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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.
Ascendx Spine
Acu-Cut Vertebral Augmentation System, K113452
- For use with Ascendx Cement, manufactured by TECRES
AtPac Medical
OsteoLaso Bone Void Filler, K111018*
- Granule and strips
- Beta-tricalcium phosphate and polyphosphate
BM Korea
Synster Cervical Cage, K111820
- PEEK-Optima construction
Citieffe
Titanium Nailing System, K113387*
- Dinamic T Humerus for proximal humeral fractures, Endovis BA Femur for lateral proximal femoral fractures, etc.
Corentec
Eaum Total Knee, K110404
- For cemented use only
- Co-Cr-Mo alloy femoral components and tibial baseplate components; UHMWPE tibial insert components and patellar components
- Includes cruciate retaining and posterior stabilized designs
Eisertech
PLIF Cage, K113478
- Lumbar intervertebral fusion device with bone graft
- Company focuses on “product areas that can be adopted by surgeons without having to attend a specialty training course and can be serviced and re-ordered by hospital or surgery center staff without assistance from an on-site company representative.”
EnHatch Orthopaedics
Patient/Technique-specific Humeral Plate, K112663*
- Startup company; management includes notable orthopaedic industry-specific experience
- Company has also designed a “crowd-funding and collaboration platform that empowers medical professionals to hatch good ideas into great products.”
Medicrea
LigaPass, K112736
- Temporary orthopaedic implant intended to provide stabilization during development of solid bony fusion, aid in repair of bone fractures
- Designed to be incorporated into constructs and used in conjunction with other medical implants
NeoOrtho Produtos
NeoFix Small and Large Fragment Osteosynthesis System, K113733
- Titanium, for upper and lower limbs
Ortho Solutions
Extremity Fixation Implants, K111678
- Foot Plating System, Memo Staple System, Foot Osteotomy System, Staples, Compression Screws, TwistFix Snap-Off Screws, Extremity Fixation System
Pipeline Orthopedics
Total Hip System, K112802*
CR Primary Knee System, K113122
- Founded by management team with “more than a century of experience in orthopedics”
- Company created to focus on “design of high tech orthopedic implants, manufactured with novel biomaterials, for use with navigation and robotic bone preparations”
Savannah Technologies
Spinal System, K113755*
- Adaptable titanium alloy fixation system designed to allow dorsal stabilization of the spine
Skeletal Design Partnership
www.skelov8.com
Foundation Spinal System, K120074*
Solana Surgical
Hemi Phalangeal Implant Instrument Set, K113752
- Cobalt Chromium (titanium plasma spray-coated stem) intended to replace articulating surface of phalangeal bone at metatarsaiphalangeal joint
Total Joint Orthopedics
Klassic Knee System, K112906
- Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis for primary knee replacement
- Cobalt Chromium alloy femur, titanium alloy tibial baseplate, UHMWPE patella and tibial inserts, etc.
Sources: FDA 510(k) Releasable Database, 2/12 and 3/12, news releases, company web sites
