Cleared Special

K110633 - LANCER PEDICLE SCREW SYSTEM

K110633 is an FDA 510(k) clearance for LANCER PEDICLE SCREW SYSTEM, manufactured by Spinal Solutions, LLC. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 286-day FDA review.

K110633 · Spinal Solutions, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
286d
Days
Class 2
Risk

K110633 is an FDA 510(k) clearance for the LANCER PEDICLE SCREW SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Spinal Solutions, LLC (Round Rock, US). The FDA issued a Cleared decision on December 15, 2011 after a review of 286 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K110633

510(k) Number K110633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2011
Decision Date December 15, 2011
Days to Decision 286 days
Submission Type Special
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
164d slower than avg
Panel avg: 122d · This submission: 286d
Pathway characteristics
Modification to existing cleared device.

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 308
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K110633.
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DEVINE SPINAL SYSTEM
K111690 · Changzhou Orthmed Medical Instrument Co., Ltd. · Nov 2011
PASS LP SPINAL SYSTEM
K110497 · Medicrea International · Sep 2011
K110633 · LANCER PEDICLE SCREW SYSTEM
Download PDF FDA Summary Spinal Solutions, LLC