Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
In2Bones USA, LLC — Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
185 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261154 | CoLink® & CoLag® Non-Sterile Screws | In2Bones USA, LLC | 2026-05-30 | 52 | 0 |
| K233089 | NeoSpan® Compression Implant System | In2bones USA, LLC | 2024-05-24 | 241 | 0 |
| K231236 | IBS-B MIS Beveled Screw System | In2bones USA, LLC | 2023-07-27 | 90 | 0 |
| K213698 | CoLink PCR Plating System | In2bones USA, LLC | 2022-05-27 | 185 | 0 |
| K220260 | Hercules Syndesmosis Implant System | In2bones USA, LLC | 2022-03-31 | 59 | 0 |
| K212872 | Avenger Radial Head System | In2bones USA, LLC | 2021-12-17 | 99 | 0 |
| K213069 | CoLink NeoFuse Plating System | In2bones USA, LLC | 2021-12-13 | 81 | 0 |
| K212487 | CoLink Vallux Plating System | In2bones USA, LLC | 2021-11-18 | 101 | 0 |
| K203698 | CoLink Sfx Implant System | In2bones USA, LLC | 2021-05-04 | 137 | 0 |
| K210060 | CoLink Mfx Implant System | In2bones USA, LLC | 2021-03-12 | 60 | 0 |
| K201636 | Hercules Suture Anchor System | In2bones USA, LLC | 2020-08-20 | 65 | 0 |
| K201149 | CoLink Plating System | In2bones USA, LLC | 2020-07-15 | 77 | 0 |
| K200762 | CoLink Cfx Plating System | In2bones USA, LLC | 2020-04-23 | 30 | 0 |
| K193543 | CoLink Plating System, Fracture and Correction System, CoLin | In2bones USA, LLC | 2020-01-17 | 28 | 0 |
| K192754 | Avenger Radial Head System | In2bones USA, LLC | 2020-01-07 | 99 | 0 |
| K190385 | CoLink Plating System, Fracture and Correction System, RTS I | In2bones USA, LLC | 2019-08-08 | 170 | 0 |
| K191535 | CoLink® Mini Plating System | In2bones USA, LLC | 2019-07-29 | 49 | 0 |
| K182402 | CoLink View Plating System | In2bones USA, LLC | 2018-09-27 | 23 | 0 |
| K180377 | Fracture and Correction System | In2bones USA, LLC | 2018-06-20 | 128 | 0 |
| K181113 | CoLink™ Afx Plating System | In2bones USA, LLC | 2018-06-15 | 49 | 0 |
| K173491 | RTS Lesser MTP Implant System | In2bones USA, LLC | 2018-02-23 | 102 | 0 |
| K172300 | CoLink View Plating System | In2bones USA, LLC | 2017-11-27 | 119 | 0 |
| K170518 | In2Bones Fracture and Correction System | In2bones USA, LLC | 2017-07-14 | 143 | 0 |
| K163293 | Colink™ Plating System | In2bones USA, LLC | 2017-05-05 | 164 | 0 |
| K161426 | NeoSpan Compression Staple Impant w/instruments | In2bones USA, LLC | 2016-10-24 | 154 | 1 |
| K153609 | RTS Flexible 1 MPJ Implant w/Grommets | In2bones USA, LLC | 2016-09-08 | 266 | 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