Cleared Traditional

K961101 - STRYKER CEMENT REMOVAL SYSTEM (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961101 · Stryker Corp. · Orthopedic device
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Jul 1996
Decision
118d
Days
Class 2
Risk

K961101 is an FDA 510(k) clearance for the STRYKER CEMENT REMOVAL SYSTEM. Classified as System, Cement Removal Extraction (product code LZV), Class II - Special Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on July 15, 1996 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4580 - 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 K961101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1996
Decision Date July 15, 1996
Days to Decision 118 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
4d faster than avg
Panel avg: 122d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZV System, Cement Removal Extraction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.4580
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.