(37 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a bone cement, with no mention of AI or ML technologies.
Yes.
The device is a bone cement used to fix pathological fractures and provide rapid pain relief, indicating a therapeutic purpose.
No
Explanation: The device is a bone cement used for fixation of fractures, not for diagnosing medical conditions.
No
The device is a bone cement, which is a physical material used in surgical procedures. The description details its chemical composition, physical properties, and packaging, all of which are characteristic of a hardware medical 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 for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a bone cement, a material implanted into the body.
- Lack of In Vitro Testing: The performance studies described are non-clinical tests evaluating the physical and chemical properties of the cement itself, not tests performed on biological samples in vitro (outside the body) to diagnose or monitor a condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This bone cement does not fit that description.
N/A
Intended Use / Indications for Use
The COHESION Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
Product codes (comma separated list FDA assigned to the subject device)
NDN
Device Description
The purpose of this submission is to submit a new bone cement that is a modification of Vertecem and Opacity+ bone cements, previously cleared on K090435 and K080873, respectively. Cohesion has the same indications for use as the predicate devices. Another similarity is that the 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. Cohesion is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. Like its predicates Cohesion allows an excellent consolidation of the vertebral body and an effective and rapid pain relief.
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)
Non-clinical Test Summary: The following tests were conducted: Chemical Composition, Powder morphology, Molecular weights, handling times, Compressive strength, Dynamic fatgue test compression, Flexural strength, Flexural modulus, Viscosity or extrusion forces during the injection phase, Setting time vs. temperature, Radiopacity, Monomer elution testing. Test data indicate that the final properties of Cohesion 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. Clinical Test Summary: No clinical studies were performed.
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
§ 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 for the Cohesion Bone Cement
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Cohesion Bone Cement
Date Prepared: December 20, 2010
K1.03816
FEB - 4 2011
- Submitter: Teknimed SAS 11 rue Apollo Z.I. Montredon 31240 L'Union France
Contact Person: J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199
~~2:~~Trade name: Cohesion Bone Cement Common Name: Classification Name:
Polymethylmethacrylate (PMMA) bone cement Cement, Bone, Vertebroplasty Class II per 21 CFR section 888.3027 NDN
3. Predicate or legally marketed devices which are substantially equivalent:
Cohesion is a modification of the following bone cements: Vertecem (K090435, Teknimed) Opacity+ (K080873, Teknimed) Spine-Fix® (K045593, Teknimed)
Description of the device: 4.
The purpose of this submission is to submit a new bone cement that is a modification of Vertecem and Opacity+ bone cements, previously cleared on K090435 and K080873, respectively. Cohesion has the same indications for use as the predicate devices. Another similarity is that the 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. Cohesion is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. Like its predicates Cohesion allows an excellent consolidation of the vertebral body and an effective and rapid pain relief.
Materials:
The liquid component is mainly composed of methyl methacrylate. The major powder components are polymethylmethacrylate (PMMA). Benzoyl peroxide which initiates the polymerization is included in the polymer powder.
Substantial equivalence claimed to predicate devices 5.
Cohesion is substantially equivalent to the Vertecem, Opacity+ and Spine-Fix® in terms of intended use, design, materials used, mechanical safety and performances. The table below compares the features and characteristics of the Cohesion to these predicate devices.
| Device
Name
| Items | Cohesion | Vertecem | Opacity+ | Spine-Fix® |
|---|---|---|---|---|
| Sponsor | Teknimed | Teknimed | Teknimed | Teknimed |
| 510(k) Number | -- | K090435 | K080873 | K045593 |
| Device Classification | ||||
| Name | Cement, Bone, | |||
| Vertebroplasty | Cement, Bone, | |||
| Vertebroplasty | Cement, Bone, | |||
| Vertebroplasty | Cement, Bone, | |||
| Vertebroplasty | ||||
| Product Code | NDN | NDN | NDN | NDN |
| Regulation # | Class II per 21 CFR | Class II per 21 CFR | Class II per 21 CFR | Class II per 21 CFR |
1
| Device
| Name | Cohesion | Vertecem | Opacity+ | Spine-Fix® |
|---|---|---|---|---|
| Items | ||||
| section 888.3027 | section 888.3027 | section 888.3027 | section 888.3027 | |
| Indications for Use | see below | same | same | same |
| Chemical Composition | PMMA based w/ | |||
| methylmethacrylate | PMMA based w/ | |||
| methylmethacrylate | PMMA based w/ | |||
| methylmethacrylate | PMMA based w/ | |||
| methylmethacrylate | ||||
| Compressive strength | per ISO 5833 | per ISO 5833 | per ISO 5833 | per ISO 5833 |
| Dynamic testing | performed | performed | performed | performed |
| Flexural strength | per ISO 5833 | per ISO 5833 | per ISO 5833 | per ISO 5833 |
| Flexural modulus | per ISO 5833 | per ISO 5833 | per ISO 5833 | per ISO 5833 |
6. Intended Use:
The Cohesion is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
The Vertecem Bone Cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
The Opacity+ is intended for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
Spine Fix cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Non-clinical Test Summary: 7.
The following tests were conducted:
- · Chemical Composition
- . Powder morphology
- . Molecular weights
- handling times .
- Compressive strength .
- . Dynamic fatgue test compression
- Flexural strength .
- Flexural modulus .
- · Viscosity or extrusion forces during the injection phase
- . Setting time vs. temperature
- Radiopacity .
- . Monomer elution testing
Test data indicate that the final properties of Cohesion 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.
Clinical Test Summary: 8.
No clinical studies were performed
Conclusions Nonclinical and Clinical: 9.
The Cohesion Cement is substantially equivalent to Vertecem, Opacity+ and Spine-Fix®. The modifications do not change the intended use or fundamental scientific technology of the device and do not raise any new issues of safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Teknimed SAS % The OrthoMedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock. Texas 78681
FEB - 4 201
Re: K103816
Trade/Device Name: Cohesion Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: December 20, 2010 Received: January 07, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
.
. . . . . . . . .
:
3
Page 2 - Mr. J.D. Webb
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutfDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: COHESION Bone Cement
Indications For Use:
The COHESION Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103816