Cleared Traditional

RESORBABLE HAMMERTOE PIN (K011137) - FDA 510(k) Clearance

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

K011137 · Biomet, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2001
Decision
67d
Days
Class 2
Risk

K011137 is an FDA 510(k) clearance for the RESORBABLE HAMMERTOE PIN. 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 June 19, 2001 after a review of 67 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. 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 K011137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2001
Decision Date June 19, 2001
Days to Decision 67 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
55d faster than avg
Panel avg: 122d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K011137.
JET-X HA COATED HALF PINS
K023921 · Smith & Nephew, Inc. · Feb 2003
JET-X TIN COATED HALF PINS
K023134 · Smith & Nephew, Inc. · Oct 2002
RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR
K021182 · Biomet, Inc. · May 2002
APEX FIXATION PINS
K011136 · Howmedica Osteonics Corp. · May 2001
4.0/2.5 MM SELF-DRILLING SCHANZ SCREW
K002605 · Synthes (Usa) · Nov 2000
BIOMET LATERAL TROCH PLATE
K003294 · Biomet, Inc. · Nov 2000