Cleared Traditional

K930460 - HOWMEDICA REVISION HIP SYSTEM

K930460 is the FDA 510(k) clearance for HOWMEDICA REVISION HIP SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 390-day FDA review.

K930460 · Howmedica Corp. · Orthopedic device
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Feb 1994
Decision
390d
Days
Class 2
Risk

K930460 is an FDA 510(k) clearance for the HOWMEDICA REVISION HIP SYSTEM. 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 390 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 K930460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1993
Decision Date February 22, 1994
Days to Decision 390 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
268d slower than avg
Panel avg: 122d · This submission: 390d
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 K930460.
PRECISION OSTEOFLEX FEMORAL COMPONENT
K903630 · Howmedica Corp. · Feb 1994
APC FEMORAL COMPONENT
K926229 · Howmedica Corp. · Feb 1994
HOWMEDICA ACETABULAR SHELL
K930223 · Howmedica Corp. · Feb 1994
PERFECTA TOTAL HIP SYSTEM
K923243 · Orthomet, Inc. · Jan 1994
APR FEMORAL HIP COMPONENT
K930812 · Intermedics Orthopedics · Nov 1993
RMHS POROUS DISTAL SLEEVE
K930108 · Smith & Nephew Richards, Inc. · Sep 1993