Cleared Traditional

K123651 - CINCHLOCK KNOTLESS SUTURE ANCHOR

K123651 is the FDA 510(k) clearance for CINCHLOCK KNOTLESS SUTURE ANCHOR by Pivot Medical. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K123651 · Pivot Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
86d
Days
Class 2
Risk

K123651 is an FDA 510(k) clearance for the CINCHLOCK 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 February 21, 2013 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pivot Medical devices

Submission Details

510(k) Number K123651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2012
Decision Date February 21, 2013
Days to Decision 86 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 122d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K123651.
KNOTLESS FIBERTAK SUTURE ANCHOR
K130458 · Arthrex, Inc. · May 2013
ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS
K122059 · Smith & Nephew, Inc. · Mar 2013
SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR
K130196 · Arthrocare Corp. · Feb 2013
TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL
K123425 · Smith & Nephew, Inc. · Feb 2013
SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT
K123240 · ArthroCare Corporation · Feb 2013
FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL
K123579 · Smith & Nephew, Inc. · Jan 2013