(29 days)
Not Found
No
The summary describes a physical medical device (a tapered block) made of specific materials, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as a "cement restrictor" used in orthopedic surgeries to restrict cement, not to treat a disease or condition itself.
No
Explanation: The device is described as a "cement restrictor" used in orthopedic surgeries to restrict cement, not to diagnose a condition or disease.
No
The device description explicitly states the device is a physical, tapered block made from materials like PEEK, titanium alloy, or Polylactic Acid, intended for use as a cement restrictor in orthopedic surgery. This indicates it is a hardware device, not software.
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 is a surgical implant used in vivo (within the body) during a surgical procedure.
- Device Description: The device is described as a "tapered block" made from materials like PEEK, titanium alloy, or Polylactic Acid. It's used in conjunction with PMMA cement. This description aligns with a physical implant used during surgery.
- 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, monitor, or screen for diseases or conditions.
IVD devices are used to perform tests on biological samples to provide information about a person's health. This device is a physical component used during a surgical procedure.
N/A
Intended Use / Indications for Use
The CEMENT RESTRICTOR (CR) is intended for use as a cement restrictor in orthopedic surgeries in the femur and tibia in hip and knee replacement.
The CEMENT RESTRICTOR (CR) is NOT intended for any spinal indications.
Product codes (comma separated list FDA assigned to the subject device)
JDK
Device Description
The subject CEMENT RESTRICTOR is a tapered block that is made from POLYETHERETHERKETONE (PEEK). The device is intended to be used in conjunction with standard PMMA cement.
Implants are manufactured out of medical-grade titanium alloy such as described by ASTM F136 or ISO 5832-3. The CEMENT RESTRICTOR implants may also be manufactured from 70:30 Polylactic Acid (Poly (L-lactide-co-D, L -lactide) 70:30, amorphous). Alternatively, the entire system may be made out of POLYETHERETHERKETONE (PEEK) as described by standards such as ASTM F-2026. MEDTRONIC SOFAMOR DANEK expressly warrants that these devices are fabricated from one of the foregoing material specifications. No other warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. Do not use with implants from another manufacturer.
The purpose of this submission is to obtain clearance for the alternative material. All other aspects of the device including design, indications for use, and fundamental scientific technology are the same as the previous cleared BLOCK CEMENT RESTRICTOR-TITANIUM.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur and tibia
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.
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DEC 0 5 2001
K013663
page 1 of 1
CONFIDENTIAL
CEMENT RESTRICTOR (CR) 510(k) Summary November 2001
- Medtronic Sofamor Danek USA, Inc. . Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Proposed Proprietary Trade Name: II.
CEMENT RESTRICTOR (CR)
111. Device Description:
The subject CEMENT RESTRICTOR is a tapered block that is made from POLYETHERETHERKETONE (PEEK). The device is intended to be used in conjunction with standard PMMA cement.
Implants are manufactured out of medical-grade titanium alloy such as described by ASTM F136 or ISO 5832-3. The CEMENT RESTRICTOR implants may also be manufactured from 70:30 Polylactic Acid (Poly (L-lactide-co-D, L -lactide) 70:30, amorphous). Alternatively, the entire system may be made out of POLYETHERETHERKETONE (PEEK) as described by standards such as ASTM F-2026. MEDTRONIC SOFAMOR DANEK expressly warrants that these devices are fabricated from one of the foregoing material specifications. No other warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. Do not use with implants from another manufacturer.
The purpose of this submission is to obtain clearance for the alternative material. All other aspects of the device including design, indications for use, and fundamental scientific technology are the same as the previous cleared BLOCK CEMENT RESTRICTOR-TITANIUM.
IV. Intended Use:
The CEMENT RESTRICTOR (CR) is intended for use as a cement restrictor in orthopedic surgeries in the femur and tibia in hip and knee replacement.
The CEMENT RESTRICTOR is NOT intended for any spinal indications.
V. Substantial Equivalence:
The CEMENT RESTRICTOR was demonstrated to be substantially equivalent to previously cleared devices such as BLOCK CR-TITANIUM (K013014) and Medtronic Sofamor Danek Cement Restrictor (K010528). A Design Review for the device was provided in this submission.
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Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Richard W. Treharne Sr. Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K013663
Trade Name: Cement Restrictor (CR) Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: JDK Dated: November 5, 2001 Received: November 6, 2001
Dear Dr. Treharne:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have 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 stated in the onerobate, to regard ent date of the Medical Device Amendments, or to devices that provision in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costions of the Act and the limitations described below. The general controls provisions of the provisions of the receints 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for
DEC 0 5 2001
2
Page 2 - Dr. Richard W. Treharne
Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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
Page 1 of 1
510(k) Number (if known):__KOJ 366 ك
CEMENT RESTRICTOR (CR) Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The CEMENT RESTRICTOR (CR) is intended for use as a cement restrictor in orthopedic surgeries in the femur and tibia in hip and knee replacement.
The CEMENT RESTRICTOR (CR) is NOT intended for any spinal indications.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Evaluation (ODE)
Prescription Use _ Y = OR (Per 21 CFR 801.109) (Optional 1-2-96)
No Over-the-counter Use __
R. Mark McMullen
Division of General, Restorative and Neurological Devices
510(k) Number K013663
000034