Cleared Special

K002435 - MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)

K002435 is an FDA 510(k) clearance for MODIFICATION TO AXYA MEDICAL, manufactured by Axya Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Special 510(k) pathway after a 15-day FDA review.

K002435 · Axya Medical, Inc. · General & Plastic Surgery device
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Aug 2000
Decision
15d
Days
Class 2
Risk

K002435 is an FDA 510(k) clearance for the MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK). Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Axya Medical, Inc. (Beverly, US). The FDA issued a Cleared decision on August 24, 2000 after a review of 15 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5010 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Axya Medical, Inc. devices

FDA 510(k) Submission Details - K002435

510(k) Number K002435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2000
Decision Date August 24, 2000
Days to Decision 15 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

GAW Device Classification - Class 2, Special Controls

Product Code GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5010
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAW Suture, Nonabsorbable, Synthetic, Polypropylene

All 43
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K002435.
AMS SLING FIXATION SYSTEM
K010990 · American Medical Systems, Inc. · Jun 2001
SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)
K002557 · Axya Medical, Inc. · Oct 2000
PERCLOSE VASCULAR SUTURE DELIVERY DEVICE
K001703 · Abbott Vascular, Inc. · Oct 2000
PRONOVA NONABSORBABLE SUTURE, USP
K001625 · Ethicon, Inc. · Jul 2000
POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP
K001185 · Cp Medical · Jun 2000
MODIFICATION TO BONE ANCHOR AND KIT (BAK)
K994313 · Axya Medical, Inc. · Jan 2000