Cleared Traditional

K051385 - EXPLOR MODULAR RADIAL HEAD REPLACEMENT ...

K051385 is the FDA 510(k) clearance for EXPLOR MODULAR RADIAL HEAD REPLACEMENT ... by Biomet, Inc.. It is a Class 2 Orthopedic device (product code KWI) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K051385 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
70d
Days
Class 2
Risk

K051385 is an FDA 510(k) clearance for the EXPLOR MODULAR 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 August 5, 2005 after a review of 70 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 Biomet, Inc. devices

Submission Details

510(k) Number K051385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2005
Decision Date August 05, 2005
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
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 20
Devices cleared under the same product code (KWI) and FDA review panel - the closest regulatory comparables to K051385.
Revolution Radial Head
K183618 · Ignite Orthopedics, Inc. · May 2019
ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC
K131845 · Acumed, LLC · Sep 2013
EVOLVE MODULAR RADIAL HEAD
K060731 · Wrightmedicaltechnologyinc · Apr 2006
ACUMED ANATOMIC RADIAL HEAD SYSTEM
K041858 · Acumed, LLC · Oct 2004
MODULAR RADIAL HEAD REPLACEMENT DEVICE
K040611 · Biomet, Inc. · Jun 2004
EVOLVE CERAMIC RADIAL HEAD IMPLANT
K030384 · Wrightmedicaltechnologyinc · Aug 2003