Cleared Traditional

NEW JERSEY MODULAR FEMORAL HIP (K853655) - FDA 510(k) Clearance

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

K853655 · Depuy, Inc. · Orthopedic device
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Sep 1985
Decision
16d
Days
Class 2
Risk

K853655 is an FDA 510(k) clearance for the NEW JERSEY MODULAR FEMORAL HIP. 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 19, 1985 after a review of 16 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Depuy, Inc. devices

Submission Details

510(k) Number K853655 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 03, 1985
Decision Date September 19, 1985
Days to Decision 16 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
106d faster than avg
Panel avg: 122d · This submission: 16d
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 K853655.
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
POROUS APF/MODULAR FEMORAL COMPONENT
K852585 · Biomet, Inc. · Aug 1985
HOWMEDICA CEMENTED FLANGED ACETABULAR COMPONENT SY
K852546 · Howmedica Corp. · Aug 1985
THE P.C.A. TWO-PIECE SNAP LOCK ACETABULAR CUP
K852153 · Howmedica Corp. · Aug 1985