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510(k) K210191

Identity Imprint Knee Replacement System by Conformis, Inc. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2021
Date Received
January 25, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

Other clearances by Conformis, Inc.

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  • K230846 — iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement Syste (July 17, 2023)
  • K231233 — Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS (May 26, 2023)
  • K231178 — ACTERA™ hip system (May 23, 2023)
  • K230844 — Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruc (April 27, 2023)
  • K221104 — Actera™ hip system (August 4, 2022)
  • K221404 — Identity Imprint Knee Replacement System (including Identity Imprint Posterior S (July 26, 2022)
  • K221059 — Identity Imprint Knee Replacement System (including Identity Imprint Posterior S (May 10, 2022)
  • K213389 — Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Im (November 10, 2021)

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  • K253144 — Freedom® Total Knee System – Titan PCK Components (October 22, 2025)
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