Cleared Traditional

K032687 - ACE NANCY NAIL

K032687 is an FDA 510(k) clearance for ACE NANCY NAIL, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K032687 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
38d
Days
Class 2
Risk

K032687 is an FDA 510(k) clearance for the ACE NANCY NAIL. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 6, 2003 after a review of 38 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 DePuy Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K032687

510(k) Number K032687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2003
Decision Date October 06, 2003
Days to Decision 38 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
84d faster than avg
Panel avg: 122d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
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 - HTY Pin, Fixation, Smooth

All 107
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K032687.
PINN-ACL CROSSPIN
K043106 · Linvatec Corp. · Jan 2005
HUMERAL STAPLE
K041355 · Smith & Nephew, Inc. · Jul 2004
HANSSON PIN SYSTEM
K033968 · Howmedica Osteonics Corp. · Feb 2004
INION OTPS BIODEGRADABLE PIN
K031712 · Inion , Ltd. · Aug 2003
K-FIX
K022597 · New Deal, S.A. · Nov 2002
NEWDEAL K WIRE
K022599 · New Deal, S.A. · Oct 2002