Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts
FDA 510(k) K232426 · Conformis, Inc.
510(k) numberK232426
Submission
- Device name
- Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts
- Applicant
- Conformis, Inc.
Billerica, MA, US - Received
- August 11, 2023
- Decision date
- September 8, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3565
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MBH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261462 | LANDMARK Total Knee SystemMBH · Traditional | Smith & Nephew, Inc. | 09/08/2026SE |
| K253728 | EVOLUTION® AM BIOFOAM® Tibial SystemMBH · Traditional | Microport Orthopedics, Inc. | 08/21/2026SE |
| K251840 | Zimmer® Persona® Personalized Knee SystemMBH · Traditional | Zimmer, Inc. | 05/28/2026SE |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)MBH · Traditional | Zimmer, Inc. | 03/09/2026SE |
| K253328 | GMK 3D Metal Tibial Tray ExtensionMBH · Traditional | Medacta International S.A. | 02/26/2026SE |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertMBH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 02/18/2026SE |
| K253239 | Active-V Total Knee System; World Total Knee SystemMBH · Traditional | Signature Orthopaedics Pty, Ltd. | 12/23/2025SE |
| K253161 | Balanced Knee System TriMax Porous Femoral ComponentsMBH · Traditional | Ortho Development Corp. | 12/19/2025SE |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones)MBH · Traditional | Maxx Orthopedics, Inc. | 10/31/2025SE |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsMBH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 10/24/2025SE |
More from Howmedica Osteonics Corp., Dba Stryker Orthopaedics
| 510(k) | Device | Decision |
|---|---|---|
| K223316 | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…MBH · Traditional | 07/21/2023SE |
| K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemJWH · Traditional | 07/17/2023SE |
| K231233 | Identity Imprint CR KRS and Identity Imprint PS KRSJWH · Special | 05/26/2023SE |
| K231178 | ACTERA hip systemMEH · Special | 05/23/2023SE |
| K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…JWH · Special | 04/27/2023SE |
| K221104 | Actera hip systemMEH · Traditional | 08/04/2022SE |
| K221404 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior…JWH · Traditional | 07/26/2022SE |
| K221059 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior…JWH · Special | 05/10/2022SE |
| K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…JWH · Special | 11/10/2021SE |
| K212411 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior…JWH · Traditional | 09/23/2021SE |
Questions and answers
When was Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts cleared by the FDA?
Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts (K232426) received a 510(k) decision of Substantially Equivalent on September 8, 2023, 28 days after the submission was received.
What is the product code of K232426?
The FDA product code is MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3565.