In2bones USA, LLC: FDA clearances and approvals
In2bones USA, LLC has 27 FDA 510(k) clearances (first 2016, latest 2026), across 8 product codes in 1 review panel. Median 510(k) review time: 99 days. Since 2017 its median was 90 days, against 90 days for all cleared 510(k)s in the same product codes. openFDA lists 5 product recalls by a recalling firm named In2bones USA, LLC.
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 | 2 | 166 |
| 2025 | 0 | — |
| 2026 | 1 | 52 |
Review time against the same product codes
Since 2017, In2bones USA, LLC's cleared 510(k)s took a median 90 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 | 16 | 16 |
| 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 (27)
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 |
| K241387 | CoLink NeoFuse MIS Plating System (see attached parts list) | HRS | 2024-08-13 | 90 |
| 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 |
17 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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does In2bones USA, LLC have?
In2bones USA, LLC has 27 FDA 510(k) clearances (first 2016, latest 2026), across 8 product codes in 1 review panel.
How long does FDA take to clear In2bones USA, LLC's 510(k)s?
The median time from FDA receipt to decision across In2bones USA, LLC's cleared 510(k)s is 99 days. Since 2017: 90 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does In2bones USA, LLC make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 16); HWC (Screw, Fixation, Bone, 3); KWH (Prosthesis, Toe, Constrained, Polymer, 2).
Has In2bones USA, LLC had device recalls?
openFDA lists 5 product recalls in 4 recall events by a recalling firm whose name matches In2bones USA, LLC; the most recent began 2026-05-11. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 27 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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.