510(k) K240678
- Device
- ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology
- Applicant
- Depuy Ireland UC
- 510(k) number
- K240678
- Product code
- MBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-06-18
- Date received
- 2024-03-11
- Regulation
- 888.3565
- Classification name
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/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
- Catherine O Regan
- Address
- Loughbeg Ringaskiddy Cork IE
FDA Registration Numbers#
- 3010057495
- 1649518
- 3017410889
- 3007913880
- 3006015326
- 1529009
- 3004371426
- 3007516837
- 3006694268
- 3008395353
- 3009173317
- 3005718816
- 3012319330
- 1061927
- 3009555447
- 3009555440
- 1018470
- 3010856250
- 3002806603
- 3006791286
- 3003541440
- 2246552
- 2245304
- 2183744
- 3004976965
- 3030412764
- 3025603301
- 1054811
- 2531477
- 1219602
- 3009106092
- 3011724582
- 3011295718
- 3015806723
- 3002806470
- 2528981
- 9681465
- 3020703621
- 3013014058
- 1833986
- 3002807310
- 3014162916
- 3005751028
- 3010388970
- 1064858
- 3022142628
- 3010287737
- 3012491394
- 3003387384
- 3009760038
- 3007923096
- 3015207155
- 3005360851
- 3011061242
- 3005852519
- 1043653
- 3010536692
- 1721676
- 1643264
- 3012725451
- 3016090213
- 3021902344
- 1000517406
- 3012130008
- 1020279
- 1226188
- 3005180920
- 3015978338
- 3014302784
- 3015542154
- 3010065126
- 3004142400
- 9613350
- 1038671
- 3002807314
- 3009973505
- 3008868758
- 8010379
- 3015231789
- 3011461101
Source Documents#
Other 510(k) Records For Product Code MBH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261275 | Unity Total Knee System, Unity Knee Cementless CR Femur | Corin, Ltd. | 2026-09-17 |
| K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | 2026-09-08 |
| K253728 | EVOLUTION® AM BIOFOAM® Tibial System | Microport Orthopedics, Inc. | 2026-08-21 |
| K251840 | Zimmer® Persona® Personalized Knee System | Zimmer, Inc. | 2026-05-28 |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | Zimmer, Inc. | 2026-03-09 |
| K253328 | GMK 3D Metal Tibial Tray Extension | Medacta International S.A. | 2026-02-26 |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026-02-18 |
| K253239 | Active-V Total Knee System; World Total Knee System | Signature Orthopaedics Pty, Ltd. | 2025-12-23 |
| K253161 | Balanced Knee System TriMax Porous Femoral Components | Ortho Development Corp. | 2025-12-19 |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. | 2025-10-31 |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-10-24 |
| K243656 | U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella | United Orthopedic Corporation | 2025-07-31 |
| K250980 | Physica System (Physica CR Porous Femoral components) | Lima Corporate S.P.A. | 2025-05-22 |
| K243768 | iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System | Restor3D, Inc. | 2025-03-27 |
| K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. | 2025-02-13 |