(57 days)
Not Found
No
The device description and intended use describe a purely mechanical implant for orthopedic surgery. There is no mention of software, data processing, or any technology that would suggest AI/ML.
No.
The device is a cement restrictor used in orthopedic surgeries to hold bone cement, not to treat or cure a disease or medical condition.
No
The device is a cement restrictor used during orthopedic surgeries to hold bone cement. It does not gather information about a patient's health or disease state.
No
The device description clearly states it is a physical implant made of titanium alloy or PEEK, not software.
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 orthopedic surgeries" for procedures like hip stem and total knee replacement. This is a surgical implant used in vivo (within the body) during a medical procedure.
- Device Description: The description details a physical implantable device made of titanium or PEEK, designed to hold bone cement within the body.
- Anatomical Site: The specified anatomical sites (femoral canal and tibial plateau) are internal body locations.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. This device is a surgical tool/implant used directly within the body during a procedure.
N/A
Intended Use / Indications for Use
The Spinal USA Cement Restrictor System is intended as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
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.
Product codes
IDK, JDK
Device Description
The Spinal USA Cement Restrictor is a hollow rounded rectangular frame with various holes located throughout its geometry to hold bone cement. The exterior surface of the device has teeth on two opposing flat sides to prevent migration. The device comes in various sizes and is offered in straight and tapered styles. The device may be made from titanium alloy as specified in ASTM F136 or polyetheretherketone (PEEK) that conforms to ASTM F2026-02.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral canal and tibial plateau in hip stem and total knee replacement
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR 1 6 2006
510 (k) Summary of Safety and Effectiveness
| Date Summary Prepared: | January 16, 2006 |
|---|---|
| Submitter Information: | Spinal USA |
| 213 Eastside Lane | |
| Brandon, MS 39047 | |
| Contact Name: | Jeffrey Johnson |
| Phone: | 601-992-7668 |
| Fax: | 601-992-0380 |
| E-mail: | jeff@spinalusa.com |
| Device Trade Name: | Spinal USA Cement Restrictor System |
| Common Name: | Prosthesis, Hip, Cement Restrictor |
| Regulatory Number: | 878.3300 |
| Classification: | Class II |
| Product Code: | IDK |
INTENDED USE:
The Spinal USA Cement Restrictor System is intended as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
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.
DEVICE DESCRIPTION:
The Spinal USA Cement Restrictor is a hollow rounded rectangular frame with various holes located throughout its geometry to hold bone cement. The exterior surface of the device has teeth on two opposing flat sides to prevent migration. The device comes in various sizes and is offered in straight and tapered styles. The device may be made from titanium alloy as specified in ASTM F136 or polyetheretherketone (PEEK) that conforms to ASTM F2026-02.
EQUIVALENT DEVICE:
The Spinal USA Cement Restrictor System was demonstrated to be substantially equivalent to previous cleared devices such as the Scient'X Cement Restrictor (K052367), Quantum Cement Restrictor (K040276), and Fortitude Cement Restrictor (K021719). The subject device and predicate devices have the following similarities:
-the same indication for use
-the same operating principle
-the same basic design
-the same materials
-implanted using the same surgical techniques and equipment
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and head, and two curved lines representing its legs. The seal is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 2006
Spinal USA C/o Mr. Jeffrey Johnson Manager, Regulatory Affairs 213 Eastside Lane Brandon, Mississippi 39047
Re: K060132
K000192
Trade/Device Name: Spinal USA Cement Restrictor System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: JDK Dated: January 16, 2006 Received: January 19, 2006
Dear Mr. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 3 rots) presidentially equivalent (for the indications ferenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the clerosure) to regally manage of the Medical Device Amendments, or to commerce provide to may 20, 1978, are excerdance with the provisions of the Federal Food, Drug, devices that have been reclassified in accerative while in a premarket approval application (PMA). and Cosmetic Act (Act) that to not require apt to the general controls provisions of the Act. The 1 ou may, mercere, manel are as not include requirements for annual registration, listing of general controls provisions of wactice, labeling, and prohibitions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this The Office or Device Evanuation has avot identified in the proposed labeling and that such use device with be used for an mosiose cordance with Section 513(i)(1)(E) of the Act, the following court cause namin. "Therefore, namings 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.
2
Page 2 - Mr. Jeffrey Johnson
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. r teast note that the act to aconing before these limitations are modified in any way or removed from the device's labeling.
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 Ietter will allow you to begin marketing your device as described in your Section 510(k) icter will anow you to began minutes on statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elassified (800 are rols. Existing major regulations affecting your device can may be subject to subli additions, 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 I that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You taust of any I catales and 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 CI IT art 007); idocing (21 (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. product from to begin marketing your device as described in your Section 510(k) I mis letter will and w yours ough finding of substantial equivalence of your device to a legally prematice notification: "The PDF interessification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you attire of Compliance at (240) 276-0120. 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 oner general minternational 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 vours.
Herbert Lemmer
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 3 - Mr. Jeffrey Johnson
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Enclosure
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4
K 060132
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Spinal USA Cement Restrictor System
Indications for Use:
The Spinal USA Cement Restrictor System is intended as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
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.
Prescription Use
(Part 21 CFR 801 Subpart D)
X
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert Lemon
Division Division of General, Restorative. and Neurological Devices
510(k) Number K060132