(90 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of bone cement, with no mention of AI or ML.
Yes
The device, bone cement, is intended to fix prosthetic implants to living bone during arthroplastic procedures, which directly treats a medical condition (joint issues requiring prosthetic implants).
No
The device is a bone cement intended for fixation of prosthetic implants to bone in arthroplastic procedures, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a PMMA, radiopaque bone cement, which is a physical material used for fixation, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "fixation of polymer or metallic prosthetic implants to living bone" in surgical procedures. This is an in-vivo application (within the living body), not an in-vitro application (outside the living body, typically involving testing of samples like blood or tissue).
- Device Description: The description details a bone cement that is mixed and hardens to fix implants. This is a material used directly in surgery, not a diagnostic test performed on a sample.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This bone cement does not fit that description.
N/A
Intended Use / Indications for Use
Hi-Fatigue Bone Cement 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.
Product codes (comma separated list FDA assigned to the subject device)
LOD
Device Description
Hi-Fatique Bone Cement is a PMMA, radiopaque bone cement, designed for the fixation of prothesis to the living bone. Hi-Fatigue Bone Cement is a traditional bone cement product. The bone cement is made of two separate sterile components. When both components are mixed together, they become a self-hardening, radiopaque bone cement which fixes the implant. The liquid is contained in a vial and the powder in a pouch; these components are packed in blister with Tyvek lid or an aluminium pouch. The devices are sold disposable, single-use and sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, knee and other joints
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 performance testing was performed to characterize the bone cements in accordance with special controls guidance document. This testing included the following:
- Mixing and Application characteristics (e.g. dough time, setting time, viscosity, intrusion )
- Chemical Composition (e.q. trace elements, residual low MW molecules, leachables)
- Molecular weight and Polymer structure (e.g. molecular weight, glass transition temperature)
- Physical Properties (e.g. porosity, shrinkage)
- Stability of Components (e.g. change in monomer viscosity due to artificial aging)
- Thermal Properties (e.g. maximum polymerization temperature)
- Mechanical properties (e.g. cyclic fatique properties, bending properties, compressive properties, tensile properties, fracture toughness)
The performance data demonstrate that the new devices Hi-Fatigue Bone Cement is substantially equivalent to the predicate device Palacos® R 510(k) application K030902 and meet the requirements of the Special Controls Guidance document.
Bacterial endotoxins of Hi-Fatique Bone Cement have been evaluated using Recombinant Factor C Assay (EndoZyme) following Ph. Eur. 5.01.10 and 2.06.14, based on USP and USP. Test results meet the endotoxin limits of 20 endotoxin units (EU)/device as defined in USP and as recommended by the FDA guidance "Pyrogen and Endotoxins Testing: Question and Answers" (2012).
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
OSARTIS GmbH Volker Stirnal Director, Ouality Assurance and Regulatory Affairs Lagerstrasse 11-15 Dieburg, 64807 Germany
Re: K192394
Trade/Device Name: Hi-Fatigue Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD Dated: August 30, 2019 Received: September 3, 2019
Dear Mr. Stirnal:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne, Ph.D. Acting Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K192394
Device Name Hi-Fatigue Bone Cement
Indications for Use (Describe)
Hi-Fatigue Bone Cement 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Hi-Fatigue Bone Cement 510(k) Summary K192394
1. General Information
1.1 Submitter and Owner of the 510(k)
OSARTIS GmbH Lagerstraße 11-15 64807 Dieburg Germany Phone: +49 6071 / 929-0 Fax: +49 6071 / 929-100
1.2 Contact Person
Volker Stirnal
1.3 Device Subject of this 510(k)
Hi-Fatigue Bone Cement
1.4 Date of Preparation
28.10.2019
2. Name of the Device and Classification Information
This traditional 510(k) has been submitted for the following device.
