Cleared Special

K992570 - UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K992570 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
30d
Days
Class 2
Risk

K992570 is an FDA 510(k) clearance for the UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on September 1, 1999 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K992570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1999
Decision Date September 01, 1999
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 105
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