Cleared Traditional

K894298 - MODIFIED GEMINI ACETABULAR CUP

K894298 is an FDA 510(k) clearance for MODIFIED GEMINI ACETABULAR CUP, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K894298 · Depuy, Inc. · Orthopedic device
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Sep 1989
Decision
97d
Days
Class 2
Risk

K894298 is an FDA 510(k) clearance for the MODIFIED GEMINI ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 27, 1989 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Depuy, Inc. devices

FDA 510(k) Submission Details - K894298

510(k) Number K894298 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 22, 1989
Decision Date September 27, 1989
Days to Decision 97 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 516
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K894298.
LORD L.F.R. TOTAL HIP SYSTEM
K884890 · Howmedica Corp. · Dec 1989
ACETABULAR SHELLS & LINERS FOR ATH TOTAL HIP SYST.
K893821 · Kinamed, Inc. · Nov 1989
FREEMAN MODULAR HIP STEM RIDGED VERSION
K890498 · Orthopedic Systems, Inc. · Oct 1989
MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL
K894149 · Howmedica Corp. · Sep 1989
MOD. FEMORAL COMP. NON-BEADED & BASIC ACE. SHELL
K894148 · Howmedica Corp. · Sep 1989
UNIVERSAL CEMENTED CUP
K894249 · Orthopedic Systems, Inc. · Aug 1989