Cleared Traditional

K172032 - Modulift Vertebral Body Replacement (VB...

K172032 is an FDA 510(k) clearance for Modulift Vertebral Body Replacement (VB..., manufactured by Aesculap Implants Systems, Inc.. The device is a Class 2 Orthopedic device with product code PLR cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K172032 · Aesculap Implants Systems, Inc. · Orthopedic device
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Nov 2017
Decision
138d
Days
Class 2
Risk

K172032 is an FDA 510(k) clearance for the Modulift Vertebral Body Replacement (VBR) System. Classified as Spinal Vertebral Body Replacement Device - Cervical (product code PLR), Class II - Special Controls.

Submitted by Aesculap Implants Systems, Inc. (Center Valley, US). The FDA issued a Cleared decision on November 20, 2017 after a review of 138 days - within the typical 510(k) review window.

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 Implants Systems, Inc. devices

FDA 510(k) Submission Details - K172032

510(k) Number K172032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2017
Decision Date November 20, 2017
Days to Decision 138 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 122d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PLR Device Classification - Class 2, Special Controls

Product Code PLR Spinal Vertebral Body Replacement Device - Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
Definition Vertebral Body Replacement In The Cervical Spine.
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 - PLR Spinal Vertebral Body Replacement Device - Cervical

All 16
Devices cleared under the same product code (PLR) and FDA review panel - the closest regulatory comparables to K172032.
NuVasive Monolith Cervical Corpectomy System
K180550 · Nu Vasive, Incorporated · Nov 2018
Trabis
K173893 · Coligne AG · Sep 2018
Normandy VBR System
K180673 · Zavation Medical Products, LLC · Jul 2018
NuVasive X-CORE Mini Cervical Expandable VBR System
K151651 · Nu Vasive, Incorporated · Sep 2015