(246 days)
Not Found
Not Found
No
The summary describes a bone cement and does not mention any AI or ML components or functionalities.
Yes
The device is a bone cement used for the fixation of pathological fractures of the vertebral body, making it a therapeutic device.
No
Explanation: The device is a bone cement used for fixation of pathological fractures, not for identifying or diagnosing a disease or condition.
No
The device description clearly states it is a PMMA bone cement, which is a physical material, not software.
Based on the provided information, the Spineplex™ Radiopaque Bone cement is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for the fixation of pathological fractures of the vertebral body using surgical procedures (vertebroplasty or kyphoplasty). This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a bone cement, a material implanted into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Spineplex™ cement does not interact with or analyze such specimens.
Therefore, the Spineplex™ Radiopaque Bone cement is a medical device used for surgical treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Spineplex™ Radiopaque Bone cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Product codes
LOD, NDN
Device Description
Stryker Spineplex™ Radiopaque Bone Cement is a PMMA bone cement made of the same chemical components as Stryker Simplex® P.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vertebral body
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)
Stryker Simplex® P
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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striker INSTRUMENTS 2007 წლებში 2005 წლის 2001 წლის 2001 წლის 2001 წლის 2002 წლის 2002 წლის 2002 წლებში 2000 წელს 2000 წლებში 2000 წელს 2000 წლების 20
4100 Cast Milham Avenue
Kalamazoo. MI 49001
Phone (269) 323-7700 (800) 253 3210
510(k) Summary
| Trade Name: | Stryker Spineplex™ Radiopaque Bone Cement |
|---|---|
| Common Name: | PMMA bone cement |
| Classification: | Bone Cement, 888.3027 |
| Equivalent to: | Stryker Simplex® P |
| Device Description: | Stryker Spineplex™ Radiopaque Bone Cement is a PMMA bone cement made of the same chemical components as Stryker Simplex® P. |
| Intended Use: | Spineplex™ Radiopaque Bone cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). |
| Technological Comparison: | Stryker Spineplex™ Radiopaque Bone Cement is made of the exact components a Simplex™ P. The ratio of the ingredients has been modified to increase the working time and enhance visualization of the cement to meet customer needs in the fixation of vertebral compression fractures. |
| Submitted by: | Dannielle C. Wheeler |
| Sr. Regulatory Affairs Representative | |
| Stryker Instruments | |
| Signature | |
| Date | |
| Date Submitted: | Sept. 19, 2003 |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three wavy lines, representing health and medical services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 25 2004
Ms. Dannielle Wheeler Senior Regulatory Affairs Representative Stryker Corporation Instrument Division 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K032945
Trade/Device Name: Spineplex™ Radiopaque Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: PMMA Bone Cement Regulatory Class: II Product Codes: LOD, NDN Dated: February 27, 2004 Received: March 1, 2004
Dear Ms. Wheeler:
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. Dannielle Wheeler
This letter will allow you to begin marketing your device as described in your Section 510(k) rms retect notification. The FDA finding of substantial equivalence of your device to a legally premailed 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milkeess
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K032945
Device Name: Spineplex™ Radiopaque Bone Cement
Indications for Use:
Spineplex™ Radiopaque Bone cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Mark N. Millican
Division of General, Restorative, and Neurological Devices
KO32995 510(k) Number.
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