(38 days)
No
The 510(k) summary describes a physical orthopedic implant (cement restrictor) and a material change. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
Explanation: The device is a cement restrictor used in orthopedic surgeries, not a therapeutic device designed for treating or curing a disease or medical condition. Its purpose is to restrict bone cement during surgery.
No
The device is described as a "cement restrictor" used in orthopedic surgeries. Its function is to restrict bone cement, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a physical implant made of PEEK OPTIMA™ and tantalum wires, intended for surgical implantation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use as a cement restrictor in orthopedic surgeries, specifically in the femoral canal and tibial plateau. This is a surgical implant used in vivo (within the body) during a procedure.
- Device Description: The description details a physical implant made of titanium alloy or PEEK, designed to restrict bone cement. This is a mechanical device, not a diagnostic tool that analyzes samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), using reagents, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Fortitude Cement Restrictor System does not fit this definition.
N/A
Intended Use / Indications for Use
The Fortitude Cement Restrictor System is intended for use 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
JDK
Device Description
Fortitude, cleared as a cement restrictor via K021719, is currently crafted from titanium alloy (ASTM F136). The purpose of this special 510(k) is to obtain clearance to market a PEEK OPTIMA™ (polyaryletheretherketone, ASTM F2026) version of Fortitude. The modification does not change the intended use or the fundamental scientific technology of the device.
As PEEK OPTIMA™ is radiolucent, radiographic markers are included in the distal and proximal ends of the PEEK implants. The markers consist of tantalum wires (ASTM F560) that are press fit into small holes in the implant.
Fortitude is a hollow device with texture on two opposing flat sides, and is offered in straight and tapered styles of various sizes. Fortitude is intended for restriction of bone cement in the distal femoral canal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral canal and tibial plateau
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic surgeries
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)
No mechanical tests were performed to support this application.
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
K031837
JUL 2 4 2003
Spinal Concepts, Inc. Fortitude™ Cement Restrictor
510(k) Summary
| SUBMITTED BY | Spinal Concepts, Inc.
5301 Riata Park Court, Bldg. F
Austin, TX 78727 | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT
REGISTRATION NUMBER | 1649384 | |
| CONTACT PERSON | Primary
Lisa Peterson
Regulatory Affairs Specialist
Phone: 512-533-1080
Fax: 512-249-6734 | Alternate
David M. Hooper, Ph.D.
Director, Clinical and
Regulatory Affairs
Phone: 512-533-1038
Fax: 512-249-6734 |
| DATE PREPARED | June 10, 2003 | |
| CLASSIFICATION NAME | Prosthesis, Hip, Cement Restrictor | |
| COMMON NAME | Cement Restrictor | |
| PROPRIETARY NAME | Spinal Concepts Inc. Fortitude™ Cement Restrictor | |
DEVICE DESCRIPTION
Fortitude, cleared as a cement restrictor via K021719, is currently crafted from titanium alloy (ASTM F136). The purpose of this special 510(k) is to obtain clearance to market a PEEK OPTIMA™ (polyaryletheretherketone, ASTM F2026) version of Fortitude. The modification does not change the intended use or the fundamental scientific technology of the device.
As PEEK OPTIMA™ is radiolucent, radiographic markers are included in the distal and proximal ends of the PEEK implants. The markers consist of tantalum wires (ASTM F560) that are press fit into small holes in the implant.
Fortitude is a hollow device with texture on two opposing flat sides, and is offered in straight and tapered styles of various sizes. Fortitude is intended for restriction of bone cement in the distal femoral canal (see figure below).
1
KOJI EOT Jage 2/2
INDICATIONS:
The Fortitude Cement Restrictor System is intended for use 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.
MECHANICAL TEST DATA
No mechanical tests were performed to support this application.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Public Health Service
JUL 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa Peterson Regulatory Affairs Specialist Spinal Concepts, Inc. 5301 Riata Park Court, Building F Austin, Texas 78727
K031837 Re: Trade Name: Fortitude™ Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: June 10, 2003 Received: June 24, 2003
Dear Ms. Peterson:
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.
3
Page 2 - Ms. Lisa Peterson
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,
Daniel Schultz, M.D.
Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number (if known):___|(03 |837 ... ...
... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ...
... ... ... ... ... ... ... ... ... ..
Spinal Concepts, Inc. Fortitude™ Cement Restrictor Device Name:
Indications for Use: The Fortitude Cement Restrictor is intended for use 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.
f. Mark A. Milliken
ision Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number K031837
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: (Per 21 CFR 801.109) 1/2/96)
OR
Over-The-Counter (Optional Format