Cleared Traditional

K112278 - ASCENSION NUGRIP CMC IMPLANT

K112278 is an FDA 510(k) clearance for ASCENSION NUGRIP CMC IMPLANT, manufactured by Ascension Orthopedic. The device is a Class 2 Orthopedic device with product code KYI cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K112278 · Ascension Orthopedic · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
87d
Days
Class 2
Risk

K112278 is an FDA 510(k) clearance for the ASCENSION NUGRIP CMC IMPLANT. Classified as Prosthesis, Wrist, Carpal Trapezium (product code KYI), Class II - Special Controls.

Submitted by Ascension Orthopedic (Austin, US). The FDA issued a Cleared decision on November 4, 2011 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3770 - 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.

FDA 510(k) Submission Details - K112278

510(k) Number K112278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2011
Decision Date November 04, 2011
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KYI Device Classification - Class 2, Special Controls

Product Code KYI Prosthesis, Wrist, Carpal Trapezium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3770
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 - KYI Prosthesis, Wrist, Carpal Trapezium

All 23
Devices cleared under the same product code (KYI) and FDA review panel - the closest regulatory comparables to K112278.
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