Cleared Traditional

C.L.E. ACETABULAR CUP

K870922 · Protek, Inc. · Orthopedic
Oct 1987
Decision
239d
Days
Class 2
Risk

About This 510(k) Submission

K870922 is an FDA 510(k) clearance for the C.L.E. ACETABULAR CUP, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on October 28, 1987, 239 days after receiving the submission on March 3, 1987. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K870922 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1987
Decision Date October 28, 1987
Days to Decision 239 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3350

Similar Devices — JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 561
Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners
K243571 · Zimmer Biomet · Jul 2025
Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
K240783 · Smith & Nephew, Inc. · Oct 2024
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
K241716 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Aug 2024
Stryker Orthopaedics Hip Systems Labeling Update
K240418 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Apr 2024
Global Modular Replacement System
K233261 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Dec 2023
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
K222056 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Jan 2023