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510(k) K223316

Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System by Conformis, Inc. — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2023
Date Received
October 28, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3565
Review Panel
OR
Submission Type

Other clearances by Conformis, Inc.

  • K232426 — Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) wi (September 8, 2023)
  • 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)
  • K212411 — Identity Imprint Knee Replacement System (including Identity Imprint Posterior S (September 23, 2021)

Other clearances for product code MBH

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  • K253239 — Active-V Total Knee System; World Total Knee System (December 23, 2025)
  • K253161 — Balanced Knee System TriMax Porous Femoral Components (December 19, 2025)
  • K252777 — Freedom Metaphyseal Cone Implants (Metaphyseal Cones) (October 31, 2025)
  • K252044 — Triathlon® Total Knee System - Triathlon® Gold Femoral Components (October 24, 2025)
  • K243656 — U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella (July 31, 2025)
  • K250980 — Physica System (Physica CR Porous Femoral components) (May 22, 2025)
  • K243768 — iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System (March 27, 2025)