Cleared Traditional

K011037 - VERTEBRAL SPACER

K011037 is the FDA 510(k) clearance for VERTEBRAL SPACER by Synthes (Usa). It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 452-day FDA review.

K011037 · Synthes (Usa) · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2002
Decision
452d
Days
Class 2
Risk

K011037 is an FDA 510(k) clearance for the VERTEBRAL SPACER. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on July 1, 2002 after a review of 452 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Synthes (Usa) devices

Submission Details

510(k) Number K011037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2001
Decision Date July 01, 2002
Days to Decision 452 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
330d slower than avg
Panel avg: 122d · This submission: 452d
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 156
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K011037.
HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
K022563 · Implex Corp. · Aug 2002
VERTE-STACK SPINAL SYSTEM
K021791 · Medtronic Sofamor Danek · Aug 2002
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2
K021967 · Implex Corp. · Jul 2002
MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K021025 · Implex Corp. · May 2002
EBI AIS SPINE SYSTEM
K020887 · Ebi, L.P. · May 2002
SYNTHES VERTEBRAL SPACER TI
K020152 · Synthes (Usa) · Apr 2002