Cleared Traditional

K001385 - HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS

K001385 is an FDA 510(k) clearance for HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code KWI cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K001385 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
86d
Days
Class 2
Risk

K001385 is an FDA 510(k) clearance for the HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS. Classified as Prosthesis, Elbow, Hemi-, Radial, Polymer (product code KWI), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Rutherford, US). The FDA issued a Cleared decision on July 27, 2000 after a review of 86 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 Howmedica Osteonics Corp. devices

FDA 510(k) Submission Details - K001385

510(k) Number K001385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2000
Decision Date July 27, 2000
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
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 K001385.
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
ERS RADIAL HEAD REPLACEMENT
K000658 · DePuy Orthopaedics, Inc. · May 2000
RADIAL HEAD PROSTHESIS
K992220 · Smith & Nephew, Inc. · Feb 2000
MODULAR RADIAL HEAD
K991915 · Wrightmedicaltechnologyinc · Sep 1999