Cleared Traditional

K930223 - HOWMEDICA ACETABULAR SHELL

K930223 is the FDA 510(k) clearance for HOWMEDICA ACETABULAR SHELL by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 403-day FDA review.

K930223 · Howmedica Corp. · Orthopedic device
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Feb 1994
Decision
403d
Days
Class 2
Risk

K930223 is an FDA 510(k) clearance for the HOWMEDICA ACETABULAR SHELL. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 403 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Howmedica Corp. devices

Submission Details

510(k) Number K930223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1993
Decision Date February 22, 1994
Days to Decision 403 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
281d slower than avg
Panel avg: 122d · This submission: 403d
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 K930223.
PREMISE CEMENTED FEMORAL STEM, ADDITION STYLE
K933875 · Howmedica Corp. · Mar 1994
PRECISION OSTEOFLEX FEMORAL COMPONENT
K903630 · Howmedica Corp. · Feb 1994
APC FEMORAL COMPONENT
K926229 · Howmedica Corp. · Feb 1994
HOWMEDICA REVISION HIP SYSTEM
K930460 · Howmedica Corp. · Feb 1994
PERFECTA TOTAL HIP SYSTEM
K923243 · Orthomet, Inc. · Jan 1994
APR FEMORAL HIP COMPONENT
K930812 · Intermedics Orthopedics · Nov 1993