Cleared Traditional

K060762 - AESCULAP PEEK VERTEBRAL BODY REPLACEMEN...

K060762 is the FDA 510(k) clearance for AESCULAP PEEK VERTEBRAL BODY REPLACEMEN... by Aesculap, Inc.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K060762 · Aesculap, Inc. · Orthopedic device
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Sep 2006
Decision
177d
Days
Class 2
Risk

K060762 is an FDA 510(k) clearance for the AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on September 14, 2006 after a review of 177 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 Aesculap, Inc. devices

Submission Details

510(k) Number K060762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2006
Decision Date September 14, 2006
Days to Decision 177 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
55d slower than avg
Panel avg: 122d · This submission: 177d
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 158
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K060762.
VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS
K062666 · Ortho Development Corp. · Jan 2007
BOX PEEK VBR SYSTEM
K062151 · Innovasis, Inc. · Dec 2006
SOLITAIRE ANTERIOR SPINAL SYSTEM
K062810 · Ebi, L.P. · Oct 2006
VERTE-STACK SPINAL SYSTEM
K062427 · Medtronic Sofamor Danek · Sep 2006
AVS PL PEEK SPACER SYSTEM
K062132 · Stryker Spine · Aug 2006
VERTE-STACK SPINAL SYSTEM
K062073 · Medtronic Sofamor Danek · Aug 2006