Home / 510(k) Clearances / K061681

510(k) K061681

REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT by Biomet Manufacturing Corp — Product Code HRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2006
Date Received
June 15, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3530
Review Panel
OR
Submission Type

Other clearances by Biomet Manufacturing Corp

  • K230540 — Patient Specific Planning Solution™ 3D Bone Models (July 25, 2023)
  • K214001 — Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System (March 15, 2023)
  • K211729 — Comprehensive® Convertible Glenoid - Vivacit-E Liner (November 4, 2021)
  • K202232 — Comprehensive Vault Reconstruction System (February 19, 2021)
  • K193038 — Comprehensive Shoulder System (October 28, 2020)
  • K182516 — Comprehensive Nano Stemless Shoulder (April 22, 2019)
  • K181611 — Comprehensive Reverse Shoulder System (September 24, 2018)
  • K173411 — Comprehensive Segmental Revision System (SRS) (February 8, 2018)
  • K172502 — Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Co (January 3, 2018)
  • K163651 — ExpressBraid Graft Manipulation (February 17, 2017)

Other clearances for product code HRY

  • K193549 — SIGMA High Performance (HP) Partial Knee System (April 16, 2020)
  • K190633 — NanoOrtho NanoKnee® System (December 20, 2019)
  • K152631 — MPO Total Knee Systems MR Labeling (March 23, 2016)
  • K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM (March 20, 2015)
  • K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) (March 28, 2014)
  • K131167 — UNIVATION (October 17, 2013)
  • K122277 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) (October 22, 2012)
  • K110415 — SIGNATURE PLANNER / SIGNATURE GUIDES (May 16, 2011)
  • K100973 — EVOLUTION UNICONDYLAR KNEE SYSTEM (August 10, 2010)
  • K082567 — STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION (October 3, 2008)