(85 days)
Not Found
Not Found
No
The description focuses on the physical characteristics and materials of a mechanical device (cement restrictor) and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
No
The device is a cement restrictor, used to hold bone cement in place during surgeries on the femur, tibia, or humerus, which is an accessory to a therapeutic procedure rather than a therapeutic device in itself.
No
Explanation: The device is described as a "cement restrictor" used in orthopedic procedures to hold bone cement and prevent migration. Its function is to facilitate a medical treatment (restricting cement), not to diagnose a condition.
No
The device description clearly indicates it is a physical, implantable device made from materials like titanium, PEEK, or ceramic, and has a physical form factor with features like holes and teeth. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "cement restrictor in the femur, tibia, or humerus." This describes a device used within the body during a surgical procedure to restrict the flow of bone cement.
- Device Description: The description details a physical implantable device made of materials like titanium, PEEK, or ceramic, designed to be placed in bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for conditions. This device is a surgical implant.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JDK
Device Description
The Quantum Cement 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, tibia, or humerus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 | |
| jblain@quantumorthopedics.com | |
| 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.
Image /page/1/Picture/6 description: The image shows the text "page 2 of 2" in handwritten form. The word "page" is written in lowercase cursive, followed by the number "2". The phrase "of 2" is written above and to the right of the word "page", also in handwritten form. The handwriting appears to be in black ink on a white background.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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
4
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