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510(k) K241570

Unity Total Knee System by Corin U.S.A. Limited — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2024
Date Received
May 31, 2024
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 Corin U.S.A. Limited

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  • K241472 — Icona Hip Stem (October 3, 2024)
  • K240875 — Unity Knee PS-C Tibial Insert (June 26, 2024)
  • K231172 — ApolloKnee (July 26, 2023)
  • K212069 — Corin MetaFix™ Hip Stem (April 7, 2022)
  • K191831 — MobiliT Cup (January 16, 2020)
  • K191374 — Revival Modular Hip Stem (July 22, 2019)
  • K183114 — Corin BiPolar-i (June 5, 2019)
  • K183533 — Unity Total Knee System (June 4, 2019)

Other clearances for product code JWH

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  • K253197 — ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (November 19, 2025)
  • K253314 — Freedom Infinia™ Total Knee System (October 29, 2025)
  • K253144 — Freedom® Total Knee System – Titan PCK Components (October 22, 2025)
  • K252725 — Stem Extension Line (U2 Total Knee System—PSA Type) (September 25, 2025)
  • K251554 — Materialise TKA Guide System (July 14, 2025)
  • K251776 — EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) (July 8, 2025)
  • K251241 — EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) (July 2, 2025)
  • K251717 — Freedom® Total Knee System – Titanium Tibial Base Plate (June 26, 2025)