Cleared Traditional

K151056 - Aesculap T-Space PEEK and XP Spinal System

K151056 is an FDA 510(k) clearance for Aesculap T-Space PEEK and XP Spinal System, manufactured by Aesculap Implant Systems, LLC. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K151056 · Aesculap Implant Systems, LLC · Orthopedic device
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Aug 2015
Decision
115d
Days
Class 2
Risk

K151056 is an FDA 510(k) clearance for the Aesculap T-Space PEEK and XP Spinal System. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Aesculap Implant Systems, LLC (Center Valley, US). The FDA issued a Cleared decision on August 13, 2015 after a review of 115 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, LLC devices

FDA 510(k) Submission Details - K151056

510(k) Number K151056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2015
Decision Date August 13, 2015
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAX Device Classification - Class 2, Special Controls

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize 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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 648
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K151056.
NuVasive CoRoent Lumbar System
K151472 · Nu Vasive, Incorporated · Sep 2015
Cascadia Interbody System
K150481 · K2m, Inc. · Aug 2015
LnK Lumbar Interbody Fusion Cage System
K151140 · L & K Biomed Co., Ltd. · Aug 2015
CAPSTONE Spinal System, CLYDESDALE Spinal System
K151128 · Medtronic Sofamor Danek USA, Inc. · Aug 2015
NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System
K151374 · Nu Vasive, Incorporated · Aug 2015
Rampart-T Interbody Fusion System
K151020 · Spineology, Inc. · Jul 2015