Cleared Traditional

K010528 - TITANIUM CEMENT RESTRICTOR MATERIAL PEEK

K010528 is the FDA 510(k) clearance for TITANIUM CEMENT RESTRICTOR MATERIAL PEEK by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 Orthopedic device (product code JDK) cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K010528 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Oct 2001
Decision
229d
Days
Class 2
Risk

K010528 is an FDA 510(k) clearance for the TITANIUM CEMENT RESTRICTOR MATERIAL PEEK. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on October 10, 2001 after a review of 229 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - 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 Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K010528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received February 23, 2001
Decision Date October 10, 2001
Days to Decision 229 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
107d slower than avg
Panel avg: 122d · This submission: 229d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDK Prosthesis, Hip, Cement Restrictor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - JDK Prosthesis, Hip, Cement Restrictor

All 30
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K010528.
FORTITUDE CEMENT RESTRICTOR
K021719 · Spinal Concepts, Inc. · Aug 2002
CADENCE CEMENT RESTRICTOR
K022218 · Spinal Concepts, Inc. · Aug 2002
CEMENT RESTRICTOR
K013663 · Medtronic Sofamor Danek, Inc. · Dec 2001
BLOCK CEMENT RESTRICTOR (CR) - TITANIUM
K013014 · Medtronic Sofamor Danek, Inc. · Oct 2001
THREADED CEMENT RESTRICTOR (CR) TITANIUM
K011443 · Medtronic Sofamor Danek USA, Inc. · Aug 2001
MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K012255 · Medtronic Sofamor Danek, Inc. · Aug 2001