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
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Applicant Contact
- Contact
- Brianna Prindle
- Address
- 4001 Nc 54, Suite 3160 Durham NC US 27709 27709
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00840097515205 | iTotal Identity 3DP Porous Knee | Restor3d, Inc. | 2025-12-02 |
| 00840097515199 | iTotal Identity 3DP Porous Knee | Restor3d, Inc. | 2025-12-02 |
| 00840097515182 | iTotal Identity 3DP Porous Knee | Restor3d, Inc. | 2025-12-02 |
| 00840097515175 | iTotal Identity 3DP Porous Knee | Restor3d, Inc. | 2025-12-02 |
| 00840097515168 | iTotal Identity 3DP Porous Knee | Restor3d, Inc. | 2025-12-02 |
| 00840097515151 | iTotal Identity 3DP Porous Knee | Restor3d, Inc. | 2025-12-02 |
| 00840097515144 | iTotal Identity 3DP Porous Knee | Restor3d, Inc. | 2025-12-02 |
| 00840097515137 | iTotal Identity 3DP Porous Knee | Restor3d, Inc. | 2025-12-02 |
| 00840097515120 | iTotal Identity 3DP Porous Knee | Restor3d, Inc. | 2025-12-02 |
| 00840097515113 | iTotal Identity 3DP Porous Knee | Restor3d, Inc. | 2025-12-02 |
| 00840097515106 | iTotal Identity 3DP Porous Knee | Restor3d, Inc. | 2025-12-02 |
| 00840097515090 | iTotal Identity 3DP Porous Knee | Restor3d, Inc. | 2025-12-02 |
| 00840097515083 | iTotal Identity 3DP Porous Knee | Restor3d, Inc. | 2025-12-02 |
| 00840097515076 | iTotal Identity 3DP Porous Knee | Restor3d, Inc. | 2025-12-02 |
| 00840097515069 | iTotal Identity 3DP Porous Knee | Restor3d, Inc. | 2025-12-02 |
Other 510(k) Records For Product Code MBH
| 510(k) | Device | Applicant | Decision date |
|---|
| 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 |
| K243247 | Persona the Personalized Knee System | Zimmer, Inc. | 2024-10-29 |