# In2bones Sas

- Location (FDA's records): Ecully, FR
- FDA decisions: 18 (2014–2024): 18 510(k) clearances
- Product codes: HWC (6), HSN (4), JDR (3), HTY (2), HRS (2), HSB (1)
- 510(k) review time since 2016: median 84 days, against 119 for FDA's reviews in the same codes and years (10 of 14 faster)
- Predicates its devices cite: 59 (7 its own); citations of its devices by later devices: 30 (7 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- New Deal, S.A.: 8 (https://510kreport.com/company/new-deal)
- Memometal Technologies: 4 (https://510kreport.com/company/memometal-technologies)
- Wrightmedicaltechnologyinc: 4 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Small Bone Innovations, Inc.: 3 (https://510kreport.com/company/small-bone-innovations)
- Newdeal Sas: 3 (https://510kreport.com/company/newdeal)
- Synchro Medical: 2 (https://510kreport.com/company/synchro-medical)
- Arthrex, Inc.: 2 (https://510kreport.com/company/arthrex)
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)

## Firms that cite its devices most
- In2bones USA, LLC: 8 (https://510kreport.com/company/in2bones-usa)
- Steps Ortho: 3 (https://510kreport.com/company/steps-ortho)
- OSSIO, Ltd.: 2 (https://510kreport.com/company/ossio)
- Brm Extremities: 1 (https://510kreport.com/company/brm-extremities)
- Synchro Medical: 1 (https://510kreport.com/company/synchro-medical)
- First Ray, LLC: 1 (https://510kreport.com/company/first-ray)
- Avanti Orthopaedics, Inc.: 1 (https://510kreport.com/company/avanti-orthopaedics)
- Lima Corporate S.P.A.: 1 (https://510kreport.com/company/lima-corporate)

## Its most-cited devices
- K153204: In2Bones Kirschner wire (2016), cited by 6
- K131920: Stabilization Screw (2014), cited by 5
- K160174: I.B.S. 2.0 Osteosynthesis screw (2016), cited by 4
- K173121: Ankle Fusion Plating System (2017), cited by 2
- K132912: Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal Implant (2014), cited by 2
- K153770: OS2(R)-VP Varisation Staple (2016), cited by 2

## Recent decisions
- K231699: QUANTUM® Patient Specific Instrumentation (PSI) System (Apr 23, 2024)
- K230313: QUANTUM Patient Specific Instrumentation (PSI) System (Apr 6, 2023)
- K211883: QUANTUM® Patient Specific Instrumentation (PSI) System (Aug 11, 2021)
- K191380: Quantum® Total Ankle Prosthesis (Jan 29, 2020)
- K173811: TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System (Mar 15, 2018)
- K173616: DIP Arthrodesis System (Jan 19, 2018)
- K170688: PIT’Stop® implant (Nov 28, 2017)
- K173121: Ankle Fusion Plating System (Nov 28, 2017)

Source page: https://510kreport.com/company/in2bones