Cleared Traditional

K944507 - METALLIC RADIAL HEAD IMPLANTS (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K944507 · Wrightmedicaltechnologyinc · Orthopedic device
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Jul 1995
Decision
301d
Days
Class 2
Risk

K944507 is an FDA 510(k) clearance for the METALLIC RADIAL HEAD IMPLANTS. Classified as Prosthesis, Elbow, Hemi-, Radial, Polymer (product code KWI), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on July 13, 1995 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3170 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K944507 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 15, 1994
Decision Date July 13, 1995
Days to Decision 301 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 122d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3170
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.