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.

Accel Spine
Matisse Anterior Cervical Interbody Fusion Cage, K121569*
• PEEK-OPTIMA-LTl with marker pins made of Tantalum (ASTM F 560)
• For use with bone cement

Picasso MIS Spinal Fixation System, K120714
• Cannulated polyaxial screw, straight and curved rod, crosslink and set screw; can be used via percutaneous approach

Renoir Posterior Cervical Fixation, K121136
• Titanium alloy, top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system with polyaxial screws, semi-reduction poly screws, reduction poly screws, straight rods, curved rods, set screws, etc.

Altomec Endoscopy
Rigid Arthroscope, K112548*
• Company launched in 2001 offering scope repair services

Clariance
Erisma-LP Non-cervical Pedicle Fixation System, K120469*
• Adjunct to fusion for treatment of degenerative disc disease, spondylolisthesis, fracture, scoliosis, etc.

Ingen Orthopedics
Seviin Reverse Shoulder, K120374*
• Ti-6A1-4V alloy metaglene plate with titanium plasma spray coating, Ti-6A1-4V alloy bone screws, Co-Cr-Mo alloy glenosphere, Co-Cr-Mo alloy humeral cup and ultra-high molecular weight polyethylene (UHMWPE) inlay
• Components intended for use with humeral stems previously cleared as Genesis humeral stems

Implanet
Calypso Spinal Fixation System, K120564*
• Ti6AI4V titanium alloy, for posterior, non-cervical pedicle and non-pedicle fixation
• Indicated for treatment of degenerative disc disease, spondylolisthesis, trauma, deformities, etc.

Lima
SMR Resurfacing Shoulder, K112900
• CoCrMo heads, plasma spray titanium coated inner surface, Ti6AI4V stems, ultra-high molecular weight polyethylene glenoid
• Standard or CTA heads
• Humeral heads/stems for uncemented use only; glenoid components for cemented use only

MAKO Surgical
MAKOplasty Total Hip Application, K121064
• Upgrade to RIO-THA to improve overall performance of system in supporting total hip arthroplasty
• Includes optical detector, robotic arm and guidance module for use with pre-operative planning laptop, reusable and disposable instrumentation

NeuroVention
LamiFix Laminoplasty Plating System, K121276*
• Titanium alloy pre-bent miniplates designed to fit anatomy of the vertebral arch, to hold allograft in place following laminoplasty

Nexxt Spine
Honour Spacer, K120345
• PEEK-based radiolucent cages for use in cervical and lumbar intervertebral fusion, vertebral body replacement

Sources: FDA 510k Releasable Database, 6/12-8/12; news releases; company web sites