Cleared Traditional

SMALL STATURE SPACERS (K063393) - FDA 510(k) Clearance

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

K063393 · Biomet Spine · Orthopedic device
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Jun 2007
Decision
228d
Days
Class 2
Risk

K063393 is an FDA 510(k) clearance for the SMALL STATURE SPACERS. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Biomet Spine (Warsaw, US). The FDA issued a Cleared decision on June 25, 2007 after a review of 228 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 Biomet Spine devices

Submission Details

510(k) Number K063393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2006
Decision Date June 25, 2007
Days to Decision 228 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
106d slower than avg
Panel avg: 122d · This submission: 228d
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 35
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K063393.
FORTIFY Corpectomy Spacers
K162315 · Globus Medical, Inc. · Nov 2017
NuVasive(r) Monolith Corpectomy System
K170271 · Nu Vasive, Incorporated · Mar 2017
FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)
K121107 · Globus Medical, Inc. · Jul 2012
AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
K060762 · Aesculap, Inc. · Sep 2006
STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM
K033837 · Howmedica Osteonics Corp. · Jan 2004
SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)
K024364 · Synthes (Usa) · Mar 2003