Cleared Traditional

K953664 - VITALOCK SPIKED ACETABULAR SHELL

K953664 is the FDA 510(k) clearance for VITALOCK SPIKED ACETABULAR SHELL by Howmedica Corp.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K953664 · Howmedica Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 1995
Decision
77d
Days
Class 2
Risk

K953664 is an FDA 510(k) clearance for the VITALOCK SPIKED ACETABULAR SHELL. 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 October 23, 1995 after a review of 77 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Howmedica Corp. devices

Submission Details

510(k) Number K953664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1995
Decision Date October 23, 1995
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K953664.
A-B ACETABULAR COMPONENT
K954417 · Biomet, Inc. · Dec 1995
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EXTEND HIP SYSTEM
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K953490 · Zimmer, Inc. · Oct 1995
HOWMEDICA(R) ACETABULAR COMP PACK/MANUF METH CHANGE
K934060 · Howmedica Corp. · Aug 1995
PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS
K936292 · Howmedica Corp. · Aug 1995