FDA applicant

In2bones Sas

Ecully, FR18 decisions2014–20249 recalls

FDA records 18 decisions for In2bones Sas (Ecully, FR) from 2014 to 2024: 18 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HSN (Prosthesis, Ankle, Semi-Constrained, Cemented…). Since 2016 its 510(k)s took a median of 84 days from receipt to decision, against 119 for FDA’s reviews in the same codes and years. Its devices cite 59 predicates, 7 of them its own earlier devices. 9 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided In2bones Sas’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2014high 5 (2016) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

2in 2024

2014high 3 (2015) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — In2bones Sas by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like In2bones Sas’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

HWCScrew, Fixation, Bone6decisions
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer4decisions
JDRStaple, Fixation, Bone3decisions
HTYPin, Fixation, Smooth2decisions
HRSPlate, Fixation, Bone2decisions
HSBRod, Fixation, Intramedullary And Accessories1decision

How long do its 510(k) reviews take?

Since 2016, its 14 510(k)s took a median of 84 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 119 days; 10 of its 14 were faster than that.

Whose devices does it build on?

Its devices cite 59 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 30 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

K153204In2Bones Kirschner wireIn2bones Sas · 20166cite it
K131920Stabilization ScrewIn2bones Sas · 20145cite it
K160174I.B.S. 2.0 Osteosynthesis screwIn2bones Sas · 20164cite it
K173121Ankle Fusion Plating SystemIn2bones Sas · 20172cite it
K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas · 20142cite it
K153770OS2(R)-VP Varisation StapleIn2bones Sas · 20162cite it

What has FDA decided for it lately?

K231699QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones Sas · 2024
K230313QUANTUM Patient Specific Instrumentation (PSI) SystemIn2bones Sas · 2023
K211883QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones Sas · 2021
K191380Quantum® Total Ankle ProsthesisIn2bones Sas · 2020
K173811TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemIn2bones Sas · 2018
K173616DIP Arthrodesis SystemIn2bones Sas · 2018
K170688PIT’Stop® implantIn2bones Sas · 2017
K173121Ankle Fusion Plating SystemIn2bones Sas · 2017

All 18 as In2bones Sas →

What has been recalled?

9 recalls linked to its devices; the latest:

K131920I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180Jan 26, 2024Class II
K131920I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175Jan 26, 2024Class II
K160995Non-Locking screws in the following lengths: (a) NEO (R) 0.27 - 10 mm, REF W27 ST010 (b)…Jul 13, 2017Class II
K160995NEOVIEW (R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW Plating System is intended…Dec 19, 2016Class II
K160995SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit…Dec 19, 2016Class II
K160995NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130…Dec 19, 2016Class II

Other applicant names beginning “In2bones”

FDA records each applicant name separately; these may or may not be the same firm.

In2bones USA, LLC 27