Cleared Traditional

K171938 - KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set

K171938 is an FDA 510(k) clearance for KYPHON Xpede Bone Cement, manufactured by Medtronic. The device is a Class 2 Orthopedic device with product code PML cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K171938 · Medtronic · Orthopedic device
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Oct 2017
Decision
117d
Days
Class 2
Risk

K171938 is an FDA 510(k) clearance for the KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set. Classified as Bone Cement, Posterior Screw Augmentation (product code PML), Class II - Special Controls.

Submitted by Medtronic (Memphis, US). The FDA issued a Cleared decision on October 23, 2017 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 888.3027 - 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 Medtronic devices

FDA 510(k) Submission Details - K171938

510(k) Number K171938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2017
Decision Date October 23, 2017
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.

PML Device Classification - Class 2, Special Controls

Product Code PML Bone Cement, Posterior Screw Augmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
Definition The Device Is Intended To Augment The Fixation Of Screws In A Posterior Spinal System Construct.
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 - PML Bone Cement, Posterior Screw Augmentation

All 18
Devices cleared under the same product code (PML) and FDA review panel - the closest regulatory comparables to K171938.
Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set
K191148 · Medtronic Sofamor Danek USA, Inc. · Sep 2019
NuVasive Reline Fenestrated Screws, High V+ Bone Cement
K180498 · Nu Vasive, Incorporated · Nov 2018
FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System
K172269 · Globus Medical, Inc. · Mar 2018
CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems
K160879 · Medos International S?rl · Dec 2016
KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set
K152604 · Medtronic Sofamor Danek USA, Incorporated · Jan 2016