Cleared Traditional

K112990 - ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE

K112990 is an FDA 510(k) clearance for ACL TIGHTROPE, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K112990 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Dec 2011
Decision
74d
Days
Class 2
Risk

K112990 is an FDA 510(k) clearance for the ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on December 19, 2011 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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

FDA 510(k) Submission Details - K112990

510(k) Number K112990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2011
Decision Date December 19, 2011
Days to Decision 74 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
48d faster than avg
Panel avg: 122d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HTY Pin, Fixation, Smooth

All 163
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K112990.
APEX KIRSCHNER WIRES AND STEINMANN PINS
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ARROW-LOK DIGITAL SYSTEM
K112675 · Arrowhead Medical Device Technologies, LLC · Dec 2011
MEMOMETAL INTRA-MEDULLARY BONE FASTENER
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APEX KIRSCHNER WIRES AND STEINMANN PINS
K112254 · Apex Tools & Orthopedics Co. · Oct 2011