Cleared Traditional

K011137 - RESORBABLE HAMMERTOE PIN

K011137 is the FDA 510(k) clearance for RESORBABLE HAMMERTOE PIN by Biomet, Inc.. It is a Class 2 Orthopedic device (product code JDW) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K011137 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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 54
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K011137.
STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM
K012270 · Stryker Endoscopy · Sep 2001
MODIFICATION TO THE TAC' PIN
K011875 · New Deal, S.A. · Sep 2001
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
K011319 · Stryker Endoscopy · Jul 2001
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