Small Bone Innovations, Inc.
United StatesFDA applicant, unverified
- Devices
- 24
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Small Bone Innovations, Inc. makes
Small Bone Innovations, Inc. manufactures orthopedic fixation devices for foot, ankle, wrist, and elbow surgeries, including external fixators, interlocking nails for ankle arthrodesis, toe implants, and specialized plates for carpal fusion. Their portfolio also includes radial head implants with extended stems, ulnar head implants, and modular systems for lateral radio-capitellum stabilization.
The company’s devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) database, reflecting compliance with US medical device regulations. The manufacturer is based in the United States.
Catalogue
Search and filter all 24 devicesFDA recalls
FDA recall records list 3 recalls initiated by Small Bone Innovations, Inc., the earliest on 2013-09-06 and the most recent on 2014-05-19. By recorded status: 3 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2014
- 19 May 2014 Z-2127-2014 Class II Terminated Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments to update the IFU.
- 7 Apr 2014 Z-1720-2014 Class II Terminated Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires labeled as item #451-3004 Drill tip 1.8 mm diameter 400mm olive k-wire packaged with item #451-3005 Bayonet tip 1.8mm diameter 400mm olive k-wire inside.
2013
- 6 Sep 2013 Z-0098-2014 Class II Terminated The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.
Frequently asked questions
How many devices does Small Bone Innovations, Inc. have in the registry?
The registry currently lists 24 devices for Small Bone Innovations, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Small Bone Innovations, Inc.'s devices?
Among its 24 most recently registered devices, Small Bone Innovations, Inc. has devices listed in FDA 510(k) (24 devices).
What risk classes do Small Bone Innovations, Inc.'s devices fall under?
Among its 24 most recently registered devices, the classes recorded for Small Bone Innovations, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Small Bone Innovations, Inc.?
FDA recall records list 3 recalls initiated by Small Bone Innovations, Inc., the most recent initiated on 19 May 2014. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Small Bone Innovations, Inc. in the registry?
The most recently registered devices listed for Small Bone Innovations, Inc. include MINI RAIL EXTERNAL FIXATOR SYSTEM, SBI FOREFOOT SET, ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL ) and SBI K-WIRES.