Cleared Traditional

K171299 - Fixone Biocomposite Anchor

K171299 is an FDA 510(k) clearance for Fixone Biocomposite Anchor, manufactured by Aju Pharm Co., Ltd.. The device is a Class 2 Orthopedic device with product code MAI cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K171299 · Aju Pharm Co., Ltd. · Orthopedic device
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Aug 2017
Decision
113d
Days
Class 2
Risk

K171299 is an FDA 510(k) clearance for the Fixone Biocomposite Anchor. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Aju Pharm Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on August 24, 2017 after a review of 113 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 Aju Pharm Co., Ltd. devices

FDA 510(k) Submission Details - K171299

510(k) Number K171299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2017
Decision Date August 24, 2017
Days to Decision 113 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 122d · This submission: 113d
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 172
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K171299.
Arthrex PushLock
K173240 · Arthrex, Inc. · Jan 2018
HEALIX ADVANCE KNOTLESS Anchor
K171114 · Medos International SARL · Nov 2017
CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver
K171592 · Conmed Corporation · Aug 2017
HEALIX ADVANCE Anchor with PERMATAPE Suture
K170639 · Medos International SARL · May 2017
Arthrex SwiveLock Anchors
K171141 · Arthrex, Inc. · May 2017
CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver
K170501 · Conmed Corporation · Mar 2017