Cleared Traditional

K110348 - UNIVERSAL CLAMP SPINAL FIXATION SYSTEM

K110348 is an FDA 510(k) clearance for UNIVERSAL CLAMP SPINAL FIXATION SYSTEM, manufactured by Zimmer Spine. The device is a Class 2 Orthopedic device with product code OWI cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K110348 · Zimmer Spine · Orthopedic device
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Aug 2011
Decision
185d
Days
Class 2
Risk

K110348 is an FDA 510(k) clearance for the UNIVERSAL CLAMP SPINAL FIXATION SYSTEM. Classified as Bone Fixation Cerclage, Sublaminar (product code OWI), Class II - Special Controls.

Submitted by Zimmer Spine (Minneapolis, US). The FDA issued a Cleared decision on August 11, 2011 after a review of 185 days - an extended review cycle.

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 Zimmer Spine devices

FDA 510(k) Submission Details - K110348

510(k) Number K110348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2011
Decision Date August 11, 2011
Days to Decision 185 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
63d slower than avg
Panel avg: 122d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWI Device Classification - Class 2, Special Controls

Product Code OWI Bone Fixation Cerclage, Sublaminar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
Definition Acts As A Bone Anchor For Temporary Stabilization, Or Used In Conjunction With Other Medical Implants Of Similar Metals When Wiring Is Needed, During Development Of A Spinal Fusion.
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.