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The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk.
Altus Spine
Pedicle Screw System, K132280*
- Non-cervical fixation/stabilization device for the treatment of severe spondylolisthesis; immobilization/stabilization an adjunct to fusion to treat acute, chronic instabilities or deformities of the thoracic, lumbar and sacral spine
- Titanium alloy, supplied non-sterile
Anchor Innovation Medical
AIM Suture Anchor, K132461*
- 1.7mm diameter PEEK anchor, pre-mounted on disposable inserter, preloaded with USP size 0 Ultra
- High Molecular Weight Polyethylene suture
- For arthroscopic, mini-open or open surgical procedures for fixation of soft tissue to bone in hand, wrist, foot, ankle
Beijing Libeier Bio-Engineering Institute
Locking Plate, K132642*
- Titanium Locking Plate System for adult patients for fracture fixation in ulna, radius, humerus, femur, tibia, fibula
Binder Biomedical
Logic Standalone Intervertebral Body Fusion Device, K130641
- PEEK spacer with titanium bone screws for intervertebral body fusion
- For use with autogenous bone graft to treat degenerative disc disease at one or two contiguous levels of the lumbosacral spine
Corentec
Lospa IS Pedicle Screw, Straight and Pre-bent Rods, K132644
- For immobilization and stabilization of spinal segments in skeletally mature patients as adjunct to fusion in the treatment of acute and chronic instabilities or deformities; for anterior screw fixation in the treatment of degenerative disc disease
- Titanium; pre-bent rod is additionally available in CoCrMo alloy
Elite Surgical
Biolign Transforaminal Lumbar Interbody Fusion and Anterior Cervical Interbody Fusion Systems, Stand Alone Cervical Cage ACIF, K130274
- TLIF: Slightly curved PEEK Optima cage with tantalum markers, used with supplemental fixation/autograft bone graft, posterolateral insertion
- ACIF: PEEK Optima cage in 2 footprints, various sizes, used with autograft bone
- STACC: Anatomically-shaped PEEK Optima ring, can be packed with autograft, implanted via anterior approach
Innovative Surgical Designs
True Spinal Fixation System, K130958*
- Titanium alloy, pairs of longitudinal rods, polyaxial pedicle screws and rod/rod connectors
- Intended for use only as a dual rod system
- For posterior, non-cervical pedicle fixation to provide immobilization and stabilization as an adjunct to fusion to treat acute and chronic instabilities or deformities
Intelligent Implant
Marauder Cervical-Thoracic Spinal Fixation System, K132900
- Titanium temporary construct intended to stabilize spinal operative site during posterior fusion by means of hooks and screws joined with spinal rods; removed after fusion
Jeil Medical
Arix Foot System, K131311
- Unalloyed Titanium and Titanium Alloy
- Intended for use in internal fixation, reconstruction or arthrodesis of small bones including the fore, mid- and hind foot and ankle
NovoSource
NovoKnee Total Knee, K131398
- Cruciate retaining version of NovoKnee Total Knee
- Has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be “retained” and provide stability to the knee joint
Tyber Medical
Interbody System: ACIF, ALIF, PLIF, TLIF, DLIF, K130573*
- PEEK Optima or PEEK with plasma-sprayed commercially pure titanium coated implants, “toothed” exterior superior and inferior surfaces
- Indicated as intervertebral fusion device in the treatment of degenerative disc disease at one level of cervical spine, placed via anterior approach using autogenous bone
Source: FDA 510(k) Releasable Database, 9/13-10/13; news releases, company web sites
