Home / 510(k) Clearances / K953033

510(k) K953033

PRIME CEMENTED SMALL FEMORAL STEM by Orthopaedic Innovations, Inc. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1995
Date Received
June 30, 1995
Clearance Type
Traditional
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 Orthopaedic Innovations, Inc.

  • K020145 — ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM (April 15, 2002)
  • K983881 — COBRA EXTERNAL FIXATOR (December 4, 1998)
  • K962646 — PRIME MODULAR ENDO HEAD (September 23, 1996)
  • K960014 — PRACTIFIX EXTERNAL FIXATION SYSTEM (March 18, 1996)
  • K955620 — PRIME CEMENTED CALCAR FEMORAL STEMS (February 20, 1996)
  • K955751 — PRIME FEMORAL CEMENT PLUG (January 26, 1996)
  • K940328 — PRIME CEMENTED HIP SYSTEM (April 7, 1995)

Other clearances for product code JDI

  • K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained L (July 31, 2025)
  • K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectr (October 21, 2024)
  • K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (August 2, 2024)
  • 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)