The Theken Large Cement Restrictor is designed to occlude the medullary canal before the introduction of acrylic cement during surgeries such as total hip arthroplasty, as well as prevent cement from flowing down the diaphysis thereby facilitating cement pressurization. The Theken Large Cement Restrictor is NOT intended for any spinal indications.

Device Description

The Theken Large Cement Restrictor is titanium, hollow, rectangular frame with The Thelions and radii on all sides and toothed spikes on opposite sides. The device is intended to be used in conjunction with standard PMMA cement.

AI/ML Overview

The provided text is a 510(k) summary for the Theken Large Cement Restrictor, an orthopedic surgical device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to previously marketed predicate devices (Signus Medizintechnik GmbH Rabea™ Cement Restrictor Device and Medtronic Sofamor Danek Titanium Cement Restrictor Device) for regulatory approval.

Here's a breakdown of why the requested information is absent based on the provided text:

Acceptance Criteria and Reported Device Performance:
- The document states "Static evaluation was performed and the strength of the device was characterized." However, it does not provide specific quantitative acceptance criteria for strength, nor does it present the numerical results ("reported device performance") from this characterization.
Sample Size for Test Set and Data Provenance:
- No information about a "test set" in the context of device performance testing is provided. The static evaluation mentioned is a non-clinical test, not a clinical study on a patient sample.
Number of Experts and Qualifications:
- This information is relevant for studies involving human interpretation (e.g., image-based diagnostics) or clinical ground truth establishment. This device's evaluation did not involve such expert review.
Adjudication Method:
- Not applicable as there's no expert-based ground truth establishment mentioned.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is an orthopedic implant, not an AI-assisted diagnostic tool.
Standalone Performance:
- The "Static evaluation" is a standalone test of the device's physical properties. However, as noted in point 1, the specific performance metrics and acceptance criteria are not detailed.
Type of Ground Truth Used:
- For the static evaluation, the "ground truth" would be the engineering specifications and test standards for material strength and mechanical properties. These are not explicitly detailed in the summary.
Sample Size for Training Set:
- Not applicable. This is not an AI/ML device that requires a training set.
How Ground Truth for Training Set was Established:
- Not applicable.

In summary, the provided 510(k) document is a regulatory submission for a physical medical device, not an AI/ML-based diagnostic or prognostic tool. Therefore, much of the requested information, which pertains to clinical studies, human expert involvement, and AI model evaluation, is not present in this type of document. The only performance data mentioned is a non-clinical "static evaluation," but the specifics of that evaluation (criteria and results) are not elaborated.

Summary

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510(k) Summary

012462

OCT 2 9 2001

Theken Large Cement Restrictor

510 (k) Summary

Theken Surgical Company: 1100 Nola Ave. Barberton, OH 44203
Theken Large Cement Restrictor Trade Name:

Classification: JDK 21CFR878.3300. Surgical Mesh. Class II.

Description:

Performance Data:

Non-clinical:

Static evaluation was performed and the strength of the device was characterized.

Intended Use:

Substantial Equivalence:

Signus Medizintechnik GmbH Rabea™ Cement Restrictor Device (K990345) Medtronic Sofamor Danek Titanium Cement Restrictor Device (K003718)

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes forming its wing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2001

Mr. Randy Theken Director Theken Surgical, LLC 1100 Nola Avenue Barberton, Ohio 44203

Re: K012462

Trade/Device Name: Theken Large Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: July 31, 2001 Received: August 1, 2001

Dear Mr. Theken:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's package insert and also as a Warning on the product label:

WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS.

THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

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Page 2 - Mr. Randy Theken

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address: http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bernard E. Statland, M.D.,Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number: K012462

Device Name: Theken Sement Restrictor

1. Indications for Use:
  The Theken Large Cement Restrictor is designed to occlude the medullary canal before the introduction of acrylic cement during surgeries such as total hip arthroplasty, as well as prevent cement from flowing down the diaphysis thereby facilitating cement pressurization. The Theken Large Cement Restrictor is NOT intended for any spinal indications.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
(per 21 CFR 801.109)

	Over-The-Counter Use ______
	(Optional Format 1/2/96)

for Mark N Millman

(Division Sign-Off)

Division of General Restorative and Neurological Devices

510(k) Number	K012462
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Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.