Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pega Medical, Inc. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
228 daysmedian FDA review time
273 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220190 | The GIRO Growth Modulation System | Pega Medical, Inc. | 2022-10-24 | 273 | 0 |
| K211292 | Fassier-Duval Telescopic IM System | Pega Medical, Inc. | 2021-05-26 | 28 | 0 |
| K192710 | The Simple Locking Intramedullary (Slim) System | Pega Medical, Inc. | 2020-06-24 | 271 | 0 |
| K170704 | The Locking Pediatric Osteotomy Plate (LolliPOP) System | Pega Medical, Inc. | 2017-09-08 | 184 | 0 |
| K163003 | Y3 Proximal Femoral Plate System | Pega Medical, Inc. | 2017-03-16 | 139 | 0 |
| K160545 | GAP ENDO-EXO MEDULLARY SYSTEM | Pega Medical, Inc. | 2016-11-23 | 271 | 0 |
| K143355 | The Simple Locking IntraMedullary (SLIM) System | Pega Medical, Inc. | 2015-07-10 | 228 | 0 |
| K131591 | FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) | Pega Medical, Inc. | 2013-11-27 | 180 | 2 |
| K111232 | GAP ENDO-EXO MEDULLARY SYSTEM | Pega Medical, Inc. | 2012-01-26 | 269 | 1 |
| K090440 | HINGE PEDIATRIC PLATING SYSTEM | Pega Medical, Inc. | 2009-05-20 | 89 | 0 |
| K041393 | FASSIER-DUVAL TELSCOPIC IM SYSTEM | Pega Medical, Inc. | 2004-08-17 | 85 | 5 |
| K020885 | FASSIRE-DUVAL TELESCOPIC IM SYSTEM | Pega Medical, Inc. | 2003-02-06 | 325 | 4 |
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