Cleared Traditional

K081331 - FIXXSURE CROSS LINK

K081331 is an FDA 510(k) clearance for FIXXSURE CROSS LINK, manufactured by Spineworks, LLC. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K081331 · Spineworks, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
72d
Days
Class 2
Risk

K081331 is an FDA 510(k) clearance for the FIXXSURE CROSS LINK. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Spineworks, LLC (Round Rock, US). The FDA issued a Cleared decision on July 23, 2008 after a review of 72 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K081331

510(k) Number K081331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2008
Decision Date July 23, 2008
Days to Decision 72 days
Submission Type Traditional
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
50d faster than avg
Panel avg: 122d · This submission: 72d
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 308
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K081331.
PASS LP SPINAL SYSTEM
K082577 · Medicrea Technologies · Oct 2008
MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM
K081883 · Us Spine · Sep 2008
4CIS SOLAR AND APOLLON SPINE SYSTEMS
K082453 · Solco Biomedical Co., Ltd. · Sep 2008
SINTEA BIOTECH PLS MULTI-AXIAL SCREWS
K081631 · Sintea Biotech, Inc. · Jul 2008
MOUNTAINEER OCT SPINAL SYSTEM
K080828 · Depuy Spine, Inc. · Jun 2008
GPS, G SURGICAL PEDICLE SYSTEM
K081041 · G Surgical Co., Ltd. · Jun 2008
K081331 · FIXXSURE CROSS LINK
Download PDF FDA Summary Spineworks, LLC