510(k) K212941
- Device
- Porous Patella
- Applicant
- Encore Medical, L.P. Dba DJO Surgical
- 510(k) number
- K212941
- Product code
- MBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-01-20
- Date received
- 2021-09-15
- 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
- Michael A Siano
- Address
- 9800 Metric Blvd. Austin TX US 78758 78758
FDA Registration Numbers#
- 1226188
- 3014302784
- 1424263
- 3010220595
- 3005852519
- 3035366890
- 3002993234
- 9617840
- 1825034
- 3015806723
- 3015207155
- 3010009693
- 3009848551
- 3006791286
- 3005180920
- 3007913880
- 3013791180
- 3014162916
- 1057425
- 3006356043
- 3007963827
- 1722511
- 1054811
- 3013417938
- 3012130008
- 3038503932
- 3000264985
- 3004450489
- 3012319330
- 2242737
- 1043653
- 2249697
- 3008395353
- 1833920
- 2183946
- 3010057495
- 3004153240
- 1319660
- 1000200989
- 3008812251
- 3016470314
- 3006015326
- 3005279746
- 3009760038
- 3013014058
- 3011187779
- 1220246
- 3005144609
- 3010287737
- 3013176080
- 3010375065
- 3004748528
- 3008868758
- 3020155054
- 3015542154
- 1646498
- 3009923578
- 9681465
- 3012329926
- 1835572
- 3025603301
- 3010856250
- 9613369
- 2246552
- 3005562917
- 9680215
- 1000517406
- 1018470
- 3014763043
- 1526534
- 3002807310
- 3009887475
- 3009555447
- 3009732568
- 3002579136
- 1721676
- 3003387384
- 3002806470
- 1833986
Source Documents#
Other 510(k) Records For Product Code MBH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K243293 | Zimmer® Persona® Personalized Knee System | Zimmer Biomet | 2024-12-20 |
| K243615 | Physica Porous Femoral Components | Lima Corporate S.P.A. | 2024-12-18 |
| K242543 | Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) | Zimmer, Inc. | 2024-11-22 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases