Cleared Traditional

K110039 - BIOMET SPORTS MEDICINE STERNAL CLOSURE ...

K110039 is the FDA 510(k) clearance for BIOMET SPORTS MEDICINE STERNAL CLOSURE ... by Biomet Sports Medicine. It is a Class 2 Orthopedic device (product code JDQ) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K110039 · Biomet Sports Medicine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
117d
Days
Class 2
Risk

K110039 is an FDA 510(k) clearance for the BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Biomet Sports Medicine (Warsaw, US). The FDA issued a Cleared decision on May 3, 2011 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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 Biomet Sports Medicine devices

Submission Details

510(k) Number K110039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2011
Decision Date May 03, 2011
Days to Decision 117 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
5d faster than avg
Panel avg: 122d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 - JDQ Cerclage, Fixation

All 83
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K110039.
SPINAL ELEMENTS CERCLAGE SYSTEM
K120177 · Spinal Elements, Inc. · Jul 2012
SYNTHES STERNAL ZIPFIX SYSTEM
K110789 · Synthes (Usa) · Jul 2011
K2M COCR WIRE
K103797 · K2m, Inc. · May 2011
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063
K091190 · Zimmer Spine, Inc. · Jul 2009
SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS
K081205 · Synthes (Usa) · Jul 2008
AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM
K063017 · Aesculap, Inc. · Dec 2006