Cleared Traditional

ERS RADIAL HEAD REPLACEMENT (K000658) - FDA 510(k) Clearance

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

K000658 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
73d
Days
Class 2
Risk

K000658 is an FDA 510(k) clearance for the ERS RADIAL HEAD REPLACEMENT. Classified as Prosthesis, Elbow, Hemi-, Radial, Polymer (product code KWI), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 11, 2000 after a review of 73 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 DePuy Orthopaedics, Inc. devices

Submission Details

510(k) Number K000658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2000
Decision Date May 11, 2000
Days to Decision 73 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
49d faster than avg
Panel avg: 122d · This submission: 73d
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.

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

All 15
Devices cleared under the same product code (KWI) and FDA review panel - the closest regulatory comparables to K000658.
EVOLVE CERAMIC RADIAL HEAD IMPLANT
K030384 · Wrightmedicaltechnologyinc · Aug 2003
LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE
K012551 · Biomet, Inc. · Jan 2002
HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS
K001385 · Howmedica Osteonics Corp. · Jul 2000
RADIAL HEAD PROSTHESIS
K992220 · Smith & Nephew, Inc. · Feb 2000
MODULAR RADIAL HEAD
K991915 · Wrightmedicaltechnologyinc · Sep 1999
METALLIC RADIAL HEAD IMPLANTS
K944507 · Wrightmedicaltechnologyinc · Jul 1995