QUANTUM CEMENT RESTRICTOR

K040276 · Quantum Orthopedics · JDK · Apr 30, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040276
• Device Name: QUANTUM CEMENT RESTRICTOR
• Applicant: Quantum Orthopedics
• Product Code: JDK · General, Plastic Surgery
• Decision Date: Apr 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Quantum Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, or humerus. This device is not intended for spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.

Device Story

Quantum Cement Restrictor; box-shaped implant with holes for bone cement retention; exterior teeth prevent migration. Available in multiple sizes for patient-specific anatomy. Materials: titanium, PEEK, or ceramic. Used by surgeons in orthopedic procedures (femur, tibia, humerus) to restrict bone cement flow during joint replacement or fixation. Device provides physical barrier to ensure proper cement mantle formation; improves surgical outcomes by preventing cement extrusion into unintended areas.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Box-shaped geometry with retention holes and anti-migration teeth. Materials: titanium, PEEK, or ceramic. Available in multiple sizes. Mechanical fixation via teeth. No energy source or software.

Indications for Use

Indicated for use as a cement restrictor in the femur, tibia, or humerus. Contraindicated for spinal use.

Regulatory Classification

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.

Submission Summary (Full Text)

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APR 3 0 2004

510(k) Summary Quantum Cement Restrictor

510(k) Number K046276

| Manufacturer Identification | |
|-----------------------------|--------------------------------------------------|
| Submitted by: | Quantum Orthopedics, Inc. |
| | 32896 Saint Moritz Drive |
| | Evergreen, CO 80439 |
| | 303-679-8895 |
| Contact Information: | Jason Blain |
| | Chief Technology Officer |
| | Quantum Orthopedics, Inc. |
| | 11662 Corte Guera |
| | San Diego, CA 92128 |
| | 858-451-8698 |
| | [e-mail] |
| Date Prepared: | February 4, 2004 |
| Device Indentification | |
| Proprietary Name: | Quantum Cement Restrictor |
| Common Name: | Cement Restrictor |
| Classification Name: | Surgical Mesh/Prosthesis, Hip, Cement Restrictor |

# Predicate Devices

The subject device is substantially equivalent to proviously cleared devices.

## Device Description

The Quantum Ccment Restrictor is a generally box-shaped device with various holes located throughout its geometry to hold bone cement. The exterior surface of the device has teeth to help kecp the device from migrating once placed in its desired location. It is available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient. The device may be made from titanium, polyetheretherketone (PEEK), or ceramic materials.

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#### Intended Use of the Device

The Quantum Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, or humerus.

This device is not intended for spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established

### Substantial Equivalence

The Quantum Cement Restrictor was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 2004

Mr. Jason Blain Chief Technology Officer Quantum Orthopedics, Inc. 11662 Corte Guera San Diego, California 92128

Re: K040276

> Device Name: Quantum Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: February 4, 2004 Received: February 6, 2004

Dear Mr. Blain:

We have reviewed your Section 510(k) pre-market 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. Jason Blain

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours

Daniel G. Schultz, M.D.

Director Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known): K040276

Device Name: Quantum Cement Restrictor

#### Indications For Use:

The Quantum Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, or humerus.

This device is not intended for spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

> Concurrence of C of Device Evaluation (ODE) RH. Office

Mark H. Milken
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

**510(k) Number** K041027 Page 1 of 1