Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of CONMEDLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list In2Bones with 18 510(k) clearances and 10 device recalls. The most recent is a 510(k) clearance dated Apr 23, 2024: QUANTUM® Patient Specific Instrumentation (PSI) System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 23, 2024 | QUANTUM® Patient Specific Instrumentation (PSI) SystemK231699 · HSN | 510(k) clearances |
| Jan 26, 2024 | I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180Class II · This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws dia | Device recalls |
| Jan 26, 2024 | I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175Class II · This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws dia | Device recalls |
| Apr 6, 2023 | QUANTUM Patient Specific Instrumentation (PSI) SystemK230313 · HSN | 510(k) clearances |
| Aug 11, 2021 | QUANTUM® Patient Specific Instrumentation (PSI) SystemK211883 · HSN | 510(k) clearances |
| Feb 9, 2021 | In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.Class II · This Field Action is being conducted following identification of manufacturing non-conformity of some batches of Shannon | Device recalls |
| Jan 29, 2020 | Quantum® Total Ankle ProsthesisK191380 · HSN | 510(k) clearances |
| Mar 15, 2018 | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemK173811 · HSB | 510(k) clearances |
| Jan 19, 2018 | DIP Arthrodesis SystemK173616 · HTY | 510(k) clearances |
| Nov 28, 2017 | Ankle Fusion Plating SystemK173121 · HRS | 510(k) clearances |
| Nov 28, 2017 | PIT’Stop® implantK170688 · HWC | 510(k) clearances |
| Jul 13, 2017 | Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 (c) DRP 0.27 -Class II · The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking screws when | Device recalls |
| Dec 19, 2016 | SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating SysClass II · Dimensional non-conformity of the thread on the screw head. | Device recalls |
| Dec 19, 2016 | NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating System is intendClass II · Dimensional non-conformity of the thread on the screw head. | Device recalls |
| Dec 19, 2016 | NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticularClass II · Dimensional non-conformity of the thread on the screw head. | Device recalls |
| Nov 18, 2015 | IBS - Osteosynthesis screws for bone fixation Model S25 ST014.Class II · One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
