Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KXA — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
79 daysmedian FDA review time
212 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201219 | Biocore9 Femoral Head Resurfacing Component | Biocore9, LLC | 2021-01-19 | 258 | 0 |
| K092198 | CORMET CEMENTLESS RESURFACING FEMORAL HEAD | Corin USA | 2010-04-15 | 268 | 0 |
| K082673 | CONSERVE PRESSFIT FEMORAL COMPONENT | Wrightmedicaltechnologyinc | 2008-12-12 | 88 | 0 |
| K071053 | RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD | Biomet, Inc. | 2007-06-29 | 77 | 0 |
| K070292 | DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS | Zimmer GmbH | 2007-04-26 | 85 | 3 |
| K062960 | CONSERVE FEMORAL RESURFACING COMPONENT | Wrightmedicaltechnologyinc | 2006-12-01 | 63 | 0 |
| K043542 | BIOPRO TARA FEMORAL RESURFACING COMPONENT | Biopro, Inc. | 2005-05-18 | 146 | 0 |
| K032659 | DEPUY ASR RESURFACING FEMORAL HEADS | DePuy Orthopaedics, Inc. | 2003-12-04 | 98 | 13 |
| K023188 | PRESS-FIT HEAD RESURFACING DEVICE | Biomet Orthopedics, Inc. | 2002-12-11 | 78 | 0 |
| K021549 | CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACIN | Std Mfg., Inc. | 2002-08-01 | 80 | 0 |
| K021799 | CEMENTED FEMORAL HEAD RESURFING DEVICE | Biomet Orthopedics, Inc. | 2002-06-26 | 26 | 0 |
| K994153 | CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS | Corin USA | 2000-02-25 | 79 | 0 |
| K983452 | NELSON RESURFACING HEAD | Biomet, Inc. | 1998-12-03 | 64 | 0 |
| K950998 | MODUILAR UNIPOLAR | Intermedics Orthopedics | 1995-04-13 | 41 | 0 |
| K944752 | ORTHOMET RESURFACING FEMORAL COMPONENT | Orthomet, Inc. | 1994-12-28 | 93 | 0 |
| K904870 | MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON | Endotec, Inc. | 1991-05-23 | 212 | 3 |
| K894604 | BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT | Biopro, Inc. | 1989-11-17 | 120 | 0 |
| K892398 | BIPOLAR HIP SYSTEM | Orthomet, Inc. | 1989-05-23 | 46 | 0 |
| K883212 | LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT | Implant Technology, Inc. | 1988-11-22 | 116 | 0 |
| K842233 | NEW JERSEY FEMORAL RESURFACING COMPONENT | Endomedics, Inc. | 1984-07-20 | 45 | 0 |
| K792200 | TILLMAN HIP RESURFACING REPLACEMT PROS. | Waldemar Link GmbH & Co. KG | 1979-12-05 | 34 | 0 |
| K781490 | TILLMAN HIPSURFACE REPLACEMENT | Waldemar Link GmbH & Co. KG | 1978-09-20 | 23 | 0 |
| K761324 | RESURFACE PROSTHESES FOR HIP JOINT | Holco Instrument Corp. | 1977-01-05 | 9 | 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