Cleared Traditional

K101837 - ACL TIGHTROPE DOUBLE BUNDLE

K101837 is the FDA 510(k) clearance for ACL TIGHTROPE DOUBLE BUNDLE by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HTY) cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K101837 · Arthrex, Inc. · Orthopedic device
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Dec 2010
Decision
180d
Days
Class 2
Risk

K101837 is an FDA 510(k) clearance for the ACL TIGHTROPE DOUBLE 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 28, 2010 after a review of 180 days - an extended review 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: 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 Arthrex, Inc. devices

Submission Details

510(k) Number K101837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2010
Decision Date December 28, 2010
Days to Decision 180 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
58d slower than avg
Panel avg: 122d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 96
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K101837.
RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM
K130105 · Depuy Mitek, A Johnson & Johnson Company · May 2013
ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE
K112990 · Arthrex, Inc. · Dec 2011
PCL TIGHTROPE
K110123 · Arthrex, Inc. · Apr 2011
ACL TIGHTROPE
K100652 · Arthrex, Inc. · Jun 2010
STRYKER SONICPIN SYSTEM
K091955 · Howmedica Osteonics Corp. · Apr 2010
APTUS K-WIRE SYSTEM
K092038 · Medartis AG · Sep 2009