Cleared Traditional

K111122 - AESCULAP SIBD XP SPINAL SYSTEM

K111122 is an FDA 510(k) clearance for AESCULAP SIBD XP SPINAL SYSTEM, manufactured by Aesculap Implant Systems, Inc.. The device is a Class 2 Orthopedic device with product code OVD cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K111122 · Aesculap Implant Systems, Inc. · Orthopedic device
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Aug 2011
Decision
105d
Days
Class 2
Risk

K111122 is an FDA 510(k) clearance for the AESCULAP SIBD XP SPINAL SYSTEM. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Aesculap Implant Systems, Inc. (Center Valley, US). The FDA issued a Cleared decision on August 4, 2011 after a review of 105 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 - K111122

510(k) Number K111122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2011
Decision Date August 04, 2011
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OVD Device Classification - Class 2, Special Controls

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 160
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K111122.
NUVASIVE COROENT NO-PROFILE SYSTEM
K112561 · Nuvasive, Inc. · Mar 2012
SOVEREIGN SPINAL SYSTEM
K110063 · Medtronic Sofamor Danek, Inc. · Oct 2011
LDR SPINE ROI-A INTERBODY FUSION SYSTEM
K110327 · Ldr Spine USA · Sep 2011
INTERCONTINENTAL PLATE-SPACER
K103382 · Globus Medical, Inc. · May 2011
VAULT ALIF SYSTEM
K103369 · Spinal USA · Apr 2011
SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM
K102402 · Alphatec Spine, Inc. · Mar 2011