Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
OBT · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
217 daysmedian FDA review time
273 days90th percentile
6clearances 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 |
| K182704 | WishBone Guided Growth System | Wishbone Medical | 2019-06-25 | 271 | 1 |
| K180624 | Guided Growth Plate System Plus | Orthofix Srl | 2018-05-15 | 67 | 0 |
| K172183 | Guided Growth Plate System Plus | Orthofix Srl | 2018-01-09 | 174 | 0 |
| K110805 | GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEE | Orthofix, Inc. | 2011-06-21 | 90 | 0 |
| K093442 | GUIDED GROWTH SYSTEM | Orthofix, Inc. | 2010-06-10 | 217 | 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