Cleared Traditional

K092047 - ASCENSION METAL GREAT TOE SYSTEM

K092047 is an FDA 510(k) clearance for ASCENSION METAL GREAT TOE SYSTEM, manufactured by Ascension Orthopedics, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K092047

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
Combination Product No
PCCP Authorized No
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.

KWD Device Classification - Class 2, Special Controls

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 31
Devices cleared under the same product code (KWD) and FDA review panel - the closest regulatory comparables to K092047.
BIOPRO HEMI-EDGE TOE SYSTEM
K121973 · Biopro, Inc. · Oct 2012
METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET
K113752 · Solana Surgical, LLC · Feb 2012
HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET
K120029 · Solana Surgical, LLC · Feb 2012
OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING
K081876 · Osteomed LP · Aug 2008
SBI SR MTP TOE IMPLANT
K073635 · Small Bone Innovations, Inc. · Mar 2008
OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM
K073065 · Osteomed LP · Feb 2008