Cleared Traditional

K060762 - AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM

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

K060762 · Aesculap, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K060762

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.

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 267
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K060762.
SOLITAIRE ANTERIOR SPINAL SYSTEM
K062810 · Ebi, L.P. · Oct 2006
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K062133 · Medtronic Spinal and Biologics Div · Sep 2006
VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM
K061155 · Zimmer Trabecular · Sep 2006
VERTE-STACK SPINAL SYSTEM
K062427 · Medtronic Sofamor Danek · Sep 2006
INTERPLATE VBR SYSTEM
K061401 · Rsb Spine, LLC · Aug 2006
SYNEX II
K061891 · Synthes Spine Co.Lp · Aug 2006