Cleared Traditional

FIGURE 8 STERNOTOMY CLOSURE DEVICE (K110541) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K110541 · Figure 8 Surgical, Incorporated · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
131d
Days
Class 2
Risk

K110541 is an FDA 510(k) clearance for the FIGURE 8 STERNOTOMY CLOSURE DEVICE. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Figure 8 Surgical, Incorporated (Sunnyvale, US). The FDA issued a Cleared decision on July 6, 2011 after a review of 131 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 Figure 8 Surgical, Incorporated devices

Submission Details

510(k) Number K110541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2011
Decision Date July 06, 2011
Days to Decision 131 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
9d slower than avg
Panel avg: 122d · This submission: 131d
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 50
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K110541.
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K150889 · Zimmer, Inc. · Jul 2015
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K133354 · Biomet, Inc. · Jan 2014
SYNTHES STERNAL ZIPFIX SYSTEM
K110789 · Synthes (Usa) · Jul 2011
SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS
K081205 · Synthes (Usa) · Jul 2008
AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM
K063017 · Aesculap, Inc. · Dec 2006
SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM
K050041 · Synthes (Usa) · Feb 2005