(67 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of the bone cement, with no mention of AI or ML.
Yes
The device is described as bone cement used in arthroplasty procedures to fix prosthetic parts to living bone, which is a physical therapeutic intervention.
No
Explanation: The device is a bone cement used for fixation of prosthetic parts in arthroplasty procedures, which is a therapeutic rather than diagnostic function.
No
The device is a bone cement, which is a physical material used in surgery, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fix prosthetic parts to bone during surgery. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a bone cement used for fixation in orthopedic surgery. It doesn't mention any testing of samples from the human body for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
PALACOS® fast R+G is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary. The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
Product codes
LOD, MBB
Device Description
PALACOS® fast R+G is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone. The antibiotic gentamicin sulphate has been added to protect the cured cement and contiguous tissue against contamination by microbes sensitive to gentamicin. PALACOS® fast R+G is available in 51 g packaging size.
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)
To characterize PALACOS® fast R+G compared to the predicate device PALACOS® G performance testing of compressive strength, bending strength, bending modulus, cyclic fatigue, tensile properties, creep, shear, fracture toughness, intrusion, shrinkage and mixing and application behavior was performed according to the FDA's Guide: "Class II special controls Guidance Document: Polymethylmethacrylate (PMMA) Bone cement; Guidance for Industry and FDA". All obtained data fulfill the pre-defined acceptance criteria. Bacterial endotoxins have been evaluated using bacterial endotoxin test method (LAL test; known as the Limulus amebocyte lysate test), in accordance with USP [85] and ANSI/AAMI ST72:2011. Test results meet the endotoxin limits for the BET: 20 endotoxin units (EU)/Device recommended by FDA guidance “Pyrogen and Endotoxins Testing: Questions and Answers” (2012).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Heraeus Medical GmbH Ute Greiner Head of Regulatory Affairs Philipp-Reis-Strasse 8/13 Wehrheim, 61273 Germany
Re: K190766
Trade/Device Name: PALACOS® fast R+G Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD, MBB Dated: March 26, 2019 Received: April 1, 2019
Dear Ute Greiner:
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, 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
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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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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. Assistant Director DHT6C: Division of Stereotaxic, Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name PALACOS® fast R+G
Indications for Use (Describe)
PALACOS® fast R+G is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary. The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
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)
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Image /page/3/Picture/0 description: The image shows the logo for Heraeus, a German technology company. Below the logo is the text "Heraeus Medical GmbH" followed by the address "61273 Wehrheim, Germany". The logo and text are in a simple, sans-serif font and are arranged in a clear and legible manner. The image is likely a cropped portion of a larger document or website.
PALACOS®fast R+G
Radiopaque bone cement with gentamicin
Traditional 510(k) K190766
| 510(k) Summary | |
|---|---|
| Date of summary | May 27, 2019 |
| Applicant's name and | |
| address | Heraeus Medical GmbH |
| Philipp-Reis-Straße 8/13 | |
| 61273 Wehrheim | |
| Germany | |
| Contact person | Dr. Astrid Lößner |
| Phone: + 49 (0) 6181.35-2963 | |
| Fax: + 49 (0) 6181.35-2947 | |
| Regulatory_HM@heraeus.com | |
| Device trade name | PALACOS® fast R+G |
| Common name | PMMA Bone Cement |
| Classification | PMMA Bone Cement: Class II special control per 21 |
| CFR 888.3027 | |
| Classification name | Polymethylmethacrylate (PMMA) bone cement |
| Device code | LOD, MBB |
| Identification of the | |
| marketed device to which | |
| equivalence is claimed | PALACOS® G, K031673 |
| Description of the device | PALACOS® fast R+G is an acrylic bone cement for |
| use in orthopedic surgery. It is formed from powder | |
| and liquid by exothermic polymerization. It secures | |
| the fixation of the grafted artificial joint improving the | |
| transfer of forces at the interface implant - bone. The | |
| antibiotic gentamicin sulphate has been added to | |
| protect the cured cement and contiguous tissue | |
| against contamination by microbes sensitive to | |
| gentamicin. PALACOS® fast R+G is available in 51 g | |
| packaging size. | |
| Indications for use | PALACOS® fast R+G is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary. The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared. |
| Comparison of technological characteristics | Bone cement is derived by mixing a powder component and a monomer liquid. PALACOS® fast R+G is composed of the same materials as PALACOS® R+G. However, the BPO content and the monomer liquid:powder ratio have been modified to produce a cement with a shortened setting time compared to PALACOS® R+G. |
| Discussion of preclinical tests | To characterize PALACOS® fast R+G compared to the predicate device PALACOS® G performance testing of compressive strength, bending strength, bending modulus, cyclic fatigue, tensile properties, creep, shear, fracture toughness, intrusion, shrinkage and mixing and application behavior was performed according to the FDA's Guide: "Class II special controls Guidance Document: Polymethylmethacrylate (PMMA) Bone cement; Guidance for Industry and FDA". All obtained data fulfill the pre-defined acceptance criteria. Bacterial endotoxins have been evaluated using bacterial endotoxin test method (LAL test; known as the Limulus amebocyte lysate test), in |
| accordance with USP [85] and ANSI/AAMI | |
| ST72:2011. Test results meet the endotoxin limits | |
| for the BET: 20 endotoxin units (EU)/Device | |
| recommended by FDA guidance “Pyrogen and | |
| Endotoxins Testing: Questions and Answers” | |
| (2012). | |
| Clinical performance data | No clinical data was provided. |
| Conclusions from | |
| preclinical data | PALACOS® fast R+G is substantial equivalent to |
| PALACOS® G. |
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Image /page/4/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a large, bold, sans-serif font at the top. Below that, in a smaller, bold font, is the text "Heraeus Medical GmbH" followed by the address "61273 Wehrheim, Germany".
PALACOS®fast R+G
Radiopaque bone cement with gentamicin
510(k) Summary
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Image /page/5/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The logo consists of the word "Heraeus" in a large, bold font, followed by the text "Heraeus Medical GmbH" and the address "61273 Wehrheim, Germany" in a smaller font. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and products.
PALACOS®fast R+G
Radiopaque bone cement with gentamicin