Cleared Traditional

K072118 - STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT

K072118 is the FDA 510(k) clearance for STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT by Stryker Corp.. It is a Class 2 Orthopedic device (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

Submission Details

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.

Device Classification

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 48
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K072118.
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