Cleared Traditional

K101126 - PONTIS SUTURES AND SUTURE ANCHORS WITH ...

K101126 is the FDA 510(k) clearance for PONTIS SUTURES AND SUTURE ANCHORS WITH ... by Core Essence Orthopaedics, Inc.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K101126 · Core Essence Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
224d
Days
Class 2
Risk

K101126 is an FDA 510(k) clearance for the PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS. 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 Core Essence Orthopaedics, Inc. (Ft Washington, US). The FDA issued a Cleared decision on December 2, 2010 after a review of 224 days - an extended review 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: 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 Core Essence Orthopaedics, Inc. devices

Submission Details

510(k) Number K101126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2010
Decision Date December 02, 2010
Days to Decision 224 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
102d slower than avg
Panel avg: 122d · This submission: 224d
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 K101126.
BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR
K110145 · Biomet, Inc. · Mar 2011
5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL
K110164 · Arthrocare Corp. · Feb 2011
ARTHREX TIBIAL GRAFTBOLT
K103060 · Arthrex, Inc. · Jan 2011
SPEEDFIX SUTURE SYSTEM
K101437 · Arthrocare Corp. · Oct 2010
ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM
K102262 · Arthrocare Corp. · Oct 2010
INTRAFIX TIBIAL SHEATH
K102443 · Depuy Mitek, A Johnson & Johnson Company · Oct 2010