Cleared Traditional

K012551 - LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE

K012551 is an FDA 510(k) clearance for LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code KWI cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K012551 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
176d
Days
Class 2
Risk

K012551 is an FDA 510(k) clearance for the LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE. Classified as Prosthesis, Elbow, Hemi-, Radial, Polymer (product code KWI), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 30, 2002 after a review of 176 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 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet, Inc. devices

FDA 510(k) Submission Details - K012551

510(k) Number K012551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2001
Decision Date January 30, 2002
Days to Decision 176 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
54d slower than avg
Panel avg: 122d · This submission: 176d
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 31
Devices cleared under the same product code (KWI) and FDA review panel - the closest regulatory comparables to K012551.
ASCENSION MODULAR RADIAL HEAD
K032686 · Ascension Orthopedics, Inc. · Oct 2003
EVOLVE CERAMIC RADIAL HEAD IMPLANT
K030384 · Wrightmedicaltechnologyinc · Aug 2003
MODIFICATION TO RADIAL HEAD IMPLANT
K023604 · Avanta Orthopaedics, Inc. · Nov 2002
RADIAL HEAD IMPLANT
K011819 · Avanta Orthopaedics, Inc. · Jun 2001
RADIAL HEAD IMPLANT
K002644 · Avanta Orthopaedics, Inc. · Nov 2000
TORNIER BIPOLAR RADIAL HEAD PROSTHESIS
K994041 · Tornier, Inc. · Aug 2000