Cleared Traditional

K831373 - P.C.A. HIP SYSTEM

K831373 is the FDA 510(k) clearance for P.C.A. HIP SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K831373 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1983
Decision
121d
Days
Class 2
Risk

K831373 is an FDA 510(k) clearance for the P.C.A. HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on August 26, 1983 after a review of 121 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 Howmedica Corp. devices

Submission Details

510(k) Number K831373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1983
Decision Date August 26, 1983
Days to Decision 121 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
1d faster than avg
Panel avg: 122d · This submission: 121d
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 435
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K831373.
FREEMAN ACETABULAR CUP
K832958 · Depuy, Inc. · Oct 1983
MMS ACETABULAR CUPS
K830361 · 3M Company · Sep 1983
DOSIMETRIC RELEASE OF GAMMA RADIATION
K832211 · Kirschner Medical Corp. · Sep 1983
METAL-BACKED ACE TABULAR CUP
K831986 · Kirschner Medical Corp. · Aug 1983
INTERFERENCE MEDULLARY FIT -IMF-HIP
K831314 · Depuy, Inc. · Jul 1983
MILWAUKEE AUSTIN MOORE TOTAL HIP
K830314 · Biomet, Inc. · Jun 1983