(131 days)
Not Found
PMA N17004
No
The summary describes a bone cement and its intended use, with no mention of AI or ML technology in the device description or other sections.
No
The device, Simplex P bone cement, is used for the fixation of prostheses to living bone and pathological fractures. While it aids in procedures for certain conditions, its primary function is fixation rather than directly treating or curing a disease or condition itself.
No
Explanation: The device, Simplex P bone cement, is used for fixation of prostheses to bone or for fixation of pathological fractures. It is a material used in surgical procedures, not an instrument or system designed to identify or analyze medical conditions.
No
The device description clearly states it is a bone cement, which is a physical material, 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 for the fixation of prostheses to living bone during orthopaedic musculoskeletal procedures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a bone cement, a material used to physically bond implants to bone.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. This device does not involve the analysis of such specimens.
Therefore, Simplex P bone cement is a medical device used in a surgical context, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Simplex™ P bone cement will be indicated for fixation of prostheses to living bone during orthopaedic musculoskeletal procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, or revision of a previous Simplex™ P bone cement is also indicated for the fixation of arthroplasty. pathological fractures where loss of bone substance or recalcitrance of the fracture renders more conventional procedures ineffective.
Product codes (comma separated list FDA assigned to the subject device)
87 LOD
Device Description
Simplex™ P Bone Cement is a radiopaque bone cement capable of being applied digitally and with a syringe. The cement will be available in 10-pack or 1-pack dispensers, with each individual pack containing one 40.0g unit of sterile polymeric powder and one 20.0ml ampoule of sterile monomer, for single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
living bone
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.
PMA N17004
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
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
0
510(k) Summary of Safety and Effectiveness Simplex™ P Bone Cement
JAN - 8 2007
| Proprietary Name: | Simplex™ P Bone Cement |
|---|---|
| Common Name: | PMMA Bone Cement |
| Classification Name and Reference | Polymethylmethacrylate (PMMA) bone |
| cement | |
| 21 CFR §888.3027 | |
| Regulatory Class: | Class II |
| Device Product Code: | 87 LOD - Polymethylmethacrylate (PMMA) |
| bone cement. | |
| Device Manufacturer: | Howmedica International S. de R.L. |
| Raheen Business Park, Limerick, Ireland | |
| For Information contact: | Tiffani Rogers |
| Regulatory Affairs Specialist | |
| Stryker Orthopaedics | |
| 325 Corporate Drive | |
| Mahwah, New Jersey 07432 | |
| Phone: (201) 831-5612 | |
| Fax: (201) 831-6038 | |
| E-Mail: Tiffani.Rogers@stryker.com) | |
| Date Summary Prepared: | August 28, 2006 |
Device Description
Simplex™ P Bone Cement is a radiopaque bone cement capable of being applied digitally and with a syringe. The cement will be available in 10-pack or 1-pack dispensers, with each individual pack containing one 40.0g unit of sterile polymeric powder and one 20.0ml ampoule of sterile monomer, for single-use.
1
Indications For Use:
Simplex™ P bone cement will be indicated for fixation of prostheses to living bone during orthopaedic musculoskeletal procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, or revision of a previous Simplex™ P bone cement is also indicated for the fixation of arthroplasty. pathological fractures where loss of bone substance or recalcitrance of the fracture renders more conventional procedures ineffective.
Substantial Equivalence:
The Simplex™ P powder and liquid monomer formula have not been modified and will be the same as what was approved in PMA N17004.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Orthopaedics % Ms. Tiffani Rogers Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
JAN - 8 2007
Re: K062553
Trade/Device Name: Simplex™ P Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: November 13, 2006 Received: November 22, 2006
Dear Ms. Rogers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
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.
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Page 2 - Ms. Tiffani Rogers
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
for
Mark N. Malkerson
Mark N Aelkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications
Simplex P bone cement will be indicated for fixation of prostheses to living bone during orthopaedic musculoskeletal procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, or revision of a previous Simplex™ P bone cement is also indicated for the fixation of arthroplasty. pathological fractures where loss of bone substance or recalcitrance of the fracture renders more conventional procedures ineffective.
Prescription Use X (Per 21 CFR 801.109)
OR Over-the-Counter Use
(Please Do Not Write Below This Line - Continue on Another Page if Needed)
Polo Rz
(Division Si ""-Off) Division of General, Restorative, and Neurological Devices
510(k) Number V062553