Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NJD · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
133 daysmedian FDA review time
269 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251975 | Achieve Partial Knee System - Porous Coated CoCrMo Femoral C | Ignite Orthomotion | 2025-09-02 | 68 | 0 |
| K242307 | ACHIEVE Partial Knee System | Ignite Orthomotion | 2024-12-16 | 133 | 0 |
| K222653 | JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System | Smith+Nephew, Inc. | 2022-10-28 | 57 | 0 |
| K190439 | Engage™ Partial Knee System | Engage Uni, LLC | 2019-11-21 | 269 | 4 |
| K133811 | RESTORIS POROUS PARTIAL KNEE SYSTEM | Mako Surgical Corp. | 2014-07-08 | 204 | 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