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510(k) K243029

Origin™ TT Stem by Signature Orthopaedics Pty, Ltd. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2025
Date Received
September 27, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

Other clearances by Signature Orthopaedics Pty, Ltd.

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  • K243021 — Longboard Revision Hip Stem (August 7, 2025)
  • K242674 — Freedom Posterior Cervical Screws (May 13, 2025)
  • K242477 — Shoulder Soft Tissue Anchors (May 12, 2025)
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  • 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 LZO

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  • K250450 — Coated hip implants (September 19, 2025)
  • K243021 — Longboard Revision Hip Stem (August 7, 2025)
  • K251906 — Z1 Hip System (July 18, 2025)
  • K251292 — RECLAIM Monobloc Revision Femoral Stem (May 23, 2025)
  • K243927 — MobileLink Acetabular Cup System - inhouse coatings (May 16, 2025)
  • K250444 — NEXUS® Hip Stem (May 15, 2025)
  • K243043 — Origin™ Cemented Hip Stem (May 2, 2025)
  • K250834 — Zimmer Biomet Ceramic Heads (22.2mm diameter) (April 18, 2025)