# Small Bone Innovations, Inc.

- Location (FDA's records): New York, NY
- FDA decisions: 24 (2005–2013): 24 510(k) clearances
- Names in FDA's records: Small Bone Innovations, Inc. (20); Small Bone Innovations, LLC (4)
- Product codes: HRS (5), HWC (5), JDB (3), KWD (2), KTT (2), HSB (2), JDR (1), HTY (1), JDW (1), KXE (1), KWI (1)
- Predicates its devices cite: 14 (1 its own); citations of its devices by later devices: 32 (1 its own)
- Recalls linked to its devices: 39 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 4 (https://510kreport.com/company/synthes-usa)
- Howmedica Osteonics Corp.: 2 (https://510kreport.com/company/howmedica-osteonics)
- Avanta Orthopaedics, Inc.: 2 (https://510kreport.com/company/avanta-orthopaedics)
- Ferguson Medical: 1 (https://510kreport.com/company/ferguson-medical)
- Stryker Osteonics: 1 (https://510kreport.com/company/stryker-osteonics)
- Ascension Orthopedics, Inc.: 1 (https://510kreport.com/company/ascension-orthopedics)
- Tornier, Inc.: 1 (https://510kreport.com/company/tornier)
- Danek Medical, Inc.: 1 (https://510kreport.com/company/danek-medical)

## Firms that cite its devices most
- In2bones Sas: 3 (https://510kreport.com/company/in2bones)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- Ebi, L.P.: 1 (https://510kreport.com/company/ebi)
- Feet For Life Podiatry Center: 1 (https://510kreport.com/company/feet-for-life-podiatry-center)
- Orthohelix Surgical Designs, Inc.: 1 (https://510kreport.com/company/orthohelix-surgical-designs)
- Synchro Medical: 1 (https://510kreport.com/company/synchro-medical)
- In2bones USA, LLC: 1 (https://510kreport.com/company/in2bones-usa)
- Newclip Technics: 1 (https://510kreport.com/company/newclip-technics)

## Its most-cited devices
- K052576: Sbi Autofix (2005), cited by 10
- K051605: Sbi K-Wires (2005), cited by 6
- K071394: Modification to:Sbi Ringfix (2007), cited by 4
- K093550: Mini Rail External Fixator System (2010), cited by 3
- K071479: Sbi Stafix (2007), cited by 2
- K112982: Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail ) (2012), cited by 2

## Recent decisions
- K130147: Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail) (May 3, 2013)
- K112982: Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail ) (Apr 2, 2012)
- K102180: Rhead Radial Head Extended Stems (Dec 20, 2010)
- K092754: Sbi Foot and Ankle Cannulated Screw System, Model 100-0061 (Jan 19, 2010)
- K093550: Mini Rail External Fixator System (Jan 7, 2010)
- K073635: Sbi SR MTP Toe Implant (Mar 19, 2008)
- K071541: Sbi Twistofix (Sep 10, 2007)
- K063635: Sbi Forefoot Set (Aug 29, 2007)

Source page: https://510kreport.com/company/small-bone-innovations