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510(k) K012961

SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM by Sulzer Orthopedics, Inc. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2001
Date Received
September 4, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

Other clearances by Sulzer Orthopedics, Inc.

  • K022985 — ASCENDENT ACETABULAR SYSTEM (December 5, 2002)
  • K021578 — NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE (August 9, 2002)
  • K020713 — MS-30 LATERAL FEMORAL STEM (May 14, 2002)
  • K013935 — ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS (December 13, 2001)
  • K013031 — MOST OPTIONS SYSTEM (December 7, 2001)
  • K012739 — CONVERGE ACETABULAR SYSTEM (November 14, 2001)
  • K011954 — SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE (September 19, 2001)
  • K010839 — CLS VARUS STEM/CLS 135 STEM (April 18, 2001)
  • K003758 — ALLOFIT ACETABULAR SYSTEM (March 7, 2001)
  • K003801 — ANATOMICAL PRESS-FIT HUMERAL STEM (February 28, 2001)

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  • K240418 — Stryker Orthopaedics Hip Systems Labeling Update (April 12, 2024)
  • K233261 — Global Modular Replacement System (December 8, 2023)
  • K222056 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (January 26, 2023)
  • K220216 — C-Stem AMT LE Prosthesis (July 22, 2022)
  • K213701 — Exeter® X3® RimFit® Cup (February 1, 2022)
  • K213816 — MPO Hip Instruments (January 5, 2022)
  • K210842 — VerSys Cemented Revision/Calcar (December 10, 2021)