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510(k) K221104

Actera™ hip system by Conformis, Inc. — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2022
Date Received
April 14, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device Class
Class II
Regulation Number
888.3353
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)
  • 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 MEH

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  • K243839 — Alteon® HA Femoral Stems (March 10, 2025)
  • K243162 — World Liner (November 25, 2024)
  • K241472 — Icona Hip Stem (October 3, 2024)
  • K241875 — TheRay Collared and Collarless Femoral Stem (September 13, 2024)
  • K241690 — Logical Liner; World Liner; World Knee Patella (August 1, 2024)
  • K233758 — Trivicta™ Hip Stem (March 8, 2024)