Cleared Special

K043537 - TAPERLOC 12/14 TAPER FEMORAL COMPONENTS

K043537 is an FDA 510(k) clearance for TAPERLOC 12/14 TAPER FEMORAL COMPONENTS, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Special 510(k) pathway after a 23-day FDA review.

K043537 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
23d
Days
Class 2
Risk

K043537 is an FDA 510(k) clearance for the TAPERLOC 12/14 TAPER FEMORAL COMPONENTS. 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 January 14, 2005 after a review of 23 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

FDA 510(k) Submission Details - K043537

510(k) Number K043537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2004
Decision Date January 14, 2005
Days to Decision 23 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
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

LPH Device Classification - Class 2, Special Controls

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 543
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K043537.
TRIDENT ACETABULAR SYSTEM
K033716 · Howmedica Osteonics Corp. · Feb 2005
APEX MODULAR HA HIP STEM
K043123 · Apex Surgical, LLC · Feb 2005
MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS
K042774 · Biomet, Inc. · Jan 2005
MEDALLION MODULAR HIP SYSTEM
K041850 · Biomet Manufacturing, Inc. · Dec 2004
APEX K2 HIP SYSTEM
K041950 · Apex Surgical, LLC · Dec 2004
TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3
K042871 · Zimmer Trabecular · Dec 2004