Cleared Traditional

NEWDEAL ANKLE NAIL (K050882) - FDA 510(k) Clearance

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

K050882 · New Deal, S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
50d
Days
Class 2
Risk

K050882 is an FDA 510(k) clearance for the NEWDEAL ANKLE NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by New Deal, S.A. (Planisboro, US). The FDA issued a Cleared decision on May 27, 2005 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 New Deal, S.A. devices

Submission Details

510(k) Number K050882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2005
Decision Date May 27, 2005
Days to Decision 50 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 122d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 257
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K050882.
SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM
K051678 · Synthes (Usa) · Sep 2005
T2 ANKLE ARTHRODESIS NAIL
K051590 · Howmedica Osteonics Corp. · Jul 2005
T2 RECON NAIL SYSTEM
K051624 · Howmedica Osteonics Corp. · Jul 2005
GAMMA3 NAIL SYSTEM
K043431 · Howmedica Osteonics Corp. · Feb 2005
MODIFICATION TO T2 PROXIMAL HUMERAL NAIL
K043404 · Howmedica Osteonics Corp. · Dec 2004
MODULAR ARTHRODESIS NAIL
K042409 · Biomet, Inc. · Dec 2004