Cleared Traditional

K061891 - SYNEX II

K061891 is an FDA 510(k) clearance for SYNEX II, 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 46-day FDA review.

K061891 · Synthes Spine Co.Lp · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
46d
Days
Class 2
Risk

K061891 is an FDA 510(k) clearance for the SYNEX II. 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 August 18, 2006 after a review of 46 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 - K061891

510(k) Number K061891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2006
Decision Date August 18, 2006
Days to Decision 46 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
76d faster than avg
Panel avg: 122d · This submission: 46d
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 K061891.
SOLITAIRE ANTERIOR SPINAL SYSTEM
K062810 · Ebi, L.P. · Oct 2006
AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
K060762 · Aesculap, Inc. · Sep 2006
VERTE-STACK SPINAL SYSTEM
K062427 · Medtronic Sofamor Danek · Sep 2006
AVS PL PEEK SPACER SYSTEM
K062132 · Stryker Spine · Aug 2006
SPINAL USA VBR SYSTEM
K061752 · Spinal USA · Aug 2006
VERTE-STACK SPINAL SYSTEM
K062073 · Medtronic Sofamor Danek · Aug 2006