Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NEI · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
238 daysmedian FDA review time
878 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133285 | STRYKER TEMPORARY CONDYLAR PROSTHESIS | Stryker | 2014-04-09 | 166 | 0 |
| K081747 | MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM | Synthes (Usa) | 2008-09-05 | 78 | 0 |
| K063181 | SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM | Synthes (Usa) | 2007-01-05 | 78 | 0 |
| K031701 | OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM | Osteomed LP | 2004-07-08 | 402 | 0 |
| K002790 | ADD-ON CONDYLE | Walter Lorenz Surgical, Inc. | 2001-08-06 | 333 | 0 |
| K990667 | KLS-MARTIN TEMPORARY CONDYLAR IMPLANT | KLS-Martin L.P. | 2001-07-27 | 878 | 0 |
| K990637 | SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEA | Synthes (Usa) | 1999-10-22 | 238 | 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