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510(k) K251771

Cambridge Partial Knee by Signature Orthopaedics Pty, Ltd. — Product Code HSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2025
Date Received
June 10, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3520
Review Panel
OR
Submission Type

Other clearances by Signature Orthopaedics Pty, Ltd.

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  • K243043 — Origin™ Cemented Hip Stem (May 2, 2025)
  • K243029 — Origin™ TT Stem (March 11, 2025)
  • K243162 — World Liner (November 25, 2024)
  • K240683 — Rx Knee System (September 11, 2024)
  • K241690 — Logical Liner; World Liner; World Knee Patella (August 1, 2024)

Other clearances for product code HSX

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  • K221292 — Uni Knee Resurfacing System (March 10, 2023)
  • K212870 — TLC Unicompartmental Knee System (June 16, 2022)
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