Cleared Special

K000538 - MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL

K000538 is the FDA 510(k) clearance for MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL by Biomet, Inc.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Special 510(k) pathway after a 27-day FDA review.

K000538 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
27d
Days
Class 2
Risk

K000538 is an FDA 510(k) clearance for the MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 15, 2000 after a review of 27 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. 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 Biomet, Inc. devices

Submission Details

510(k) Number K000538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2000
Decision Date March 15, 2000
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 446
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K000538.
HEMISPHERE MODULAR CUP SYSTEM
K000321 · Ortho Development Corp. · Apr 2000
BICON-PLUS ACETABULAR COMPONENTS
K992154 · Plus Orthopedics · Apr 2000
PINNACLE ACETABULAR SYSTEM
K000306 · DePuy Orthopaedics, Inc. · Mar 2000
INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS
K993259 · Sulzer Orthopedics, Inc. · Mar 2000
ZMR HIP SYSTEM-POROUS REVISION
K994286 · Zimmer, Inc. · Mar 2000
MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM
K000335 · Biomet, Inc. · Feb 2000