In2bones Sas: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “In2bones Sas” (first 2014, latest 2024), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 71 days, against 105 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under CONMED, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 3 | 309 |
| 2015 | 1 | 99 |
| 2016 | 5 | 86 |
| 2017 | 3 | 71 |
| 2018 | 2 | 74 |
| 2019 | 0 | — |
| 2020 | 1 | 251 |
| 2021 | 1 | 51 |
| 2022 | 0 | — |
| 2023 | 1 | 59 |
| 2024 | 1 | 316 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name In2bones Sas took a median 71 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 6 | 6 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 4 | 4 |
| JDR | Staple, Fixation, Bone | 3 | 3 |
| HRS | Plate, Fixation, Bone | 2 | 2 |
| HTY | Pin, Fixation, Smooth | 2 | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
Review panels
- Orthopedic (18)
Most recent In2bones Sas 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231699 | QUANTUM® Patient Specific Instrumentation (PSI) System | HSN | 2024-04-23 | 316 |
| K230313 | QUANTUM Patient Specific Instrumentation (PSI) System | HSN | 2023-04-06 | 59 |
| K211883 | QUANTUM® Patient Specific Instrumentation (PSI) System | HSN | 2021-08-11 | 51 |
| K191380 | Quantum® Total Ankle Prosthesis | HSN | 2020-01-29 | 251 |
| K173811 | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System | HSB | 2018-03-15 | 90 |
| K173616 | DIP Arthrodesis System | HTY | 2018-01-19 | 58 |
| K173121 | Ankle Fusion Plating System | HRS | 2017-11-28 | 60 |
| K170688 | PITStop® implant | HWC | 2017-11-28 | 266 |
| K170594 | I.B.S. osteosynthesis screws | HWC | 2017-05-10 | 71 |
| K160174 | I.B.S. 2.0 Osteosynthesis screw | HWC | 2016-10-06 | 253 |
8 earlier clearances. See the full list in Caduvo.
Recalls
10 product recalls in 6 recall events; 2 initiated in the last five years. Most recent: 2024-01-26.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- In2bones USA, LLC (27 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under In2bones Sas?
FDA lists 18 510(k) clearances under the applicant name “In2bones Sas” (first 2014, latest 2024), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by In2bones Sas?
The median time from FDA receipt to decision across 510(k)s cleared under the name In2bones Sas is 90 days. Since 2017: 71 days, versus 105 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under In2bones Sas?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 6); HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer, 4); JDR (Staple, Fixation, Bone, 3).
Next steps
- See all 18 In2bones Sas clearances with predicates and recalls
- Run predicate analysis for product code HWC, In2bones Sas's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.