Cleared Traditional

K111799 - NUGAIT(TM) SUBTALAR IMPLANT SYSTEM

K111799 is an FDA 510(k) clearance for NUGAIT(TM) SUBTALAR IMPLANT SYSTEM, manufactured by Ascension Orthopedic. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K111799 · Ascension Orthopedic · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
53d
Days
Class 2
Risk

K111799 is an FDA 510(k) clearance for the NUGAIT(TM) SUBTALAR IMPLANT SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Ascension Orthopedic (Austin, US). The FDA issued a Cleared decision on August 19, 2011 after a review of 53 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 Ascension Orthopedic devices

FDA 510(k) Submission Details - K111799

510(k) Number K111799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2011
Decision Date August 19, 2011
Days to Decision 53 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
69d faster than avg
Panel avg: 122d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 742
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K111799.
ZIMMER PERIARTICULAR SCREWS
K111447 · Zimmer, Inc. · Oct 2011
MICROSUTURE ANCHORS
K112237 · Arthrex, Inc. · Sep 2011
SLIC SCREW REPAIR SYSTEM
K111608 · Acumed, LLC · Aug 2011
PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR
K111000 · Parcus Medical, LLC · Jul 2011
3.7MM/5.0MM DYNAMIC LOCKING SCREW
K110592 · Synthes (Usa) · Jul 2011
AAP CANNULATED SCREWS
K111316 · Aap Implantate AG · Jul 2011