(443 days)
K041584, K0032945
Not Found
No
The device description and performance studies focus on the material properties and clinical outcomes of a bone cement, with no mention of AI or ML technologies.
Yes
The device is used to fix pathological fractures and provide pain relief in vertebral compression, which directly contributes to the treatment and management of a disease or condition.
No
The device description indicates that Spine-Fix cement is used for the "fixation of pathological fractures of the vertebral body" and "allows an excellent consolidation of the vertebral body and an effective and rapid pain relief." This describes a therapeutic device used for treatment, not for diagnosing a condition.
No
The device description clearly states it is a self-hardening cement made of powder and liquid components, which are physical materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic or monitoring purposes.
- Spine Fix Cement's Intended Use: The intended use of Spine Fix cement is for the fixation of pathological fractures of the vertebral body using surgical procedures (vertebroplasty or kyphoplasty). It is a material implanted into the body to provide structural support and pain relief.
- Device Description: The description clearly states it's a self-hardening cement made of components like methyl methacrylate and polymethylmethacrylate, designed to be injected into the vertebral body.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens from the patient. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, Spine Fix cement is a surgical implant/material and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Spine Fix cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Product codes
NDN
Device Description
Spine-Fix is a self hardening and ready to use cement with a high amount of radiopaque agent for percutaneous vertebroplasty. It allows an excellent consolidation of the vertebral body and an effective and rapid pain relief.
This type of cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box. The liquid component is mainly composed of methyl methacrylate. The major powder component is polymethylmethacrylate (PMMA). Benzoyl peroxide which initiates the polymerisation is included in the polymer powder
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)
A study of 113 patients at 24 months post-op was conducted. Effectiveness was assessed whether there was improvement in neck pain and disability and whether or not the patient's ability to function in daily life was improved. Safety information was measured by the reporting of adverse events.
One hundred percent of the patients were classified as successful after this surgery. All patients reported mild or no pain at the last follow-up visit and all were classified as normal function or mildly dysfunctional. No patients reported any serious complications as a result of the surgery and all patients were alive at the last follow-up.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K041584, K0032945
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.”
0
510(k) Summary Spine-Fix® Biomimetic Bone Cement December 16, 2005
| Submitter | Teknimed S.A.
11 rue Apollo
Z.I. Montredon
31240 L'Union
France |
|---------------------|------------------------------------------------------------------------------------------------------|
| | MA |
| Contact person | J.D. Webb
1001 Oakwood Blvd
Round Rock, TX 78681
512-388-0199 |
| Trade Name | Spine-Fix® Biomimetic Bone Cement |
| Common name | Polymethylmethacrylate (PMMA) bone cement |
| Classification name | Filler, Bone Cement (for vertebroplasty)
Class II per 21 CFR section 888.3027 |
| Product Code | NDN |
| Equivalent Device | KYPHX HV-R Bone Cement, MODEL C01A (Kyphon, Inc. - K041584)
Spineplex® (Stryker Corp. - K0032945) |
Device Description
Spine-Fix is a self hardening and ready to use cement with a high amount of radiopaque agent for percutaneous vertebroplasty. It allows an excellent consolidation of the vertebral body and an effective and rapid pain relief.
This type of cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box. The liquid component is mainly composed of methyl methacrylate. The major powder component is polymethylmethacrylate (PMMA). Benzoyl peroxide which initiates the polymerisation is included in the polymer powder
Intended Use
Spine Fix cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painfull vertebral compression from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Summary Nonclinical Tests
Test data indicate that the final properties of Spine-Fix bone cement are stable and in compliance with the standard reference for bone cement: ISO 5833 "implants for surgery - acrylic resin cements" and are similar to predicate devices.
Summary Clinical Tests
A study of 113 patients at 24 months post-op was conducted. Effectiveness was assessed whether there was improvement in neck pain and disability and whether or not the patient's ability to function in daily life was improved. Safety information was measured by the reporting of adverse events.
One hundred percent of the patients were classified as successful after this surgery. All patients reported mild or no pain at the last follow-up visit and all were classified as normal function or mildly dysfunctional. No patients reported any serious complications as a result of the surgery and all patients were alive at the last follow-up.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 17 2006
Teknimed S.A.
c/o The OrthoMedix Group, Inc. ( Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K043593
Trade/Device Name: Spine-Fix® Biomimetic Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: December 16, 2005 Received: December 19, 2005
Dear Mr. Webb:
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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. J.D. Webb
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hubert Lenoir
Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological I calth
Enclosure
3
Indications for Use
র
510(k) Number (if known): (Cy35) 3
Device Name: ___Spine-Fix® Biomimetic Bone Cement
Indications for Use:
Spine Fix cement is used for the fixation of pathological fractures of the vertebral Spine Fix cellient is used for the misules. Painful vertebral compression 000y using vertebrophasty of ityphopiasy prosis (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Prescription Use _ X -(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)
Helent Lemmer
(Division Si: - Off) Division of Ceneral, Restorative, and Neurological Devices
510(k) Number K043593