Cleared Special

K103085 - VENUS BASIC SPINAL FIXATION SYSTEM

K103085 is an FDA 510(k) clearance for VENUS BASIC SPINAL FIXATION SYSTEM, manufactured by L & K Biomed Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 113-day FDA review.

K103085 · L & K Biomed Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
113d
Days
Class 2
Risk

K103085 is an FDA 510(k) clearance for the VENUS BASIC SPINAL FIXATION SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by L & K Biomed Co., Ltd. (Geumcheon-Gu, Seoul, KR). The FDA issued a Cleared decision on February 9, 2011 after a review of 113 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. 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.

View all L & K Biomed Co., Ltd. devices

FDA 510(k) Submission Details - K103085

510(k) Number K103085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2010
Decision Date February 09, 2011
Days to Decision 113 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
9d faster than avg
Panel avg: 122d · This submission: 113d
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 278
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K103085.
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
K102458 · Solco Biomedical Co., Ltd. · Jun 2011
TIGER SPINE SYSTEM
K110321 · Corelink, LLC · May 2011
4CIS VANE SPINE SYSTEM
K101818 · Solco Biomedical Co., Ltd. · Feb 2011
FLAMENCO SPINAL FIXATION SYSTEM
K102853 · Ulrich GmbH & Co. KG · Jan 2011
EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM
K102870 · Exactech, Inc. · Jan 2011
INERTIA PEDICLE SCREW SYSTEM
K101278 · Nexxt Spine, LLC · Dec 2010