Cleared Traditional

INTERFERENCE MEDULLARY FIT -IMF-HIP (K831314) - FDA 510(k) Clearance

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

K831314 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1983
Decision
81d
Days
Class 2
Risk

K831314 is an FDA 510(k) clearance for the INTERFERENCE MEDULLARY FIT -IMF-HIP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Depuy, Inc. (Walker, US). The FDA issued a Cleared decision on July 12, 1983 after a review of 81 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 K831314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1983
Decision Date July 12, 1983
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
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 K831314.
FREEMAN ACETABULAR CUP
K832958 · Depuy, Inc. · Oct 1983
MMS ACETABULAR CUPS
K830361 · 3M Company · Sep 1983
P.C.A. HIP SYSTEM
K831373 · Howmedica Corp. · Aug 1983
MILWAUKEE AUSTIN MOORE TOTAL HIP
K830314 · Biomet, Inc. · Jun 1983
CFE TOTAL HIP FEMORAL COMPONENT
K830313 · Biomet, Inc. · May 1983
LUS ACETABULAR COMPONENT
K830209 · Biomet, Inc. · May 1983