(27 days)
Not Found
No
The document describes a physical implant (a cement restrictor) made of titanium and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is a cement restrictor used in orthopedic surgeries. Its function is mechanical, not therapeutic in the sense of treating a disease or condition through biological, pharmacological, or radiative means.
No
Explanation: The device is described as a cement restrictor used in orthopedic surgeries for hip and knee replacement. Its function is to physically restrict cement flow, not to diagnose medical conditions or provide information for diagnosis.
No
The device is described as a physical, titanium block intended for use in orthopedic surgery, clearly indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "cement restrictor in orthopedic surgeries in the femur and tibia in hip and knee replacement." This describes a surgical implant used in vivo (within the body) during a surgical procedure.
- Device Description: The device is described as a "tapered block that is titanium" and is intended to be used "in conjunction with standard PMMA cement." This further reinforces its role as a physical component used during surgery.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The description of this device does not involve any of these activities.
Therefore, the Medtronic Sofamor Danek Block Cement Restrictor (CR) - Titanium is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The BLOCK CR-Titanium 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.
The BLOCK CR-Titanium is NOT intended for any spinal indications.
Product codes
JDK
Device Description
The BLOCK CR - TITANIUM is a tapered block that is titanium. The device is intended to be used in conjunction with standard PMMA cement.
The BLOCK CR - TITANIUM implants are manufactured from titanium alloy as described by ASTM F136 or ISO 5832-3.
The purpose of this submission is to obtain clearance for the alternative design. All other aspects of the device including material, indications for use, and fundamental scientific technology are the same as the previous cleared TITANIUM CEMENT RESTRICTOR.
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
K01-3014
OCT - 4 2001
Image /page/0/Picture/2 description: The image contains the word "CONFIDENTIAL" in large, bold, sans-serif font. The letters are black and appear to be printed on a white background. The word is slightly tilted to the right.
BLOCK CEMENT RESTRICTOR (CR) - TITANIUM 510(k) Summary September 2001
Medtronic Sofamor Danek USA, Inc. I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Proposed Proprietary Trade Name: II.
BLOCK CR - TITANIUM
III. Device Description:
The BLOCK CR - TITANIUM is a tapered block that is titanium. The device is intended to be used in conjunction with standard PMMA cement.
The BLOCK CR - TITANIUM implants are manufactured from titanium alloy as described by ASTM F136 or ISO 5832-3.
The purpose of this submission is to obtain clearance for the alternative design. All other aspects of the device including material, indications for use, and fundamental scientific technology are the same as the previous cleared TITANIUM CEMENT RESTRICTOR.
IV Intended Use:
The BLOCK CR-Titanium 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.
The BLOCK CR-Titanium is NOT intended for any spinal indications.
Substantial Equivalence: V.
The BLOCK CR - TITANIUM was demonstrated to be substantially equivalent to previously cleared devices such as TITANIUM CEMENT RESTRICTOR (K003718). A Design Review for the device was provided in this submission.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 4 2001
Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K013014 Block Cement Restrictor (CR) - Titanium Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: September 5, 2001 Received: September 7, 2001
Dear Dr. Treharne:
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.
2
Page 2 - Richard W. Treharne, Ph.D.
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.
Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number: K013014
Medtronic Sofamor Danek Block Cement Restrictor (CR) - Titanium Device Name:
FDA's Statement of the Indications For Use for Device:
The Medtronic Sofamor Danek Block Cement Restrictor (CR) - Titanium is intended for use as a cement restrictor in orthopedic surgeries in the femur and tibia in hip and knee replacement.
The Block CR-Titanium is NOT intended for any spinal indications.
for Mark n Mulkerson
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number. __ K013014
Prescription Use OR (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________