Cleared Traditional

K053508 - SYNFIX-LR

K053508 is an FDA 510(k) clearance for SYNFIX-LR, manufactured by Synthes Spine Co.Lp. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K053508 · Synthes Spine Co.Lp · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
59d
Days
Class 2
Risk

K053508 is an FDA 510(k) clearance for the SYNFIX-LR. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Synthes Spine Co.Lp (West Chester, US). The FDA issued a Cleared decision on February 13, 2006 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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.

View all Synthes Spine Co.Lp devices

FDA 510(k) Submission Details - K053508

510(k) Number K053508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2005
Decision Date February 13, 2006
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 197
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K053508.
STAXX XD SYSTEM
K052670 · Spine Wave, Inc. · Apr 2006
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K060719 · Medtronic Sofamor Danek · Apr 2006
CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM
K060350 · Blackstone Medical, Inc. · Feb 2006
SEASPINE VBR SYSTEM
K052170 · Seaspine, Inc. · Dec 2005
GRAFTCAGE TLX
K051781 · Osteotech, Inc. · Dec 2005
NUVASIVE COROENT EXTENSURE SYSTEM
K052210 · Nuvasive, Inc. · Dec 2005