Cleared Traditional

MODIFIED GEMINI ACETABULAR CUP (K894298) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K894298.
TITANIUM MODULAR MODULAR COLLARLESS HIP
K895036 · Depuy, Inc. · Jan 1990
QUANTUM HIP STEM
K896325 · Depuy, Inc. · Jan 1990
LORD L.F.R. TOTAL HIP SYSTEM
K884890 · Howmedica Corp. · Dec 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
EXETER II TOTAL HIP SYSTEM
K891454 · Howmedica Corp. · Jun 1989