Cleared Traditional

K110789 - SYNTHES STERNAL ZIPFIX SYSTEM

K110789 is an FDA 510(k) clearance for SYNTHES STERNAL ZIPFIX SYSTEM, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K110789 · Synthes (Usa) · Orthopedic device
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Jul 2011
Decision
128d
Days
Class 2
Risk

K110789 is an FDA 510(k) clearance for the SYNTHES STERNAL ZIPFIX SYSTEM. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on July 28, 2011 after a review of 128 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K110789

510(k) Number K110789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2011
Decision Date July 28, 2011
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDQ Device Classification - Class 2, Special Controls

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 108
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K110789.
JAZZ SYSTEM
K121541 · Implanet, S.A. · Sep 2012
SPINAL ELEMENTS CERCLAGE SYSTEM
K120177 · Spinal Elements, Inc. · Jul 2012
PASS LP SPINAL
K112736 · Medicrea International · Feb 2012
FIGURE 8 STERNOTOMY CLOSURE DEVICE
K110541 · Figure 8 Surgical, Incorporated · Jul 2011
K2M COCR WIRE
K103797 · K2m, Inc. · May 2011
BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM
K110039 · Biomet Sports Medicine · May 2011