(94 days)
P810020
No
The summary describes a bone cement and does not mention any AI or ML components or functionalities.
No
Explanation: A therapeutic device is designed to treat a disease or condition. This device is an acrylic bone cement used for fixation of artificial joints, which is a supportive function during surgery rather than a direct treatment of a disease or condition.
No
The device description clearly states it is an acrylic bone cement used to secure the fixation of grafted artificial joints, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is an acrylic bone cement, which is a physical material used in surgery, 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 securing the fixation of an artificial joint in orthopedic surgery. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an acrylic bone cement used to fix implants to bone. This is a material used in vivo (within the living body).
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information about a patient's health status, diagnose conditions, or monitor treatment. The description of PALACOS® LV + G does not involve any of these activities.
Therefore, PALACOS® LV + G is a medical device used in surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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® LV + 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Reference Device(s)
PMA P810020 1998
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)
Palacos LV®+ G
Image /page/0/Picture/3 description: The image shows the word "Heraeus" in a bold, sans-serif font. The text appears to be slightly distressed or textured, giving it a vintage or worn look. The letters are evenly spaced and the word is horizontally aligned.
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510(k) Summary
| Mar 29th, 2005 | |
|---|---|
| Date of summary | |
| Device trade name | PALACOS® LV + G |
| Common Name | PMMA Bone Cement |
| Classification name | Bone Cement, 888.3027 |
| Identification of the marketed device to which | |
| equivalence is claimed | OSTEOPAL® K030903 |
| PMA P810020 1998 | |
| Description of the device | Palacos® LV + 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. | |
| Intended use | 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 | The only difference to Osteopal is the additional |
| gentamicin. The cement performs most similar to | |
| Osteopal. | |
| Submitted by | Dr. C. Tuchscherer |
| phone: +49 6081 959-278 | |
| fax: +49 6081 959-252 | |
| christian.tuchscherer @heraeus.com |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
JUL 7 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Christian Tuchscherer Heraeus Kulzer GmbH Division Heraeus Medical Phillip Reis-Strasse 8/13 Wehrheim, Germany - D-61273
Re: K050854
Trade/Device Name: Palacos® LV + G Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD and MBB Dated: March 30, 2005 Received: April 7, 2005
Dear Dr. Tuchscherer:
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, iisting 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.
2
Page 2 – Dr. Christian Tuchscherer
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 it you attent 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,
Hupt Rhodes
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: PALACOS® LV + G
Indications For Use:
PALACOS® LV + G is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
Prescription Use yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use no (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styt Rlurlie
Page 1 of 1
(Division Sign-Off Division of General, Restorative. and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________