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510(k) K021661

RINGLOC CONSTRAINED LINERS by Biomet Orthopedics, Inc. — Product Code KWZ

K021661 is an FDA 510(k) premarket notification submitted by Biomet Orthopedics, Inc. for the device "RINGLOC CONSTRAINED LINERS". The FDA issued a decision of Substantially Equivalent on October 25, 2002. 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. Biomet Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2002
Date Received
May 20, 2002
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 Biomet Orthopedics, Inc.

  • K252404 — Comprehensive Reverse Shoulder - HA Glenosphere Baseplates (April 15, 2026)
  • K243761 — A.L.P.S. Small Fragment Plating System (February 19, 2025)
  • K223631 — Comprehensive Segmental Revision System(SRS) (July 12, 2023)
  • K200196 — Taperloc® Complete Hip Stems (December 8, 2020)
  • K131393 — MAK OSS FEMORAL KNEE COMPONENTS (October 24, 2013)
  • K112905 — COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM (May 24, 2012)
  • K080528 — E-POLY TIBIAL BEARINGS (June 17, 2008)
  • K072879 — INNERVUE DIAGNOSTIC SCOPE SYSTEM (January 14, 2008)
  • K070955 — ACID ETCHED LAG SCREWS (October 12, 2007)
  • K033355 — LACTOSCREW SCREW ANCHOR (June 30, 2004)

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