(31 days)
Not Found
Not Found
No
The 510(k) summary describes a physical, resorbable implant used as a cement restrictor. There is no mention of software, data processing, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is described as a cement restrictor used during joint arthroplasty to prevent cement flow and aid in pressurized filling. It is a tool used during a surgical procedure to achieve a desired mechanical outcome, not directly to treat a disease or condition in a therapeutic manner.
No
Explanation: The device is described as a "cement restrictor" intended to prevent cement flow and allow pressurized filling during joint arthroplasty. It is an implant used during a surgical procedure, not for diagnosing conditions.
No
The device description clearly states it is a "resorbable implant manufactured from a polymer-ceramic composite," indicating it is a physical 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 as a cement restrictor in the femur, tibia, and/or humerus during joint arthroplasty. This is a surgical implant used in vivo (within the body) during a procedure.
- Device Description: The description details a resorbable implant designed to be placed within the medullary canal. This is a physical device used during surgery, not a test performed on biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Interpore Cross CEMENT RESTRICTOR is intended for use as a cement restrictor in the femur, tibia and/or humerus.
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.
Product codes (comma separated list FDA assigned to the subject device)
JDK
Device Description
The Interpore Cross CEMENT RESTRICTOR is a resorbable implant manufactured from a polymer-ceramic composite. The Interpore Cross CEMENT RESTRICTOR is designed to wedge into the medullary canal during joint arthroplasty to prevent flow of cement into the canal and allow for pressurized filling of the implantation site. It is provided in various shapes and sizes as needed for particular surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, tibia and/or humerus
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.
Not Found
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).
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.
§ 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
KO32095 PAGE 1
INTERPORE CROSS CEMENT RESTRICTOR Cement Restrictor
Interpore Cross International Confidential
AUG - 8 2003
510(k) SUMMARY
SUBMITTED BY
Prosie Rev-Fessler, RAC Director, Regulatory Affairs and Ouality Assurance INTERPORE CROSS International 181 Technology Drive Irvine, California 92618
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
Classification Name: Cement Restrictor Common/Usual Name: Cement Restrictor Product Classification: Unclassified Proprietary Name: Interpore Cross CEMENT RESTRICTOR
PREDICATE DEVICES
Interpore Cross Cement Restrictor
INDICATIONS-FOR-USE
The Interpore Cross CEMENT RESTRICTOR is intended for use as a cement restrictor in the femur, tibia and/or humerus.
DEVICE DESCRIPTION
The Interpore Cross CEMENT RESTRICTOR is a resorbable implant manufactured from a polymer-ceramic composite. The Interpore Cross CEMENT RESTRICTOR is designed to wedge into the medullary canal during joint arthroplasty to prevent flow of cement into the canal and allow for pressurized filling of the implantation site. It is provided in various shapes and sizes as needed for particular surgical procedures.
COMPARISON TO THE PREDICATE DEVICE
The Interpore Cross CEMENT RESTRICTOR is substantially equivalent to the cited predicate devices based on the indications for use, design features, principles of operation and materials.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem that features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2003
Ms. Prosie Rey-Fessler, RAC Director, Regulatory and Quality Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618
K032095 Re:
Trade Name: Interpore Cross Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: July 7, 2003 Received: July 9, 2003
Dear Ms. Rey-Fessler:
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 - Ms. Prosie Rey-Fessler, RAC
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
3
510(k) Number (if known): K 032095
Device Name: INTERPORE CROSS CEMENT RESTRICTOR
Indications-For-Use:
The Interpore Cross CEMENT RESTRICTOR is indicated for use as a cement restrictor in the femur, tibia and/or humerus. 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.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Prescription Use V (PER 21 CFR 801.109) ଠାର
Over-The-Counter Use
(Optional Format 1-2-96)
Wen Witt
KOBERT
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K032095