Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Limacorporate — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243809 | Biolox® Delta Revision heads | Limacorporate | 2025-03-04 | 83 | 0 |
| K213785 | SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid | Limacorporate | 2022-05-13 | 158 | 0 |
| K211938 | Physica LMC Knee System | Limacorporate | 2021-07-13 | 20 | 0 |
| K190911 | Physica KR Liner and SMR Reverse Humeral Liner | Limacorporate | 2019-11-26 | 232 | 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