Cleared Traditional

K010108 - USS-LINE EXTENSION

K010108 is the FDA 510(k) clearance for USS-LINE EXTENSION by Synthes. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K010108 · Synthes · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2001
Decision
145d
Days
Class 2
Risk

K010108 is an FDA 510(k) clearance for the USS-LINE EXTENSION. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Synthes (Paoli, US). The FDA issued a Cleared decision on June 6, 2001 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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.

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Submission Details

510(k) Number K010108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2001
Decision Date June 06, 2001
Days to Decision 145 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
23d slower than avg
Panel avg: 122d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 160
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K010108.
PASS SPINAL SYSTEM
K013191 · Encore Orthopedics, Inc. · Oct 2001
PASS SPINAL SYSTEM
K012175 · Encore Orthopedics, Inc. · Jul 2001
ISOLA BAND CLAMP
K010972 · Depuyacromed · Jun 2001
TRI-FIX SPINAL FIXATION SYSTEM
K010903 · Endius, Inc. · Jun 2001
TRI-FIX SPINAL FIXATION SYSTEM
K010922 · Endius, Inc. · Jun 2001
SYNERGY 4.0 MM, 4.5 MM VLS SCREWS
K011437 · Interpore Cross Intl. · Jun 2001