Cleared Traditional

K971358 - BIO-INTERFERENCE SCREW

K971358 is the FDA 510(k) clearance for BIO-INTERFERENCE SCREW by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code MAI) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K971358 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
89d
Days
Class 2
Risk

K971358 is an FDA 510(k) clearance for the BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Arthrex, Inc. (Washington, US). The FDA issued a Cleared decision on July 9, 1997 after a review of 89 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 Arthrex, Inc. devices

Submission Details

510(k) Number K971358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1997
Decision Date July 09, 1997
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 162
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K971358.
BIOROC EZ SUTURE BONE FASTENER
K973381 · Innovasive Devices, Inc. · Feb 1998
FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE
K965228 · United States Surgical, A Division of Tyco Healthc · Nov 1997
THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC*
K973281 · United States Surgical, A Division of Tyco Healthc · Nov 1997
BIO-ANCHOR
K964805 · Linvatec Corp. · Jun 1997
MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM
K970896 · Ethicon, Inc. · Jun 1997
BIO-ANCHOR
K963369 · Linvatec Corp. · May 1997