Cleared Special

RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR (K021182) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K021182 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
28d
Days
Class 2
Risk

K021182 is an FDA 510(k) clearance for the RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 13, 2002 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biomet, Inc. devices

Submission Details

510(k) Number K021182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2002
Decision Date May 13, 2002
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JDW Pin, Fixation, Threaded
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - JDW Pin, Fixation, Threaded

All 37
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K021182.
MODIFICATION TO JET-X HA COATED HALF PINS
K033289 · Smith & Nephew, Inc. · Jan 2004
JET-X HA COATED HALF PINS
K023921 · Smith & Nephew, Inc. · Feb 2003
JET-X TIN COATED HALF PINS
K023134 · Smith & Nephew, Inc. · Oct 2002
RESORBABLE HAMMERTOE PIN
K011137 · Biomet, Inc. · Jun 2001
APEX FIXATION PINS
K011136 · Howmedica Osteonics Corp. · May 2001
4.0/2.5 MM SELF-DRILLING SCHANZ SCREW
K002605 · Synthes (Usa) · Nov 2000