Cleared Traditional

K003836 - SYNTHES SYNEX SPACER SYSTEM

K003836 is the FDA 510(k) clearance for SYNTHES SYNEX SPACER SYSTEM by Synthes. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K003836 · Synthes · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
168d
Days
Class 2
Risk

K003836 is an FDA 510(k) clearance for the SYNTHES SYNEX SPACER SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Synthes (Paoli, US). The FDA issued a Cleared decision on May 29, 2001 after a review of 168 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Synthes devices

Submission Details

510(k) Number K003836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2000
Decision Date May 29, 2001
Days to Decision 168 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
46d slower than avg
Panel avg: 122d · This submission: 168d
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 159
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K003836.
LIFT VB SPINAL SYSTEM
K010930 · Medtronic Sofamor Danek, Inc. · Oct 2001
GEO STRUCTURE
K010530 · Interpore Cross Intl. · Aug 2001
SURGICAL DYNAMICS MESH CAGE SYSTEM
K003709 · United States Surgical, A Division of Tyco Healthc · Jul 2001
SURGICAL TITANIUM MESH SYSTEM
K003043 · Depuyacromed · May 2001
SYNTHES SYNMESH SPACER SYSTEM
K003275 · Synthes (Usa) · Apr 2001
STACKABLE CAGE SYSTEM
K001340 · Depuyacromed · Jul 2000