510(k) K243768
- Device
- iTotal® Identity? Cruciate Retaining 3DP Porous Knee Replacement System
- Applicant
- Restor3D, Inc.
- 510(k) number
- K243768
- Product code
- MBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-27
- Date received
- 2024-12-06
- 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
- Brianna Prindle
- Address
- 4001 Nc 54, Suite 3160 Durham NC US 27709 27709
FDA Registration Numbers#
- 3042172882
- 3007539489
- 3010155661
- 2242737
- 3010331645
- 3015916578
- 3015806723
- 1828464
- 1526534
- 1818910
- 3002807314
- 3002806603
- 2528981
- 3003541440
- 1000517406
- 1721676
- 1720929
- 3011015572
- 1424263
- 3010039400
- 3014162916
- 3004748528
- 9681465
- 3003477135
- 3007311878
- 3004371426
- 3009973336
- 9616671
- 2032093
- 3007963827
- 1833986
- 3002993234
- 3002806470
- 3036773273
- 2249615
- 3012491394
- 2648920
- 3014833750
- 9616680
- 1220246
- 3016090213
- 3033509898
- 3004450489
- 1822565
- 3006694268
- 1825034
- 3020155054
- 3010388970
- 9610726
- 1226188
- 3016851379
- 1833920
- 3009732568
- 3004153240
- 3007923096
- 1054811
- 1038671
- 3035366890
- 2183744
- 1646498
- 3007516837
- 3005751028
- 3008544874
- 1220477
- 3019006180
- 1057425
- 3015516266
- 3000264985
- 2245304
- 3009475821
- 3015231789
- 1649518
- 3015542154
- 3008812251
- 3005874553
- 1827096
- 3012392319
- 3009923578
- 1423662
- 1000200989
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 |
| 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 |
| K242412 | Agility Symmetric™ Total Knee System | Medisurge, LLC | 2024-11-06 |