Cleared Special

K131035 - Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM

K131035 is an FDA 510(k) clearance for Y-KNOT FLEX ALL-SUTURE ANCHOR, manufactured by Linvatec Corporation D/B/A Conmed Linvatec. The device is a Class 2 Orthopedic device with product code MBI cleared through the Special 510(k) pathway after a 81-day FDA review.

K131035 · Linvatec Corporation D/B/A Conmed Linvatec · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
81d
Days
Class 2
Risk

K131035 is an FDA 510(k) clearance for the Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Linvatec Corporation D/B/A Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on July 2, 2013 after a review of 81 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. 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. Low regulatory complexity profile. 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 - K131035

510(k) Number K131035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2013
Decision Date July 02, 2013
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
Pathway characteristics
Modification to existing cleared device.

MBI Device Classification - Class 2, Special Controls

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 606
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K131035.
TOGGLELOC XTENDER
K130033 · Biomet Manufacturing Corp · Aug 2013
RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM
K130814 · Depuy Mitek, A Johnson & Johnson Company · Aug 2013
MULTIFIX S KNOTLESS FIXATION DEVICE
K131182 · Arthocare Corporation · Jul 2013
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)
K131683 · Depuy Mitek, Inc., A Johnson and Johnson Company · Jun 2013
ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM
K130217 · OrthoPediatrics Corp. · Jun 2013
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM)
K130539 · Depuy Mitek, A Johnson & Johnson Company · May 2013
K131035 · Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM
Download PDF FDA Summary Linvatec Corporation …