Cleared Traditional

K934060 - HOWMEDICA ACETABULAR COMP PACK/MANUF ME...

K934060 is the FDA 510(k) clearance for HOWMEDICA ACETABULAR COMP PACK/MANUF ME... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 729-day FDA review.

K934060 · Howmedica Corp. · Orthopedic device
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Aug 1995
Decision
729d
Days
Class 2
Risk

K934060 is an FDA 510(k) clearance for the HOWMEDICA(R) ACETABULAR COMP PACK/MANUF METH CHANGE. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on August 18, 1995 after a review of 729 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 K934060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1993
Decision Date August 18, 1995
Days to Decision 729 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
607d slower than avg
Panel avg: 122d · This submission: 729d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 428
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