Cleared Traditional

K062933 - SYNTHES ORACLE SPACER

K062933 is an FDA 510(k) clearance for SYNTHES ORACLE SPACER, 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 125-day FDA review.

K062933 · Synthes Spine Co.Lp · Orthopedic device
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Jan 2007
Decision
125d
Days
Class 2
Risk

K062933 is an FDA 510(k) clearance for the SYNTHES ORACLE SPACER. 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 January 31, 2007 after a review of 125 days - within the typical 510(k) review window.

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 Spine Co.Lp devices

FDA 510(k) Submission Details - K062933

510(k) Number K062933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2006
Decision Date January 31, 2007
Days to Decision 125 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
3d slower than avg
Panel avg: 122d · This submission: 125d
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 K062933.
VERTE-STACK SPINAL SYSTEM
K070173 · Medtronic Sofamor Danek, Inc. · Mar 2007
T2 SCEPTOR SPINAL SYSTEM
K063491 · Medtronic Sofamor Danek · Mar 2007
ALEUTIAN SPACER SYSTEM
K063399 · K2m, Inc. · Feb 2007
VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS
K062666 · Ortho Development Corp. · Jan 2007
OBELISC VERTEBRAL BODY REPLACEMENT DEVICE
K060416 · Ulrich GmbH & Co. KG · Dec 2006
BOX PEEK VBR SYSTEM
K062151 · Innovasis, Inc. · Dec 2006