In2bones USA, LLC: FDA filings under this applicant name
FDA lists 26 510(k) clearances under 2 spellings of the applicant name “In2bones USA, LLC” (first 2016, latest 2026), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 99 days. Since 2017 the median was 94 days, against 90 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 |
|---|---|---|
| 2016 | 2 | 210 |
| 2017 | 3 | 143 |
| 2018 | 4 | 76 |
| 2019 | 2 | 110 |
| 2020 | 5 | 65 |
| 2021 | 5 | 99 |
| 2022 | 2 | 122 |
| 2023 | 1 | 90 |
| 2024 | 1 | 241 |
| 2025 | 0 | — |
| 2026 | 1 | 52 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name In2bones USA, LLC took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 15 | 15 |
| HWC | Screw, Fixation, Bone | 3 | 3 |
| KWH | Prosthesis, Toe, Constrained, Polymer | 2 | 2 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 2 | 2 |
| HTN | Washer, Bolt Nut | 1 | 1 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 | 1 |
Review panels
- Orthopedic (26)
Most recent In2bones USA, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261154 | CoLink® & CoLag® Non-Sterile Screws | HWC | 2026-05-30 | 52 |
| K233089 | NeoSpan® Compression Implant System | HRS | 2024-05-24 | 241 |
| K231236 | IBS-B MIS Beveled Screw System | HWC | 2023-07-27 | 90 |
| K213698 | CoLink PCR Plating System | HRS | 2022-05-27 | 185 |
| K220260 | Hercules Syndesmosis Implant System | HTN | 2022-03-31 | 59 |
| K212872 | Avenger Radial Head System | KWI | 2021-12-17 | 99 |
| K213069 | CoLink NeoFuse Plating System | HRS | 2021-12-13 | 81 |
| K212487 | CoLink Vallux Plating System | HRS | 2021-11-18 | 101 |
| K203698 | CoLink Sfx Implant System | HTY | 2021-05-04 | 137 |
| K210060 | CoLink Mfx Implant System | HRS | 2021-03-12 | 60 |
16 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 4 recall events; 1 initiated in the last five years. Most recent: 2026-05-11.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- In2bones USA, LLC (25)
- In2Bones USA, LLC (1)
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 Sas (18 510(k)s)
- In2bones USA (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under In2bones USA, LLC?
FDA lists 26 510(k) clearances under 2 spellings of the applicant name “In2bones USA, LLC” (first 2016, latest 2026), across 8 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 USA, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name In2bones USA, LLC is 99 days. Since 2017: 94 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under In2bones USA, LLC?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 15); HWC (Screw, Fixation, Bone, 3); KWH (Prosthesis, Toe, Constrained, Polymer, 2).
Next steps
- See all 26 In2bones USA, LLC clearances with predicates and recalls
- Run predicate analysis for product code HRS, In2bones USA, LLC'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.