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510(k) K143407

Klassic HD Hip System by Total Joint Othopedics, Inc. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2014
Date Received
November 28, 2014
Clearance Type
Special
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 Total Joint Othopedics, Inc.

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  • K213580 — Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length (December 3, 2021)
  • K191399 — BIOLOX CONTOURA Ceramic Femoral Head (August 28, 2019)
  • K171962 — Klassic HD® Hip System (July 24, 2017)
  • K161073 — Klassic HD Hip System (October 19, 2016)

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  • K251906 — Z1 Hip System (July 18, 2025)
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  • K250834 — Zimmer Biomet Ceramic Heads (22.2mm diameter) (April 18, 2025)