Cleared Special

K100652 - ACL TIGHTROPE

K100652 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 Special 510(k) pathway after a 107-day FDA review.

K100652 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
107d
Days
Class 2
Risk

K100652 is an FDA 510(k) clearance for the ACL TIGHTROPE. 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 June 23, 2010 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K100652

510(k) Number K100652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2010
Decision Date June 23, 2010
Days to Decision 107 days
Submission Type Special
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
15d faster than avg
Panel avg: 122d · This submission: 107d
Pathway characteristics
Modification to existing cleared device.

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 205
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K100652.
ARROWHEAD FIXATION DEVICE
K100926 · Arrow Products, Inc. · Oct 2010
KIRSCHNER AND GUIDE WIRES
K100736 · Smt Schilling Metalltechnik GmbH · Sep 2010
LIGAMENTOTAXOR
K094043 · Arex USA · Aug 2010
STRYKER SONICPIN SYSTEM
K091955 · Howmedica Osteonics Corp. · Apr 2010
HAMMERLOCK
K091951 · Biomedical Ent., Inc. · Feb 2010
APTUS K-WIRE SYSTEM
K092038 · Medartis AG · Sep 2009
K100652 · ACL TIGHTROPE
Download PDF FDA Summary Arthrex, Inc.