Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System
FDA 510(k) K213389 · Conformis, Inc.
510(k) numberK213389
Submission
- Device name
- Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System
- Applicant
- Conformis, Inc.
Billerica, MA, US - Received
- October 15, 2021
- Decision date
- November 10, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3560
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JWH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260063 | GSPE SpacerJWH · Traditional | The General Hospital Corporation, d/b/a… | 09/11/2026SE |
| K262293 | EVOLUTION MPX Total Knee SystemJWH · Traditional | Suzhou Microport Orthorecon Co., Ltd. | 09/10/2026SE |
| K262341 | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and…JWH · Traditional | B-One Ortho, Corp. | 09/08/2026SE |
| K262130 | ATTUNE Revision Knee SystemJWH · Traditional | Depuy Orthopaedics, Inc. | 09/04/2026SE |
| K253961 | SK Knee SystemJWH · Traditional | Just Medical Devices (Tianjin) Co., Ltd. | 09/01/2026SE |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners)JWH · Traditional | Maxx Orthopedics, Inc. | 08/07/2026SE |
| K262251 | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)JWH · Special | Globus Medical, Inc. | 07/31/2026SE |
| K261734 | Klassic Infection Spacer SystemJWH · Traditional | Total Joint Orthopedics, Inc. | 07/23/2026SE |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee SystemJWH · Traditional | DePuy Ireland UC | 06/25/2026SE |
| K261032 | NovoKnee (SteriKnee)JWH · Special | NovoSource | 04/27/2026SE |
More from NovoSource
| 510(k) | Device | Decision |
|---|---|---|
| K232426 | Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…MBH · Special | 09/08/2023SE |
| 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 |
| K212411 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior…JWH · Traditional | 09/23/2021SE |
Questions and answers
When was Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System cleared by the FDA?
Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System (K213389) received a 510(k) decision of Substantially Equivalent on November 10, 2021, 26 days after the submission was received.
What is the product code of K213389?
The FDA product code is JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3560.