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510(k) K260831

Z1 Hip System by Zimmer, Inc. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2026
Date Received
March 13, 2026
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 Zimmer, Inc.

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  • K253566 — Affixus Retrograde Femoral Nailing System (March 12, 2026)
  • K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) (March 9, 2026)
  • K252623 — G7® Revision Acetabular System (February 4, 2026)
  • K251098 — Identity Revision Humeral Stems (August 11, 2025)
  • K251906 — Z1 Hip System (July 18, 2025)
  • K250848 — Identity Shoulder System (July 2, 2025)

Other clearances for product code LZO

  • K260182 — Avenir® Müller Stem; Avenir Complete™ Hip System (April 27, 2026)
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  • K252401 — implaFit® short stems (March 12, 2026)
  • K253171 — Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) (January 15, 2026)
  • 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)