Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KWL — Predicate Candidate Screening
108 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
229 days90th percentile
108clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular Cup | Osteoremedies, LLC | 2026-07-24 | 18 | 0 |
| K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Ceme | Depuy Ireland UC | 2026-05-15 | 87 | 0 |
| K253675 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | 2025-12-23 | 32 | 0 |
| K252326 | InterSpace GV Hip Spacer | Tecres S.P.A. | 2025-08-06 | 12 | 0 |
| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Sp | Biocomposites, Ltd. | 2025-06-12 | 265 | 0 |
| K234028 | COPAL® exchange G hip spacer; COPAL® G+V | Heraeus Medical GmbH | 2024-02-15 | 57 | 0 |
| K222632 | UHR Bipolar Implants, Restoration GAP II Implants | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-10-21 | 51 | 0 |
| K192995 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | 2020-01-10 | 77 | 0 |
| K191981 | REMEDY Acetabular Cup | Osteoremedies, LLC | 2019-08-23 | 30 | 0 |
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement | Osteoremedies, LLC | 2018-08-29 | 341 | 0 |
| K173967 | Remedy Acetabular Cup | Osteoremedies, LLC | 2018-02-22 | 55 | 0 |
| K143184 | Evolve UniPolar Head | Signature Orthopaedics Pty, Ltd. | 2015-03-17 | 132 | 0 |
| K112470 | 2GC HIP/KNEE MODULAR SPACER | Mandell Horwitz Consultants, LLC | 2012-04-05 | 223 | 0 |
| K101356 | Spacer-G and Spacer-K | Tecres S.P.A. | 2011-09-20 | 494 | 0 |
| K111911 | CORIN OPTIMOM MODULAR HEAD | Corin USA | 2011-08-04 | 30 | 0 |
| K062273 | SPACER-G TEMPORARY HIP PROSTHESIS | Tecres S.P.A. | 2008-05-22 | 654 | 0 |
| K071471 | CORIN ADAPTOR SLEEVE | Howmedica Osteonics Corp. | 2007-09-10 | 104 | 1 |
| K063791 | CORIN UNIPOLAR MODULAR HEAD | Corin USA | 2007-04-03 | 102 | 0 |
| K062408 | SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD | Smith & Nephew, Inc. | 2006-09-12 | 26 | 0 |
| K061243 | SMITH & NEPHEW MODULAR FEMORAL HEAD | Smith & Nephew, Inc. | 2006-07-17 | 75 | 0 |
| K042973 | SOLITUDE UNIPOLAR HEAD | Ortho Development Corp. | 2005-01-27 | 91 | 0 |
| K031841 | SPACER G TEMPORARY HIP PROSTHESIS | Exactech, Inc. | 2004-01-22 | 220 | 0 |
| K030972 | FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH) | Disc-O-Tech Medical Technologies, Ltd. | 2003-05-30 | 63 | 0 |
| K030205 | CONSENSUS UNIPOLAR HEAD, COCR | Hayes Medical, Inc. | 2003-04-01 | 70 | 0 |
| K014226 | UNITRAX MODULAR UNIPOLAR SYSTEM | Howmedica Osteonics Corp. | 2002-01-25 | 30 | 3 |
| K992570 | UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE | Howmedica Osteonics Corp. | 1999-09-01 | 30 | 0 |
| K990309 | PLUS FRACTURE HEAD PROSTHESIS | Plus Orthopedics | 1999-03-15 | 42 | 0 |
| K984585 | OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE | Osteonics Corp. | 1999-02-24 | 62 | 0 |
| K984028 | THE NEW BIO-MOORE ENDO HEADS | Biomet, Inc. | 1999-01-19 | 68 | 0 |
| K981451 | ARGOMEDICAL BIPOLAR SYSTEM | Stelkast Company | 1998-08-21 | 121 | 0 |
| K974807 | OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM | Osteonics Corp. | 1998-03-16 | 83 | 0 |
| K973614 | FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SL | Encore Orthopedics, Inc. | 1997-12-18 | 86 | 0 |
| K965198 | ULTIMA TPS CEMENTED STEM | Johnson & Johnson International | 1997-07-23 | 209 | 0 |
| K965156 | ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES | Johnson & Johnson Professionals, Inc. | 1997-01-24 | 32 | 0 |
| K962646 | PRIME MODULAR ENDO HEAD | Orthopaedic Innovations, Inc. | 1996-09-23 | 77 | 0 |
| K960538 | OPTEON UNIPOLAR | Exactech, Inc. | 1996-03-27 | 49 | 0 |
| K955385 | JOHNSON & JOHNSON AUSTIN MOORE STEM | Johnson & Johnson Professionals, Inc. | 1996-01-30 | 67 | 0 |
| K954534 | OSTEONICS UNIPOLAR ENDO HEAD | Osteonics Corp. | 1995-11-30 | 62 | 0 |
| K954077 | UNITRAX V40 MODULAR ADAPTOR | Howmedica Corp. | 1995-11-15 | 77 | 0 |
| K943778 | OSTEONICS RESTORATION CEMENTED HIP STEM SERIES | Osteonics Corp. | 1995-08-14 | 377 | 0 |
| K950563 | ULTIMA AUGMENTED UHMWPE CUP | Johnson & Johnson Professionals, Inc. | 1995-06-07 | 119 | 0 |
| K951355 | LINK SADDLE PROTHESIS | Turnkey Intergration USA, Inc. | 1995-05-25 | 78 | 0 |
| K931752 | CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION | Corin Orthopedic Products | 1994-10-07 | 547 | 0 |
| K931753 | CORIN THOMPSON PROSTHESIS, MODIFICATION | Corin Orthopedic Products | 1994-10-07 | 547 | 0 |
| K940190 | ULTIMA UNIPOLAR MODULAR HEAD | Johnson & Johnson Orthopaedics, Inc. | 1994-09-29 | 259 | 0 |
| K934353 | ZIRCONIUM ALLOY UNI-POLAR HEAD | Smith & Nephew Richards, Inc. | 1994-04-25 | 229 | 0 |
| K924050 | TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT | Orthomet, Inc. | 1993-08-25 | 385 | 0 |
| K926120 | CONTOUR FEMORAL HIP STEM WITH POROCOAT | Depuy, Inc. | 1993-03-31 | 118 | 0 |
| K924379 | ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM | Johnson & Johnson Orthopaedics, Inc. | 1993-02-12 | 165 | 0 |
| K922146 | OSTRONCS HEMI-HIP STEM SERIES | Osteonics Corp. | 1992-08-11 | 96 | 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