Hi-Fatigue Bone Cement
2.1 Trade/Proprietary Name
Hi-Fatique Bone Cement
2.2 Common/Usual Name
PMMA bone cement for orthopedics
2.3 Classification Information
Classification Name: Polymethylmethacrylate (PMMA) Bone Cement
Classification Regulation: 21 CFR § 888.3027
Regulatory Class: Class II
Product Code: LOD - Bone Cement
Orthopedic Panel:
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Hi-Fatigue Bone Cement
510(k) Summary
3. Predicate Device
The predicate devices are as follows:
4. Device Description
Hi-Fatique Bone Cement is a PMMA, radiopaque bone cement, designed for the fixation of prothesis to the living bone. Hi-Fatigue Bone Cement is a traditional bone cement product. The bone cement is made of two separate sterile components. When both components are mixed together, they become a self-hardening, radiopaque bone cement which fixes the implant. The liquid is contained in a vial and the powder in a pouch; these components are packed in blister with Tyvek lid or an aluminium pouch. The devices are sold disposable, single-use and sterile.
5. Indication for Use
Below is the indication for use:
Hi-Fatigue Bone Cement 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.
6. Comparison of the technological Characteristics with the Predicate Device
Hi-Fatigue Bone Cement shares many of the same technological characteristics compared to the predicates Palacos® R and Cobalt™ MV Bone Cement, including important considerations such as most materials.
| Characteristics | | Hi-Fatigue G
Bone Cement | Palacos® R
K030902 | Cobalt™ MV
Bone Cement
K091608 |
|--------------------|---------------------|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------------------|
| Material
powder | Polymer | Poly (methyl
acrylate/methyl
methacrylate)
(PMMA)
Poly (methyl
methacrylate/styr
ene) | Poly (methyl
acrylate/methyl
methacrylate)
(PMMA) | Poly (methyl
methacrylate)
Methyl
methacrylate-
Styrene |
| | Initiator | Benzoyl peroxide | Benzoyl peroxide | Benzoyl peroxide |
| | Radio-
pacifier | Zirconium dioxide | Zirconium dioxide | Zirconium dioxide |
| | Colour
Additives | None | Chlorophyll VIII | FD&C Blue No. 2
Aluminium Lake |
| Material
Liquid | Monomer | Methylmethacrylat
e (MMA) stabilized
with Hydroquinone | Methylmethacrylat
e (MMA) stabilized
with Hydroquinone | Methylmethacrylat
e stabilized with
Hydroquinone |
Table 1: Comparison of the Technological Characteristics with the Predicate Devices
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Hi-Fatique Bone Cement
510(k) Summary
| Characteristics | Hi-Fatigue G Bone Cement | Palacos® R K030902 | Cobalt™ MV Bone Cement K091608 |
|---|---|---|---|
| Activator | N,N-dimethyl-p-toluidine | N,N-dimethyl-p-toluidine | N,N-dimethyl-p-toluidine |
| Colour Additives | None | Chlorophyll VIII in oily solution | None |
7. Performance Data
This 510(k) submission provided performance data to establish the substantial equivalence of the new bone cements to the predicate bone cement. Performance testing was conducted in accordance with the "FDA Class II Special Controls Guidance Document: Polymethylacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002.
Non-clinical performance testing was performed to characterize the bone cements in accordance with special controls guidance document. This testing included the following:
- Mixing and Application characteristics (e.g. dough time, setting time, viscosity, intrusion )
- Chemical Composition (e.q. trace elements, residual low MW molecules, leachables)
- Molecular weight and Polymer structure (e.g. molecular weight, glass transition temperature)
- Physical Properties (e.g. porosity, shrinkage)
- Stability of Components (e.g. change in monomer viscosity due to artificial aging)
- Thermal Properties (e.g. maximum polymerization temperature)
- Mechanical properties (e.g. cyclic fatique properties, bending properties, compressive properties, tensile properties, fracture toughness)
The performance data demonstrate that the new devices Hi-Fatigue Bone Cement is substantially equivalent to the predicate device Palacos® R 510(k) application K030902 and meet the requirements of the Special Controls Guidance document.
Bacterial endotoxins of Hi-Fatique Bone Cement have been evaluated using Recombinant Factor C Assay (EndoZyme) following Ph. Eur. 5.01.10 and 2.06.14, based on USP and USP. Test results meet the endotoxin limits of 20 endotoxin units (EU)/device as defined in USP and as recommended by the FDA guidance "Pyrogen and Endotoxins Testing: Question and Answers" (2012).