Cleared Special

K151314 - CinchLock Flex Knotless Suture Anchor

K151314 is the FDA 510(k) clearance for CinchLock Flex Knotless Suture Anchor by Pivot Medical. It is a Class 2 Orthopedic device (product code MBI) cleared through the Special 510(k) pathway after a 66-day FDA review.

K151314 · Pivot Medical · Orthopedic device
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Jul 2015
Decision
66d
Days
Class 2
Risk

K151314 is an FDA 510(k) clearance for the CinchLock Flex Knotless Suture Anchor. 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 Pivot Medical (Sunnyvale, US). The FDA issued a Cleared decision on July 23, 2015 after a review of 66 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.

View all Pivot Medical devices

Submission Details

510(k) Number K151314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2015
Decision Date July 23, 2015
Days to Decision 66 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 122d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 391
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K151314.
Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm
K150648 · Arthrex, Inc. · Aug 2015
MultiFIX® P Knotless Fixation Device
K151897 · ArthroCare Corporation · Aug 2015
2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors
K150715 · Tornier, Inc. · Jul 2015
MultiFIX S Knotless Fixation System
K151660 · ArthroCare Corporation · Jul 2015
GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle
K151037 · Conmed Corporation · Jul 2015
Arthrex Corkscrew and SwiveLock Suture Anchors
K143745 · Arthrex, Inc. · Jul 2015