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Strategic Orthopaedic-related 510(k) Update

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

Titanium Nailing System, K113387*

  • Dinamic T Humerus for proximal humeral fractures, Endovis BA Femur for lateral proximal femoral fractures, etc.

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

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*

  • Start-up 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.”

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
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