Cleared Traditional

K061451 - ASCENSION

K061451 is an FDA 510(k) clearance for ASCENSION, manufactured by Ascension Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code KYI cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K061451 · Ascension Orthopedics, Inc. · Orthopedic device
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Aug 2006
Decision
78d
Days
Class 2
Risk

K061451 is an FDA 510(k) clearance for the ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40. Classified as Prosthesis, Wrist, Carpal Trapezium (product code KYI), Class II - Special Controls.

Submitted by Ascension Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on August 11, 2006 after a review of 78 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.

View all Ascension Orthopedics, Inc. devices

FDA 510(k) Submission Details - K061451

510(k) Number K061451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2006
Decision Date August 11, 2006
Days to Decision 78 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
44d faster than avg
Panel avg: 122d · This submission: 78d
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 14
Devices cleared under the same product code (KYI) and FDA review panel - the closest regulatory comparables to K061451.
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
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K052596 · Biopro, Inc. · Nov 2005
ASCENSION PYROSPHERE (PCS)
K042690 · Ascension Orthopedics, Inc. · Nov 2004