Cleared Special

K021911 - TRIDENT CROSSFIRE POLYUETHYLENE LINERS

K021911 is an FDA 510(k) clearance for TRIDENT CROSSFIRE POLYUETHYLENE LINERS, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Special 510(k) pathway after a 21-day FDA review.

K021911 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
21d
Days
Class 2
Risk

K021911 is an FDA 510(k) clearance for the TRIDENT CROSSFIRE POLYUETHYLENE LINERS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on July 2, 2002 after a review of 21 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.

FDA 510(k) Submission Details - K021911

510(k) Number K021911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2002
Decision Date July 02, 2002
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
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 564
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K021911.
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K021911 · TRIDENT CROSSFIRE POLYUETHYLENE LINERS
Download PDF FDA Summary Howmedica Osteonics C…