Cleared Traditional

MILWAUKEE AUSTIN MOORE TOTAL HIP (K830314) - FDA 510(k) Clearance

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

K830314 · Biomet, Inc. · Orthopedic device
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Jun 1983
Decision
144d
Days
Class 2
Risk

K830314 is an FDA 510(k) clearance for the MILWAUKEE AUSTIN MOORE TOTAL HIP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1983 after a review of 144 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 Biomet, Inc. devices

Submission Details

510(k) Number K830314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1983
Decision Date June 24, 1983
Days to Decision 144 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
22d slower than avg
Panel avg: 122d · This submission: 144d
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 K830314.
MMS ACETABULAR CUPS
K830361 · 3M Company · Sep 1983
P.C.A. HIP SYSTEM
K831373 · Howmedica Corp. · Aug 1983
INTERFERENCE MEDULLARY FIT -IMF-HIP
K831314 · Depuy, Inc. · Jul 1983
CFE TOTAL HIP FEMORAL COMPONENT
K830313 · Biomet, Inc. · May 1983
LUS ACETABULAR COMPONENT
K830209 · Biomet, Inc. · May 1983
HARRIS A.R. C. ACETABULAR CUP
K830857 · Howmedica Corp. · May 1983