Cleared Traditional

K992405 - AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK)

K992405 is an FDA 510(k) clearance for AXYA MEDICAL INC, manufactured by Axya Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K992405 · Axya Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
64d
Days
Class 2
Risk

K992405 is an FDA 510(k) clearance for the 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 September 22, 1999 after a review of 64 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. 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.

FDA 510(k) Submission Details - K992405

510(k) Number K992405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1999
Decision Date September 22, 1999
Days to Decision 64 days
Submission Type Traditional
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
51d faster than avg
Panel avg: 115d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 84
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K992405.
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP
K000537 · Arc Medical Supplies (Beijing) Co, Ltd. · Apr 2000
POLYPROPYLENE
K993997 · Trading Consultants and Distributors Intl., Inc. · Feb 2000
MODIFICATION TO BONE ANCHOR AND KIT (BAK)
K994313 · Axya Medical, Inc. · Jan 2000
SUTURE WELDING SYSTEM AND KIT (SWK)
K983108 · Axya Medical, Inc. · Nov 1998
PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
K980703 · Aesculap, Inc. · May 1998
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
K961389 · R. K. Medical L. L. C. · Jun 1996
K992405 · AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK)
Download PDF FDA Summary Axya Medical, Inc.