Cleared Traditional

MMS ACETABULAR CUPS (K830361) - FDA 510(k) Clearance

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

K830361 · 3M Company · Orthopedic device
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Sep 1983
Decision
238d
Days
Class 2
Risk

K830361 is an FDA 510(k) clearance for the MMS ACETABULAR CUPS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 238 days - an extended review 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: 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 3M Company devices

Submission Details

510(k) Number K830361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1983
Decision Date September 29, 1983
Days to Decision 238 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
116d slower than avg
Panel avg: 122d · This submission: 238d
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 K830361.
HARRIS-GALANTE POROUS TOTAL HIP SYS
K840643 · Zimmer, Inc. · Apr 1984
GALANTE FIBER METAL TOTAL HIP
K833912 · Zimmer, Inc. · Dec 1983
FREEMAN ACETABULAR CUP
K832958 · Depuy, Inc. · Oct 1983
P.C.A. HIP SYSTEM
K831373 · Howmedica Corp. · Aug 1983
INTERFERENCE MEDULLARY FIT -IMF-HIP
K831314 · Depuy, Inc. · Jul 1983
MILWAUKEE AUSTIN MOORE TOTAL HIP
K830314 · Biomet, Inc. · Jun 1983