Cleared Traditional

K002644 - RADIAL HEAD IMPLANT

K002644 is an FDA 510(k) clearance for RADIAL HEAD IMPLANT, manufactured by Avanta Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code KWI cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K002644 · Avanta Orthopaedics, Inc. · Orthopedic device
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Nov 2000
Decision
88d
Days
Class 2
Risk

K002644 is an FDA 510(k) clearance for the RADIAL HEAD IMPLANT. Classified as Prosthesis, Elbow, Hemi-, Radial, Polymer (product code KWI), Class II - Special Controls.

Submitted by Avanta Orthopaedics, Inc. (San Diego, US). The FDA issued a Cleared decision on November 20, 2000 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Avanta Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K002644

510(k) Number K002644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2000
Decision Date November 20, 2000
Days to Decision 88 days
Submission Type Traditional
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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWI Device Classification - Class 2, Special Controls

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 29
Devices cleared under the same product code (KWI) and FDA review panel - the closest regulatory comparables to K002644.
MODIFICATION TO RADIAL HEAD IMPLANT
K023604 · Avanta Orthopaedics, Inc. · Nov 2002
LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE
K012551 · Biomet, Inc. · Jan 2002
RADIAL HEAD IMPLANT
K011819 · Avanta Orthopaedics, Inc. · Jun 2001
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