510(k) K231253
- Device
- Overture Orthopaedics Patellofemoral System
- Applicant
- Overture Resurfacing, Inc.
- 510(k) number
- K231253
- Product code
- KRR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-07-07
- Date received
- 2023-05-01
- Regulation
- 888.3540
- Classification name
- Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Riley Williams
- Address
- 1617 3rd Ave., #287284 New York NY US 10128 10128
FDA Registration Numbers#
- 3002579136
- 3016851379
- 1000200989
- 3015806723
- 3004154314
- 2027148
- 1828288
- 3005551626
- 1220477
- 3035366890
- 3013055499
- 3010097171
- 1018470
- 1825034
- 3002807295
- 3007366790
- 3006801265
- 3021008900
- 3007539489
- 3003639920
- 3010163695
- 3005061536
- 1421101
- 3015516266
- 3007963827
- 3009848551
- 1043653
- 1054811
- 2245304
- 9681465
- 1450662
- 1219655
- 3003617485
- 3009888740
- 3036756245
- 3010392243
- 2244478
- 3015231789
- 3006946276
- 3011295718
- 3002807310
- 3017597868
- 2528981
- 9610569
- 3005180920
- 3038503932
- 3004748528
- 3009973336
- 3010220595
- 3017410889
- 1827096
- 2648920
- 3013302242
- 3013014058
- 3011061242
- 3025603301
- 2249615
- 3006017180
- 3011683674
- 3033509898
- 3010039400
- 1526534
- 3002907620
- 2029275
- 3014302784
- 1057425
- 3013176080
- 9616680
- 3010178296
- 1835251
- 3015341893
- 3009882462
- 1834331
- 1822565
- 3016438694
- 3000264985
- 1020279
- 1833920
- 1643264
- 3003477135
Source Documents#
Other 510(k) Records For Product Code KRR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221048 | Episealer Patellofemoral System | Episurf Medical, Inc. | 2022-12-23 |
| K211303 | Avon Patello-femoral Joint Prosthesis | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2021-06-04 |
| K200122 | MOTO PFJ System | Medacta International S.A. | 2020-04-20 |
| K181280 | Patello-Femoral Wave (Kahuna) Arthroplasty System | Arthrosurface, Inc. | 2018-06-14 |
| K160461 | Arthrex iBalance BiCompartmental Arthroplasty System | Arthrex, Inc. | 2016-04-12 |
| K143543 | Prelude PF Patellae | Biomet, Inc. | 2015-01-30 |
| K123907 | PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, | Biomet Manufacturing Corp | 2013-09-03 |
| K111970 | KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT | Tornier | 2012-02-23 |
| K082088 | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II | Mako Surgical Corp. | 2008-10-22 |
| K080029 | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM | Mako Surgical Corp. | 2008-05-16 |
| K073120 | ACCIN PATELLOFEMORAL SYSTEM | Accelerated Innovation, LLC | 2008-02-29 |
| K071413 | HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM | Arthrosurface, Inc. | 2007-11-09 |
| K070695 | ZIMMER PATELLOFEMORAL JOINT PROSTHESIS | Zimmer, Inc. | 2007-06-07 |
| K060127 | HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS | Arthrosurface, Inc. | 2006-03-16 |
| K050473 | RBK PATELLA FEMORAL KNEE | Global Orthopaedic Technology, USA, Inc. | 2005-11-14 |