Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KRR — Predicate Candidate Screening
27 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
258 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231253 | Overture Orthopaedics Patellofemoral System | Overture Resurfacing, Inc. | 2023-07-07 | 67 | 0 |
| K221048 | Episealer Patellofemoral System | Episurf Medical, Inc. | 2022-12-23 | 259 | 0 |
| K211303 | Avon Patello-femoral Joint Prosthesis | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2021-06-04 | 36 | 0 |
| K200122 | MOTO PFJ System | Medacta International S.A. | 2020-04-20 | 90 | 0 |
| K181280 | Patello-Femoral Wave (Kahuna) Arthroplasty System | Arthrosurface, Inc. | 2018-06-14 | 30 | 3 |
| K160461 | Arthrex iBalance BiCompartmental Arthroplasty System | Arthrex, Inc. | 2016-04-12 | 53 | 0 |
| K143543 | Prelude PF Patellae | Biomet, Inc. | 2015-01-30 | 46 | 1 |
| K123907 | PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMOR | Biomet Manufacturing Corp | 2013-09-03 | 258 | 1 |
| K111970 | KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT | Tornier | 2012-02-23 | 227 | 0 |
| K082088 | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II | Mako Surgical Corp. | 2008-10-22 | 90 | 0 |
| K080029 | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM | Mako Surgical Corp. | 2008-05-16 | 133 | 0 |
| K073120 | ACCIN PATELLOFEMORAL SYSTEM | Accelerated Innovation, LLC | 2008-02-29 | 116 | 0 |
| K071413 | HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM | Arthrosurface, Inc. | 2007-11-09 | 172 | 0 |
| K070695 | ZIMMER PATELLOFEMORAL JOINT PROSTHESIS | Zimmer, Inc. | 2007-06-07 | 86 | 3 |
| K060127 | HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS | Arthrosurface, Inc. | 2006-03-16 | 57 | 0 |
| K050473 | RBK PATELLA FEMORAL KNEE | Global Orthopaedic Technology, USA, Inc. | 2005-11-14 | 263 | 0 |
| K051948 | AVON PATELLO-FEMORAL JOINT PROSTHESIS | Howmedica Osteonics Corp. | 2005-10-21 | 95 | 6 |
| K051086 | SMITH & NEPHEW PATELLO-FEMORAL IMPLANT | Smith & Nephew, Inc. | 2005-05-31 | 33 | 0 |
| K041160 | AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT | Howmedica Osteonics Corp. | 2004-05-27 | 24 | 0 |
| K013982 | KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT | Kinamed, Inc. | 2002-05-21 | 169 | 0 |
| K020841 | AVON PATELLAR COMPONENT | Howmedica Osteonics Corp. | 2002-04-11 | 27 | 0 |
| K010100 | AVON PATELLO-FEMORAL JOINT PROSTHESIS | Howmedica Osteonics Corp. | 2001-04-06 | 85 | 0 |
| K002356 | NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS | Sulzer Orthopedics, Inc. | 2000-10-30 | 89 | 0 |
| K001374 | PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT | Biomet Manufacturing, Inc. | 2000-07-27 | 87 | 0 |
| K001350 | PATIENT MATCHED TITANIUM ALLOY TROCHLEA | Biomet, Inc. | 2000-07-26 | 89 | 0 |
| K000827 | UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED | Walter Abendschein, M.D. | 2000-06-23 | 101 | 0 |
| K962190 | PATELLOFEMORAL JOINT PROSTHESIS | Intermedics Orthopedics | 1996-10-28 | 144 | 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