Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
The Orthopaedic Implant Company · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
313 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242995 | OIC Small / Mini Fragment Plate System | The Orthopaedic Implant Company | 2024-10-23 | 27 | 0 |
| K182736 | OIC Suture Anchor System | The Orthopaedic Implant Company | 2018-12-28 | 91 | 0 |
| K181184 | OIC Intramedullary Nail System | The Orthopaedic Implant Company | 2018-07-27 | 85 | 0 |
| K160222 | OIC Cervical PEEK Spacer | The Orthopaedic Implant Company | 2016-12-07 | 313 | 0 |
| K113123 | OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYS | The Orthopaedic Implant Company | 2012-01-12 | 83 | 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