The completed great toe arthroplasty system allows surgeons the intraoperative choice to perform hemi-resurfacing for either side of the joint or total joint replacement.
NexGen LPS-Flex from Zimmer. NexGen LPS-Flex mobile bearing knee with Prolong highly crosslink polyethylene was recently launched in the United States. The device provides an anteriorly positioned pivot near the end of the ACL to replicate the anatomic center of knee rotation. The Prolong highly crosslinked polyethylene reduces wear and delamination resistance.
OsteoSponge from Bacterin. OsteoSponge is designed for use when replacing a damaged subchondral bone. This FDA approved product is an acellular matrix scaffold made from donated human bone that replaces the patient's damaged bone. The product, which is used during a minimally invasive procedure, is designed to allow the surgeon to incorporate the patient's own stem cells or bioactive agents to accelerate tissue regeneration.
Parallax Contour from ArthroCare. The Parallax Contour is an enhanced vertebral augmentation device that recently received FDA clearance. The device is specifically indicated for void creation in the vertebral body, followed by injection of bone cement. This second-generation device allows surgeons to operate in tight spaces and to provide additional tactile and audible feedback to improve ease of use during the void creation process.
PathFinder NXT from Zimmer. The PathFinder NXT pedicle screw system is designed to increase flexibility for a range of minimally invasive spine procedures. The system facilitates both mini-open and percutaneous approaches. The system is designed to enhance reduction, compression, distraction and bone decortication capabilities. The product was launched at the AAOS Annual Meeting.
PediGuard Curv from SpineGuard. PediGuard Curv was recently introduced among select spine surgeons. The device allows spine surgeons who prefer a curved-tip probe to use the PediGuard technology when placing pedicle screws in the patient's spine. The full launch of the product is expected in April.
Prevision from Aesculap. Aesculap, a B. Braun company, recently received FDA clearance for the Provision Hip System with Recon Ring. The system's temporary distal interlocking strengthens the hold of Prevision and facilitates the return to proximal force transfer following successful bone regeneration.
PRO-TOE VO from Wright Medical Group. PRO-TOE VO hammertoe fixation system was recently launched. The system is indicated for patients requiring the fusion of lesser toes for hammertoe deformity. The system promotes a solid fixation on both sides of the joint and is designed for precise repositioning during surgery.
RECLAIM from DePuy Orthopaedics. RECLAIM revision hip system recently received FDA clearance. The system includes instrumentation that is designed to improve intraoperative handling, flexibility and efficiency. The modularity of the system also allows surgeons several options for treating patient's individual pathology.
rHead from Small Bone Innovations. The rHead recently received FDA clearance for use in correction of complex elbow instabilities and elbow reconstruction. The device is meant for use in conjunction with SBi's Elbow Management System, which incorporates an algorithmic approach for surgeons treating elbow fractures. The rHead Extended Stem increases the treatment options for elbow fractures where fixation may be inadequate.
Short Modular Femoral Hip System from Smith & Nephew. The Short Modular Hip System is a modular total hip replacement stem system designed to exceed the versatility and neck strength of the standard, full sized primary hip implant. This implant is 20 percent shorter than the conventional hip stems and incorporates a bone-conserving design to accommodate for potential future surgeries. The reduced size also means surgeons can make a smaller incision or an anterior incision for the surgery.
Signature Personalized Patient Care System from Biomet. The Signature Personalized Care System for total knee replacements recently received FDA clearance. The system provides patient-matched guides for using total knee replacement surgery paired with Biomet implants. Combined with the MRI or CT images, advanced surgical planning software can tailor the surgery to each specific patient.
SImmetry from Zyga Technology. SImmetry sacroiliac joint fusion system recently received FDA clearance. The system is indicated for treating conditions such as degenerative sacroilitis and sacroiliac joint disruptions. The system includes a range of threaded, cannulated implants and associated instrumentation. The implants are designed to transfix the sacrum and ilium to provide stability for bony fusion.
Spartan 5.5 Needle Anchor from ArthroCare. The Spartan 5.5 Needle Anchor recently received FDA clearance. Spartan is a preloaded threaded anchor indicated for use in fixation of soft tissue to bone. The needle version is used during open repairs. The non-needled version previously received FDA clearance and can be used during arthroscopic repairs. The product is manufactured from PEEK.
TM-S System from Zimmer. The TM-S trabecular metal cervical interbody fusion device recently received FDA clearance. The TM-S system is intended for use with supplemental fixation systems and with autogenous bone graft. It was designed for patients with degenerative disc disease with or without radicular symptoms at one level from C2-T1. The TM-S system is constructed from the company's Trabecular Metal technology, a porous metal biomaterial with structural and mechanical properties similar to cancellous bone.
VisuALIF from SpineSmith. The recently launched, FDA approved VisuALIF device is indicated for use during lumbar intervertebral body fusions. It is the first modular lumbar interbody device with an open face allowing in situ graft placement. The device also offers tactile feedback with face plate attachment and device placement flush with anterior aspect of the vertebrae.
Vitoss BA from Orthovita. Vitoss BA bimodal bone graft substitute recently received FDA clearance. Vitoss is expected to launch in the United States in 9-12 months. The product is a non-structural bone void filler for use in the extremities, pelvis and posterolateral spine. Vitoss BA bimodal differs from the previous versions of Vitoss BA by modifying the size distribution of bioactive glass particles to accelerate the resorption of the bioactive glass.
Read other coverage on orthopedic and spine devices:
- 50 Orthopedic and Spine Devices to Know
- 45 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in January