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510(k) K203421

Triathlon AS-1 by Conformis, Inc. — Product Code OOG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2021
Date Received
November 20, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knee Arthroplasty Implantation System
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.

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  • K231233 — Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS (May 26, 2023)
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  • 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)

Other clearances for product code OOG

  • K230850 — United Orthopedic Knee Patient Specific Instrumentation (December 20, 2023)