Cleared Abbreviated

RADIAL HEAD PROSTHESIS (K992220) - FDA 510(k) Clearance

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

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 32
Devices cleared under the same product code (KWI) and FDA review panel - the closest regulatory comparables to K992220.
BioPoly Radial Head Implant
K233592 · BioPoly, LLC · Mar 2024
ALIGN Radial Head System
K231188 · Skeletal Dynamics, Inc. · Sep 2023
DePuy Synthes Radial Head Replacement System
K213563 · DePuy Synthes · Mar 2022
Avenger Radial Head System
K212872 · In2bones USA, LLC · Dec 2021
Avenger Radial Head System
K192754 · In2bones USA, LLC · Jan 2020
Revolution Radial Head
K183618 · Ignite Orthopedics, Inc. · May 2019