Cleared Traditional

K012462 - THEKEN LARGE CEMENT RESTRICTOR

K012462 is an FDA 510(k) clearance for THEKEN LARGE CEMENT RESTRICTOR, manufactured by Theken Surgical,Llc. The device is a Class 2 Orthopedic device with product code JDK cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K012462 · Theken Surgical,Llc · Orthopedic device
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Oct 2001
Decision
89d
Days
Class 2
Risk

K012462 is an FDA 510(k) clearance for the THEKEN LARGE CEMENT RESTRICTOR. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Theken Surgical,Llc (Barberton, US). The FDA issued a Cleared decision on October 29, 2001 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Theken Surgical,Llc devices

FDA 510(k) Submission Details - K012462

510(k) Number K012462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received August 01, 2001
Decision Date October 29, 2001
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDK Device Classification - Class 2, Special Controls

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 38
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K012462.
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
TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
K010528 · Medtronic Sofamor Danek USA, Inc. · Oct 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