(28 days)
Not Found
No
The summary describes a purely mechanical device made of PEEK for restricting bone cement. There is no mention of software, algorithms, or any technology that would suggest AI/ML.
No.
This device is a cement restrictor used in orthopedic surgeries to hold bone cement (PMMA) in the diaphyseal canal. It is a surgical accessory and does not directly provide therapy or treatment for a disease or condition itself.
No
This device is described as a "cement restrictor" used to "hold bone cement (PMMA) in the diaphyseal canal in patients requiring a cemented arthroplasty device." It is an implant used during orthopedic surgery, not a tool for diagnosing medical conditions.
No
The device description explicitly states it is a "hollow device with teeth on two opposing flat sides" crafted of PEEK, indicating it is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Cadence PEEK Cement Restrictor System is a physical device implanted inside the body during orthopedic surgery. Its function is to physically restrict bone cement within the femoral canal or tibial plateau.
- Intended Use: The intended use clearly states it's for use in orthopedic surgeries as a cement restrictor. This is a surgical implant, not a diagnostic test.
The information provided about the device's description, intended use, anatomical site, and predicate device all point to it being a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Cadence™ PEEK 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 (comma separated list FDA assigned to the subject device)
JDK
Device Description
The Cadence™ PEEK Cement Restrictor is a hollow device with teeth on two opposing flat sides, offered in a tapered style of various sizes. The device is crafted of PEEK (ASTM F136). The device is used to hold bone cement (PMMA) in the diaphyseal canal in patients requiring a cemented arthroplasty device.
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
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.
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
| Submitted By: | Spinal Concepts, Inc.
12012 Technology Blvd., Suite 100
Austin, TX 78727
512-918-2700
October 25, 2002 | NOV 27 2002 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Audrey Swearingen
Regulatory Affairs Specialist | |
| Trade Name: | Cadence™ PEEK Cement Restrictor | |
| Proposed Classification Name: | Prosthesis, Hip, Cement Restrictor | |
| Product Code: | JDK (21CFR 878.3300) | |
510(K) Summary of Safety and Effectiveness
Device Description: The Cadence™ PEEK Cement Restrictor is a hollow device with teeth on two opposing flat sides, offered in a tapered style of various sizes. The device is crafted of PEEK (ASTM F136). The device is used to hold bone cement (PMMA) in the diaphyseal canal in patients requiring a cemented arthroplasty device.
Intended Use: The Cadence™ PEEK 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 spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.
Substantial Equivalence: The Spinal Concepts, Inc. Cadence™ PEEK Cement Restrictor was demonstrated to be substantially equivalent to the Spinal Concepts Cadence™ Titanium Cement Restrictor (K022218).
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines forming a silhouette. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
. Dr. David Hooper Manager, Clinical & Regulatory Affairs Spinal Concepts Incorporated 12012 Technology Blvd. Suite 100 Austin, Texas 78727
K023647 Trade Name: Cadence™ PEEK Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: October 28, 2002 Received: October 30, 2002
Dear Dr. Hooper:
Re:
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.
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
2
Page 2 - Dr. David Hooper
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,
Alan Webb for Dan Schultz
David C. Schultz, MD
Daniel G. Schultz, MD Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEME
Page 1 of 1
510(k) Number (if known):
Device Name: Spinal Concepts, Inc. Cadence™ PEEK Cement Restrictor
Indications for Use:
The Cadence PEEK 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use: (Per 21 CFR 801.109) Over-The-Counter: (Optional Format 1-2-96)
(Optional Format 1-2-96)
Mark J. Miller
(Division Sign-Off) Dirision of General, Restorative ano Neurological Devices