510(k) K221048
- Device
- Episealer Patellofemoral System
- Applicant
- Episurf Medical, Inc.
- 510(k) number
- K221048
- Product code
- KRR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-12-23
- Date received
- 2022-04-08
- 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
- Katarina Flodstrom
- Address
- 220 E 42nd St., Suite 409a New York NY US 10017 10017
FDA Registration Numbers#
- 3027556146
- 9616680
- 2027148
- 2029275
- 2528981
- 3022142628
- 2244478
- 3021008900
- 9681739
- 3010392243
- 3016851379
- 3033509898
- 3015341893
- 3010400367
- 3008110533
- 2648920
- 3002907620
- 1421101
- 3009973505
- 3010331645
- 1043653
- 3011061242
- 2249697
- 3008868758
- 3006395932
- 2028632
- 2245304
- 3017410889
- 3010097171
- 3003617485
- 1018470
- 8043792
- 1057425
- 1818910
- 3000264985
- 1220477
- 3005061536
- 3010220595
- 3009888740
- 9680235
- 3015231789
- 3010041693
- 3010047402
- 3005180920
- 3005551626
- 1020279
- 1061927
- 3003639920
- 1825034
- 1226544
- 3007539489
- 3004154314
- 3013055499
- 1828288
- 1822565
- 3016438694
- 3009848551
- 1526534
- 3025603301
- 1219655
- 1220246
- 3012392319
- 3015207155
- 3010173425
- 3004748528
- 1828464
- 3009882462
- 2249615
- 3003477135
- 3013302242
- 3002807310
- 3006801265
- 3002579136
- 1834331
- 3006946276
- 1054811
- 3010163695
- 3011295718
- 3002807295
Source Documents#
Other 510(k) Records For Product Code KRR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231253 | Overture Orthopaedics Patellofemoral System | Overture Resurfacing, Inc. | 2023-07-07 |
| 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 |