Cleared Abbreviated

K992220 - RADIAL HEAD PROSTHESIS

K992220 is the FDA 510(k) clearance for RADIAL HEAD PROSTHESIS by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code KWI) cleared through the Abbreviated 510(k) pathway after a 239-day FDA review.

K992220 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
239d
Days
Class 2
Risk

K992220 is an FDA 510(k) clearance for the RADIAL HEAD PROSTHESIS. Classified as Prosthesis, Elbow, Hemi-, Radial, Polymer (product code KWI), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on February 25, 2000 after a review of 239 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3170 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K992220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1999
Decision Date February 25, 2000
Days to Decision 239 days
Submission Type Abbreviated
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
117d slower than avg
Panel avg: 122d · This submission: 239d
Pathway characteristics
Standards-based clearance path.

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.

Regulatory Peers - KWI Prosthesis, Elbow, Hemi-, Radial, Polymer

All 20
Devices cleared under the same product code (KWI) and FDA review panel - the closest regulatory comparables to K992220.
TORNIER BIPOLAR RADIAL HEAD PROSTHESIS
K994041 · Tornier, Inc. · Aug 2000
HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS
K001385 · Howmedica Osteonics Corp. · Jul 2000
ERS RADIAL HEAD REPLACEMENT
K000658 · DePuy Orthopaedics, Inc. · May 2000
MODULAR RADIAL HEAD
K991915 · Wrightmedicaltechnologyinc · Sep 1999
IMPLEX RADIAL HEAD REPLACEMENT SYSTEM
K984290 · Implex Corp. · Jun 1999
METALLIC RADIAL HEAD IMPLANTS
K944507 · Wrightmedicaltechnologyinc · Jul 1995