Cleared Traditional

K083077 - ULC SPINAL PEDICLE SCREW SYSTEM

K083077 is an FDA 510(k) clearance for ULC SPINAL PEDICLE SCREW SYSTEM, manufactured by Otis Biotech Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 375-day FDA review.

K083077 · Otis Biotech Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
375d
Days
Class 2
Risk

K083077 is an FDA 510(k) clearance for the ULC SPINAL PEDICLE SCREW SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Otis Biotech Co., Ltd. (Siheung-Si, Gyounggi-Do, KR). The FDA issued a Cleared decision on October 26, 2009 after a review of 375 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Otis Biotech Co., Ltd. devices

FDA 510(k) Submission Details - K083077

510(k) Number K083077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2008
Decision Date October 26, 2009
Days to Decision 375 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
253d slower than avg
Panel avg: 122d · This submission: 375d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 180
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K083077.
MIS SYSTEM
K100605 · Spine Wave, Inc. · Jun 2010
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K093670 · Stryker Spine · Mar 2010
MODIFICATION TO CAPSURE PS SYSTEM
K100122 · Spine Wave, Inc. · Feb 2010
FORTEX PEDICLE SCREW SYSTEM
K090224 · X-Spine Systems, Inc. · Jul 2009
ROC LUMBAR PLATING SYSTEM
K090228 · Alphatec Spine, Inc. · Apr 2009
LANX SPINAL FIXATION SYSTEM
K083581 · Lanx, Inc. · Apr 2009