Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KWY — Predicate Candidate Screening
99 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
328 days90th percentile
99clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253357 | b-ONE® Bipolar Head | B-One Ortho, Corp. | 2026-04-13 | 195 | 0 |
| K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip) | Maxx Orthopedics, Inc. | 2025-08-25 | 273 | 0 |
| K231526 | CORAIL Cemented Femoral Stem | Depuy Ireland UC | 2023-12-19 | 207 | 0 |
| K223441 | SpaceFlex Acetabular Cup | G21, S.R.L. | 2023-03-23 | 129 | 0 |
| K221794 | Vario-Cup System | Waldemar Link GmbH & Co. KG | 2022-07-20 | 29 | 0 |
| K220492 | COPAL exchange G hip spacer | Heraeus Medical GmbH | 2022-03-23 | 29 | 0 |
| K200709 | Kyocera Bipolar Hip System | Kyocera Medical Technologies, Inc. | 2020-04-17 | 30 | 0 |
| K192236 | Fitmore Hip Stem | Zimmer GmbH | 2019-11-05 | 78 | 0 |
| K191016 | COPAL exchange G Hip and Knee Spacers | Heraeus Medical GmbH | 2019-11-01 | 198 | 0 |
| K191297 | iNSitu Bipolar Hip System | Theken Companies, LLC | 2019-09-17 | 126 | 1 |
| K191569 | Implantcast ic-Bipolar Head System | Implantcast GmbH | 2019-08-28 | 76 | 0 |
| K183114 | Corin BiPolar-i | Corin U.S.A. Limited | 2019-06-05 | 208 | 0 |
| K173455 | SurgTech Bipolar Head System | Surgtech, Inc. | 2018-06-14 | 219 | 0 |
| K180130 | ELEOS™ Bipolar Acetabular System | Onkos Surgical, Inc. | 2018-02-23 | 37 | 0 |
| K163081 | 40-42mm BiPolar Head and 22mm Femoral Head | Signature Orthopaedics Pty, Ltd. | 2018-01-29 | 452 | 0 |
| K170072 | Fitmore® Hip Stem | Zimmer GmbH | 2017-02-07 | 29 | 0 |
| K152439 | U2 Bipolar Implant and 22mm Femoral Head | United Orthopedic Corporation | 2016-04-07 | 224 | 0 |
| K143113 | Klassic BiPolar System | Total Joint Orthopedics | 2015-01-28 | 90 | 1 |
| K132539 | RING-LOK MODULAR BIPOLAR SYSTEM | Implants International, Ltd. | 2014-02-07 | 178 | 0 |
| K131354 | RENOVIS BIPOLAR HIP SYSTEM | Renovis Surgical Technologies, LLC | 2013-09-19 | 132 | 0 |
| K123991 | DEPUY CORAIL AMT HIP PROSTHESIS | Depuy France S.A.S. | 2013-09-16 | 264 | 0 |
| K121509 | TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, | Tgm Medical, Inc. | 2012-11-05 | 168 | 0 |
| K112019 | BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP | Corentec Co., Ltd. | 2011-10-12 | 90 | 0 |
| K100761 | BIOPRO POLAR HEAD | Biopro, Inc. | 2010-12-03 | 261 | 1 |
| K101670 | UNITED U2 BIPOLAR IMPLANT | United Orthopedic Corp. | 2010-10-08 | 116 | 1 |
| K100151 | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM) | Omnlife Science | 2010-05-28 | 129 | 0 |
| K091967 | MEDACTA BIPOLAR HEAD | Medacta International S.A. | 2010-03-02 | 244 | 0 |
| K082468 | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, X | Omni Life Science, Inc. | 2009-02-18 | 175 | 23 |
| K082705 | BIOPRO BIPOLAR HEAD, MODELS 18130-18152 | Biopro, Inc. | 2008-12-15 | 90 | 0 |
| K080979 | STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLAC | Biomet Manufacturing Corp | 2008-10-31 | 207 | 15 |
| K080647 | ACCIN BIPOLAR HEAD SYSTEM | Accelerated Innovation, LLC | 2008-07-08 | 123 | 0 |
| K062693 | GLADIATOR BIPOLAR SYSTEM | Wrightmedicaltechnologyinc | 2006-09-29 | 18 | 6 |
| K060707 | AESCULAP BIPOLAR ACETABULAR CUP | Aesculap, Inc. | 2006-05-31 | 76 | 0 |
| K052990 | STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PRO | Biomet, Inc. | 2005-12-16 | 53 | 4 |
| K050269 | U1 HIP SYSTEM - BIPOLAR | United Orthopedic Corp. | 2005-08-29 | 206 | 0 |
| K050966 | PIVOT BIPOLAR FEMORAL HEAD | Ortho Development Corp. | 2005-07-07 | 80 | 2 |
| K040947 | DURASUL BIPOLAR | Centerpulse Orthopedics, Inc. | 2004-08-27 | 137 | 0 |
| K023743 | SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM | Smith & Nephew, Inc. | 2003-01-23 | 77 | 1 |
| K014072 | FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) | Disc-O-Tech Medical Technologies, Ltd. | 2002-03-08 | 88 | 0 |
| K013211 | MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS | Exactech, Inc. | 2001-12-05 | 70 | 1 |
| K010081 | ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS | Exactech, Inc. | 2001-02-05 | 26 | 0 |
| K003363 | M2A 32MM TAPER SYSTEM | Biomet, Inc. | 2000-12-15 | 49 | 0 |
| K991990 | TRI-POLAR SYSTEM | Biomet, Inc. | 1999-09-10 | 88 | 0 |
| K982812 | G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) | Johnson & Johnson Professionals, Inc. | 1998-12-04 | 115 | 0 |
| K982447 | PLUS BIPOLAR PROSTHESIS COCRMO | Plus Orthopedics | 1998-11-25 | 133 | 0 |
| K982389 | ODC B2 BIPOLAR CUP | Ortho Development Corp. | 1998-10-07 | 90 | 0 |
| K981238 | BIPOLAR FEMORAL HEAD | Whiteside Biomechanics, Inc. | 1998-08-21 | 140 | 0 |
| K980801 | J-FX BIPOLAR HEAD | Johnson & Johnson Professionals, Inc. | 1998-05-29 | 88 | 0 |
| K970447 | IMPLEX BIPOLAR HIP SYSTEM | Implex Corp. | 1997-04-30 | 83 | 0 |
| K970284 | ARTOS, DIPLOS SYSTEM | Turnkey Intergration USA, Inc. | 1997-04-21 | 87 | 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