Cleared Traditional

K143473 - Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles

K143473 is an FDA 510(k) clearance for Short SureLock All-Suture Anchor, manufactured by Cayenne Medical, Inc.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K143473 · Cayenne Medical, Inc. · Orthopedic device
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Mar 2015
Decision
110d
Days
Class 2
Risk

K143473 is an FDA 510(k) clearance for the Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with ne.... 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 Cayenne Medical, Inc. (Scottsdale, US). The FDA issued a Cleared decision on March 25, 2015 after a review of 110 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. 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 Cayenne Medical, Inc. devices

FDA 510(k) Submission Details - K143473

510(k) Number K143473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2014
Decision Date March 25, 2015
Days to Decision 110 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
12d faster than avg
Panel avg: 122d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 564
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K143473.
Stryker ICONIX with Needles
K151201 · Stryker · Jun 2015
Arthrex FiberTak Anchors
K151230 · Arthrex, Inc. · Jun 2015
JuggerStitch Meniscal Repair Device
K150424 · Biomet Manufacturing Corp · May 2015
Extremity Medical Suture Anchor
K150166 · Extremity Medical, LLC · Feb 2015
Quattro Bolt Tenodesis Screw
K143392 · Cayenne Medical, Inc. · Jan 2015
Stabilynx PEEK Suture Anchor
K142643 · D3 Dc, LLC /Stabilynx, Inc. · Dec 2014