Cleared Special

K050556 - ALUMINA HEAD

K050556 is an FDA 510(k) clearance for ALUMINA HEAD, manufactured by Fournitures Hospitalieres Industrie. The device is a Class 2 Orthopedic device with product code LZO cleared through the Special 510(k) pathway after a 69-day FDA review.

K050556 · Fournitures Hospitalieres Industrie · Orthopedic device
Download Printable Device Report (PDF)
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May 2005
Decision
69d
Days
Class 2
Risk

K050556 is an FDA 510(k) clearance for the ALUMINA HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Fournitures Hospitalieres Industrie (Quimper Finistere, FR). The FDA issued a Cleared decision on May 11, 2005 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fournitures Hospitalieres Industrie devices

FDA 510(k) Submission Details - K050556

510(k) Number K050556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2005
Decision Date May 11, 2005
Days to Decision 69 days
Submission Type Special
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
53d faster than avg
Panel avg: 122d · This submission: 69d
Pathway characteristics
Modification to existing cleared device.

LZO Device Classification - Class 2, Special Controls

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 451
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K050556.
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K041940 · Howmedica Osteonics Corp. · Feb 2005
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K042992 · DePuy Orthopaedics, Inc. · Feb 2005