Cleared Traditional

K123909 - AESCULAP CESPACE XP

K123909 is an FDA 510(k) clearance for AESCULAP CESPACE XP, manufactured by Aesculap Implant System, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K123909 · Aesculap Implant System, Inc. · Orthopedic device
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Apr 2013
Decision
117d
Days
Class 2
Risk

K123909 is an FDA 510(k) clearance for the AESCULAP CESPACE XP. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Aesculap Implant System, Inc. (Center Valley, US). The FDA issued a Cleared decision on April 15, 2013 after a review of 117 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 System, Inc. devices

FDA 510(k) Submission Details - K123909

510(k) Number K123909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2012
Decision Date April 15, 2013
Days to Decision 117 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
5d faster than avg
Panel avg: 122d · This submission: 117d
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 Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 336
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K123909.
TRANSCORP ACIF SYSTEM
K121178 · Transcorp, Inc. · Jul 2013
VUSION CS PLUS
K122588 · Ortho Development Corp. · Jun 2013
PROVIDENCE CERVICAL CAGE
K122801 · Providence Medical Technology, Inc. · May 2013
TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES
K122850 · Meditech Advisors, LLC · Mar 2013
INTERVERTEBRAL BODY FUSION DEVICE
K122872 · Dio Medical Co., Ltd. · Feb 2013
SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE
K122518 · Bm Korea Co., Ltd. · Feb 2013