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510(k) K043058

PINNACLE CONSTRAINED ACETABULAR LINERS by Depuy, Inc. — Product Code KWZ

K043058 is an FDA 510(k) premarket notification submitted by Depuy, Inc. for the device "PINNACLE CONSTRAINED ACETABULAR LINERS". The FDA issued a decision of Substantially Equivalent on March 14, 2005. The device falls under product code KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3310. Depuy, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2005
Date Received
November 5, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3310
Review Panel
OR
Submission Type

Other clearances by Depuy, Inc.

  • K042664 — LPS UPPER EXTREMITY (December 8, 2004)
  • K041085 — LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY (July 22, 2004)
  • K033959 — LPS (July 1, 2004)
  • K040544 — DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO (May 28, 2004)
  • K021478 — DELTA SHOULDER (November 18, 2003)
  • K033329 — DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS (November 14, 2003)
  • K032151 — DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS (September 26, 2003)
  • K020541 — AGILITY ANKLE REVISION PROSTHESIS (May 20, 2002)
  • K011810 — ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING (September 7, 2001)
  • K003182 — ORTHOGENESIS LPS SYSTEM (June 27, 2001)

Other clearances for product code KWZ

  • K241461 — Mpact Constrained Liner (July 31, 2025)
  • K240639 — PINNACLETM Constrained Acetabular Liners (April 4, 2024)
  • K162641 — Smith & Nephew, Inc. R3™ Constrained Liner (June 19, 2017)
  • K163497 — EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset (March 2, 2017)
  • K161610 — EXPRT Revision Hip System (November 9, 2016)
  • K122139 — SMITH & NEPHEW R3 CONSTRAINED LINERS (October 16, 2012)
  • K111635 — SMITH & NEPHEW RJ CONSTRAINED LINERS (September 9, 2011)
  • K101730 — LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS (December 3, 2010)
  • K083566 — R3 CONSTRAINED LINER, CONSTRAINED LINER (March 3, 2009)
  • K072121 — TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER (January 7, 2008)

FDA data resources