Cleared Traditional

K072118 - STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT

K072118 is an FDA 510(k) clearance for STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT, manufactured by Stryker Corp.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K072118 · Stryker Corp. · Orthopedic device
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Dec 2007
Decision
128d
Days
Class 2
Risk

K072118 is an FDA 510(k) clearance for the STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on December 7, 2007 after a review of 128 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 Stryker Corp. devices

FDA 510(k) Submission Details - K072118

510(k) Number K072118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2007
Decision Date December 07, 2007
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDN Device Classification - Class 2, Special Controls

Product Code NDN Cement, Bone, Vertebroplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 - NDN Cement, Bone, Vertebroplasty

All 93
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K072118.
INFLATABLE BONE TAMP
K090211 · Cardinal Health, Inc. · Jul 2009
CORTOSS BONE AUGMENTATION MATERIAL
K080108 · Orthovita, Inc. · Jun 2009
MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)
K071375 · Disc-O-Tech Medical Technologies, Ltd. · Dec 2007
AVAFLEX VERTEBRAL AUGMENTATION NEEDLE
K072133 · Cardinal Health, Inc. · Nov 2007
ARCUATE VERTEBRAL AUGMENTATION SYSTEM
K070527 · Medtronic Sofamor Danek · May 2007
ARCUATE VERTEBRAL AUGMENTATION SYSTEM
K063248 · Medtronic Sofamor Danek · Mar 2007