Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
In2bones Sas — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
316 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231699 | QUANTUM® Patient Specific Instrumentation (PSI) System | In2bones Sas | 2024-04-23 | 316 | 0 |
| K230313 | QUANTUM Patient Specific Instrumentation (PSI) System | In2bones Sas | 2023-04-06 | 59 | 0 |
| K211883 | QUANTUM® Patient Specific Instrumentation (PSI) System | In2bones Sas | 2021-08-11 | 51 | 0 |
| K191380 | Quantum® Total Ankle Prosthesis | In2bones Sas | 2020-01-29 | 251 | 0 |
| K173811 | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System | In2bones Sas | 2018-03-15 | 90 | 0 |
| K173616 | DIP Arthrodesis System | In2bones Sas | 2018-01-19 | 58 | 0 |
| K170688 | PIT’Stop® implant | In2bones Sas | 2017-11-28 | 266 | 0 |
| K173121 | Ankle Fusion Plating System | In2bones Sas | 2017-11-28 | 60 | 0 |
| K170594 | I.B.S. osteosynthesis screws | In2bones Sas | 2017-05-10 | 71 | 0 |
| K160174 | I.B.S. 2.0 Osteosynthesis screw | In2bones Sas | 2016-10-06 | 253 | 0 |
| K160995 | NEOVIEW Plating System | In2bones Sas | 2016-06-10 | 63 | 3 |
| K153770 | OS2(R)-VP Varisation Staple | In2bones Sas | 2016-03-21 | 82 | 0 |
| K153395 | OS2-C Compression Staple | In2bones Sas | 2016-02-18 | 86 | 0 |
| K153204 | In2Bones Kirschner wire | In2bones Sas | 2016-02-01 | 89 | 0 |
| K143323 | OS2-V Varisation Staple | In2bones Sas | 2015-02-26 | 99 | 0 |
| K132912 | DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL I | In2bones Sas | 2014-07-30 | 316 | 2 |
| K131920 | STABILIZATION SCREW | In2bones Sas | 2014-05-01 | 309 | 3 |
| K132911 | I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW | In2bones Sas | 2014-04-04 | 199 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda