Cleared Traditional

GT HIP PROSTHESIS FEMORAL COMPONENT (K853169) - FDA 510(k) Clearance

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

K853169 · Intermedics Orthopedics · Orthopedic device
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Oct 1985
Decision
91d
Days
Class 2
Risk

K853169 is an FDA 510(k) clearance for the GT HIP PROSTHESIS FEMORAL COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on October 29, 1985 after a review of 91 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 Intermedics Orthopedics devices

Submission Details

510(k) Number K853169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1985
Decision Date October 29, 1985
Days to Decision 91 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 122d · This submission: 91d
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 280
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K853169.
HPS II SMOOTH STEM
K860701 · Depuy, Inc. · Mar 1986
P.C.A. UNIVERSAL ACETABULAR COMPONENT SYSTEM
K853886 · Howmedica Corp. · Nov 1985
COLLAR LESS AML HIP
K853408 · Depuy, Inc. · Nov 1985
NEW JERSEY MODULAR FEMORAL HIP
K853655 · Depuy, Inc. · Sep 1985
POROUS APF/MODULAR FEMORAL COMPONENT
K852585 · Biomet, Inc. · Aug 1985
HOWMEDICA CEMENTED FLANGED ACETABULAR COMPONENT SY
K852546 · Howmedica Corp. · Aug 1985