Cleared Traditional

K092047 - ASCENSION METAL GREAT TOE SYSTEM

K092047 is the FDA 510(k) clearance for ASCENSION METAL GREAT TOE SYSTEM by Ascension Orthopedics, Inc.. It is a Class 2 Orthopedic device (product code KWD) cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K092047 · Ascension Orthopedics, Inc. · Orthopedic device
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Jan 2010
Decision
192d
Days
Class 2
Risk

K092047 is an FDA 510(k) clearance for the ASCENSION METAL GREAT TOE SYSTEM. Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Ascension Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on January 14, 2010 after a review of 192 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3730 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Ascension Orthopedics, Inc. devices

Submission Details

510(k) Number K092047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2009
Decision Date January 14, 2010
Days to Decision 192 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
70d slower than avg
Panel avg: 122d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWD Prosthesis, Toe, Hemi-, Phalangeal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3730
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 - KWD Prosthesis, Toe, Hemi-, Phalangeal

All 15
Devices cleared under the same product code (KWD) and FDA review panel - the closest regulatory comparables to K092047.
Cannulated Hemi Implant
K190543 · Vilex IN Tennessee, Inc. · May 2019
Life Spine Metatarsal Hemi Implant
K161279 · Life Spine, Inc. · Feb 2017
BIOPRO HEMI-EDGE TOE SYSTEM
K121973 · Biopro, Inc. · Oct 2012
ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS
K063058 · Arthrex, Inc. · Jan 2007
TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870
K041595 · Biopro, Inc. · Nov 2004
ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
K030319 · Wrightmedicaltechnologyinc · Nov 2003