Cleared Traditional

K111048 - SYNTHES SCOUT TACK FIXATION (FDA 510(k) Clearance)

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

K111048 · Synthes Spine · Orthopedic device
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Jun 2012
Decision
426d
Days
Class 2
Risk

K111048 is an FDA 510(k) clearance for the SYNTHES SCOUT TACK FIXATION. Classified as Vessel Guard Or Cover (product code OMR), Class II - Special Controls.

Submitted by Synthes Spine (West Chester, US). The FDA issued a Cleared decision on June 14, 2012 after a review of 426 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 870.3470 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Synthes Spine devices

Submission Details

510(k) Number K111048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received April 15, 2011
Decision Date June 14, 2012
Days to Decision 426 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
304d slower than avg
Panel avg: 122d · This submission: 426d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OMR Vessel Guard Or Cover
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3470
Definition These Device Types Do Not Include Devices Whose Primary Purpose Is To Minimize The Incidence Or Severity Of Adhesion Formation As A Result Of Vascular Surgery. Intended To Protect Vessels From Injury During Surgery (not To Be Confused With Wraps, Patches Or Covers Intended To Facilitate Revision Surgeries). Indicated To Wrap, Patch, Or Cover Intended To Cover Blood Vessels.
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.