Cleared Traditional

SYNFIX-LR (K053508) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 45
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K053508.
AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
K060762 · Aesculap, Inc. · Sep 2006
RETAIN RADIOLUCENT SPACER
K061380 · Globus Medical, Inc. · Jun 2006
XPAND RADIOLUCENT CORPECTOMY SPACER
K060665 · Globus Medical, Inc. · May 2006
MODIFICATION TO: VERTE-STACK SPINAL SYSTEM
K052261 · Medtronic Sofamor Danek USA, Inc. · Oct 2005
XPAND CORPECTOMY SPACER
K050850 · Globus Medical, Inc. · May 2005
SUSTAIN RADIOLUCENT SPACER
K040284 · Globus Medical, Inc. · Mar 2004