Cleared Special

K050937 - TRABECULAR METAL ACETABULAR REVISION SHELLS

K050937 is an FDA 510(k) clearance for TRABECULAR METAL ACETABULAR REVISION SHELLS, manufactured by Zimmer Trabecular. The device is a Class 2 Orthopedic device with product code LPH cleared through the Special 510(k) pathway after a 27-day FDA review.

K050937 · Zimmer Trabecular · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
27d
Days
Class 2
Risk

K050937 is an FDA 510(k) clearance for the TRABECULAR METAL ACETABULAR REVISION SHELLS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Zimmer Trabecular (Allendale, US). The FDA issued a Cleared decision on May 11, 2005 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 Zimmer Trabecular devices

FDA 510(k) Submission Details - K050937

510(k) Number K050937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2005
Decision Date May 11, 2005
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 122d · This submission: 27d
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 504
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K050937.
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K042051 · Biomet, Inc. · Mar 2005