Cleared Traditional

K924657 - TRUE/FLEX METATARSAL RODS

K924657 is an FDA 510(k) clearance for TRUE/FLEX METATARSAL RODS, manufactured by Applied Osteo Systems, Inc.. The device is a Class 2 Orthopedic device with product code KTW cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K924657 · Applied Osteo Systems, Inc. · Orthopedic device
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Nov 1992
Decision
70d
Days
Class 2
Risk

K924657 is an FDA 510(k) clearance for the TRUE/FLEX METATARSAL RODS. Classified as Appliance, Fixation, Nail/blade/plate Combination, Single Component (product code KTW), Class II - Special Controls.

Submitted by Applied Osteo Systems, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on November 24, 1992 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Applied Osteo Systems, Inc. devices

FDA 510(k) Submission Details - K924657

510(k) Number K924657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1992
Decision Date November 24, 1992
Days to Decision 70 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTW Device Classification - Class 2, Special Controls

Product Code KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component

All 32
Devices cleared under the same product code (KTW) and FDA review panel - the closest regulatory comparables to K924657.
SYNTHES CANNULATED ANGLE BLADE PLATE
K954289 · Synthes (Usa) · Nov 1995
MALLEOLAR SCREW
K931686 · Onyx Medical Corp. · Apr 1994
TORUS EXTERNAL FIXATION SYSTEM
K925635 · Zimmer, Inc. · Jun 1993
ANGLED BLADE PLATE
K914546 · Synthes (Usa) · Nov 1991
HANSEN-STREET TYPE INTRAMEDULLARY NAIL
K905348 · O'Tec Corp. · Dec 1990
LEVTECH SMALL BONE PLATE
K893928 · Buckman Co., Inc. · Nov 1989