Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LWJ — Predicate Candidate Screening
81 FDA 510(k) clearances under this product code; the 50 most recent screened below.
99 daysmedian FDA review time
263 days90th percentile
81clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120595 | UNISYN PLUS HIP STEM | Consensus Orthopedics, Inc. | 2012-10-12 | 227 | 0 |
| K103518 | TRINITY ACETABULAR SYSTEM | Corin USA | 2011-03-09 | 99 | 0 |
| K090764 | NOVATION CFS PRESS-FIT AND CEMENTED STEMS | Exactech, Inc. | 2009-04-21 | 29 | 0 |
| K082146 | METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD | Aesculap Implant Systems, Inc. | 2008-09-09 | 41 | 0 |
| K070061 | 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT | Hayes Medical, Inc. | 2007-01-31 | 26 | 0 |
| K062978 | U2 HIP STEM, TI PLASMA SPRAY | United Orthopedic Corp. | 2007-01-16 | 109 | 0 |
| K062383 | UNISYN HA PLASMA MODULAR HIP | Hayes Medical, Inc. | 2006-12-21 | 128 | 0 |
| K061699 | EXCIA | Aesculap, Inc. | 2006-08-18 | 63 | 0 |
| K051826 | BETACONE HIP PROSTHESIS SYSTEM | Waldemar Link GmbH & Co. KG | 2005-11-18 | 136 | 0 |
| K050262 | U2 ACETABULAR COMPONENT | United Orthopedic Corp. | 2005-08-15 | 192 | 0 |
| K042344 | EXCIA TOTAL HIP SYSTEM | Aesculap, Inc. | 2005-03-16 | 198 | 10 |
| K040685 | Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED | Osteoimplant Technology, Inc. | 2005-01-25 | 315 | 0 |
| K033313 | QUATRO M FEMORAL COMPONENT | Whiteside Biomechanics, Inc. | 2004-07-28 | 287 | 0 |
| K032709 | MODULAR PLUS HIP STEM | Plus Orthopedics | 2003-09-23 | 21 | 0 |
| K032110 | PROCLASS PRESS FIT HIP STEM | Stelkast Company | 2003-09-22 | 75 | 0 |
| K030971 | MODIFICATION TO MODULAR PLUS REVISION STEM | Plus Orthopedics | 2003-04-24 | 27 | 0 |
| K023692 | GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER | Howmedica Osteonics Corp. | 2003-03-20 | 136 | 0 |
| K030122 | DEPUY SUMMIT BASIC PRESS-FIT HIP STEM | DePuy Orthopaedics, Inc. | 2003-02-05 | 22 | 0 |
| K024134 | UNI HIP STEM | Plus Orthopedics | 2003-01-15 | 30 | 0 |
| K022966 | PROXILOCK HIP PROSTHESIS; SIZE 12/36 | Implex Corp. | 2002-10-02 | 26 | 0 |
| K003649 | TRITON HIP SYSTEM | Hayes Medical, Inc. | 2001-02-23 | 88 | 0 |
| K010243 | TRI-FIT FEMORAL STEM | Corin USA | 2001-02-15 | 21 | 0 |
| K003016 | PRO-FEMUR R | Wrightmedicaltechnologyinc | 2000-12-13 | 77 | 9 |
| K994146 | EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP | Plus Orthopedics | 2000-12-11 | 369 | 0 |
| K002941 | ACETABULAR PLATES | Encore Orthopedics, Inc. | 2000-12-04 | 74 | 0 |
| K002575 | INTER-OP DURASUL ACETABULAR INSERTS (4MM) | Sulzer Orthopedics, Inc. | 2000-11-15 | 89 | 0 |
| K002796 | MODIFICATION TO PROVIDENT HIP SYSTEM | Stelkast Company | 2000-09-28 | 21 | 0 |
| K002141 | ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS- | Exactech, Inc. | 2000-08-16 | 30 | 0 |
| K001471 | THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ | Implex Corp. | 2000-08-07 | 88 | 0 |
| K001745 | MODIFICATION TO PROVIDENT HIP SYSTEM | Stelkast Company | 2000-07-27 | 49 | 0 |
| K001942 | SL-PLUS AND SLR-PLUS STEMS | Plus Orthopedics | 2000-07-25 | 29 | 0 |
| K994126 | MODULAR-PLUS REVISION STEM | Plus Orthopedics | 2000-05-04 | 149 | 0 |
| K993601 | HOWMEDICA OSTEONICS FEMORAL HEADS | Howmedica Osteonics Corp. | 1999-11-16 | 22 | 3 |
| K982936 | OSTEONICS EXTENDED FEMORAL BEARING HEAD | Osteonics Corp. | 1998-10-21 | 61 | 0 |
| K971900 | LATERAL FLARE INTERNAL COLLAR (LFIC) | Pro-Lfic, LLC | 1997-12-18 | 209 | 0 |
| K972931 | PLUS EPF ACETABULAR CUP | Hhl Consulting | 1997-11-13 | 97 | 0 |
| K973077 | PLUS-FIT ACETABULAR CUP | Plus Orthopedics | 1997-11-13 | 87 | 0 |
| K964178 | PRESS-FIT HIP STEM | Encore Orthopedics, Inc. | 1997-05-05 | 199 | 0 |
| K955553 | PERFECTA REVISION HIP SYSTEM | Wrightmedicaltechnologyinc | 1996-10-24 | 324 | 0 |
| K962034 | SC, CEMENTLESS HIP SYSTEM | Artos Medical Products GmbH | 1996-10-23 | 152 | 0 |
| K962268 | CHROME COBALT BALL HEAD | Artos Medical Products GmbH | 1996-10-23 | 132 | 0 |
| K961378 | DELTA HIP PROSTHESIS | Zimmer, Inc. | 1996-10-08 | 181 | 4 |
| K963155 | INTERMOORE FRACTURE HIP STEM (MODIFY) | Intermedics Orthopedics | 1996-10-01 | 57 | 0 |
| K960633 | PRESS-FIT FLARED SHELL | Encore Orthopedics, Inc. | 1996-10-01 | 230 | 0 |
| K960908 | SRRS PRESSED FIT FEMORAL REVISION COMPONENT | Stelkast Company | 1996-08-08 | 156 | 0 |
| K954854 | INTERMOORE FRACTURE HIP STEM | Intermedics Orthopedics | 1996-02-15 | 115 | 0 |
| K952776 | LFIC OR FETTO HIP | Zimmer, Inc. | 1996-02-14 | 243 | 0 |
| K953268 | DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT | Stelkast Company | 1996-01-17 | 188 | 2 |
| K952297 | FOUNDATION TEXTURED STEM | Encore Orthopedics, Inc. | 1995-07-17 | 62 | 0 |
| K950541 | HOWMEDICA V40 22MM FEMORAL HEAD | Howmedica Corp. | 1995-03-21 | 42 | 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