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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.

Alphatec Spine
Solus Anterior Lumbar Interbody Fusion System, K123993

  • Clearance relates to design changes
  • In 1Q12, voluntarily recalled deployment instrument for Solus ALIF (from beta launch) to improve performance in surgeries involving extremely hard or sclerotic bone (a problem not dissimilar from other standalone ALIF devices)

Biomecanica Industria e Comerico
SP2 Femoral and Tibial Locking Nails, K123745*

  • Dynamic advanced locking mode enables intra-op fracture compression, increasing rotational and angular stability

Dallen Medical
Compressyn Staple, K122871

  • Stainless steel staple delivered by a pneumatic device
  • Indicated for hand/foot bone fragment and osteotomy fixation, joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, etc.

Facet Screw System, K123497*

  • Titanium alloy system, indicated for facet fixation with or without bone graft, at single or multiple levels from C2 to SI (inclusive)

Flower Orthopedics
Small and Medium Bone Plates, K123562*

  • For internal fixation of fractures and reconstruction of bones
  • May be used for palmar, ventral, dorsal or orthogonal applications

Global Manufacturing Technology
Paragon Hip System, K123782

  • Incorporates tension grooves on lateral aspect of stem to reproduce native physiological bone strain, enhance quality of stem fixation

Kalitec Direct
Intess Lumbar Cage, K123100

  • Zeniva ZA-500 PEEK with tantalum markers
  • For intervertebral body fusion in the treatment of degenerative disc disease

Maxim Surgical
Surgical X-Treme Interbody Fusion System, K123206*

  • PEEK-based cervical interbody fusion system
  • Neutral and lordotic cages in 2 footprints with varying heights designed to accommodate patient anatomy, may be implanted as single device via anterior approach

J-Scope Arthroscope, K122411

  • Single use device indicated for use in the shoulder, hip, wrist, ankle, knee, and elbow joints; can be used under local anesthesia

Orthopaedic Implant Company
Plating Systems, K123832

  • Distal Radius, Proximal Humerus, Clavicle, Small Fragment, etc.

Ankle Trauma System, K122936

  • Titanium plates internal fixation of long bones, bone fragments
  • Particularly in osteopenic bone, the system is intended for fixation of complex intra- and extraarticular fractures and osteotomnies of the distal tibia and other small bones

Renovis Surgical
A200 Knee System, K120038

  • Total knee for cemented use
  • Components manufactured from Co-Cr-Mo, titanium, ultra-high molecular weight polyethylene with and without vitamin E

Spectrum Spine
Laminoplasty Plating System, K122822*

  • Intended for use in the lower cervical and upper thoracic spine (C3-T3) following laminoplasty

Silex Sacroiliac Joint Fusion System, K123702

  • Titanium alloy system for fixation of large bones (including pelvis) for conditions including degenerative sacroiliitis and sacroiliac joint disruptions

Sources: FDA 510(k) Releasable Database, 2/13-3/13; news release; company web sites