Cleared Traditional

K083311 - AESCULAP CESPACE PEEK INTERVERTEBRAL BO...

K083311 is an FDA 510(k) clearance for AESCULAP CESPACE PEEK INTERVERTEBRAL BO..., manufactured by Aesculap Implant Systems, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K083311 · Aesculap Implant Systems, Inc. · Orthopedic device
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Mar 2009
Decision
114d
Days
Class 2
Risk

K083311 is an FDA 510(k) clearance for the AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Aesculap Implant Systems, Inc. (Center Valley, US). The FDA issued a Cleared decision on March 4, 2009 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 Implant Systems, Inc. devices

FDA 510(k) Submission Details - K083311

510(k) Number K083311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2008
Decision Date March 04, 2009
Days to Decision 114 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
8d faster than avg
Panel avg: 122d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 Consultant

Aesculap AG
Kathy Racosky

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 245
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K083311.
SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE
K083118 · Spinal USA · May 2009
CALIX SPINAL IMPLANT SYSTEM
K083637 · X-Spine Systems, Inc. · Apr 2009
CAMBRIA
K082309 · Seaspine, Inc. · Apr 2009
NUVASIVE COROENT SYSTEM
K081611 · Nuvasive, Inc. · Oct 2008
NOVEL CERVICAL SPINAL SPACER SYSTEM
K081730 · Alphatec Spine, Inc. · Sep 2008
CRYSTAL
K073351 · Spinal Elements, Inc. · Jan 2008