Cleared Traditional

K041698 - AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR

K041698 is an FDA 510(k) clearance for AXYA MEDICAL, manufactured by Axya Medical, Inc.. The device is a Class 2 Orthopedic device with product code MAI cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K041698 · Axya Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
105d
Days
Class 2
Risk

K041698 is an FDA 510(k) clearance for the AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Axya Medical, Inc. (Beverly, US). The FDA issued a Cleared decision on October 5, 2004 after a review of 105 days - within the typical 510(k) review window.

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: 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 Axya Medical, Inc. devices

FDA 510(k) Submission Details - K041698

510(k) Number K041698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2004
Decision Date October 05, 2004
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAI Device Classification - Class 2, Special Controls

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 209
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K041698.
PUSHLOCK
K051219 · Arthrex, Inc. · Jun 2005
AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
K051250 · Axya Medical, Inc. · Jun 2005
DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H
K042966 · Linvatec Biomaterials, Ltd. · Nov 2004
SUTURE ARROW
K041128 · Linvatec Corp. · Jul 2004
STRYKER BIOZIP SUTURE ANCHOR SYSTEM
K041305 · Stryker Endoscopy · Jun 2004
MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM
K041307 · Stryker Endoscopy · Jun 2004