(94 days)
Not Found
K030904 (PALAMED)
No
The summary describes a bone cement and does not mention any AI or ML capabilities.
Yes
The device is used in orthopedic surgery to secure the fixation of an artificial joint, which directly contributes to the treatment and improvement of a medical condition (total joint arthroplasty after infection).
No
Explanation: The device description states that PALAMED® G is an acrylic bone cement used to secure the fixation of grafted artificial joints, which is a therapeutic function, not diagnostic.
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 in vivo (within the body).
- Device Description: The device is an acrylic bone cement used to fix an implant to bone. This is a material used in vivo during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to be used in vitro for diagnostic purposes. This device is clearly intended for use in vivo during surgery.
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
PALAMED® 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): 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.
Not Found
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.
K030904 (PALAMED)
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
ついい(K)
Palamed® G
Image /page/0/Picture/3 description: The image shows the word "Heraeus" in a bold, sans-serif font. The text is slightly distressed, giving it a textured appearance. The word is horizontally oriented and fills the majority of the frame.
510(k) Summary
| Date of summary | Mar 29th, 2005 |
|---|---|
| Device trade name | PALAMED® G |
| Common Name | PMMA Bone Cement |
| Classification name | Bone Cement, 888.3027 |
| Identification of the marketed device to which equivalence is claimed | PALACOS® R BONE CEMENT |
| PMA Number: P810020 | |
| Description of the device | PALAMED® 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 | Palamed® G is similar to Palacos R except for the additional gentamicin sulphate and a lower initial viscosity. Palamed® G performs very similar to Palacos R. |
| See also K030904 (PALAMED). | |
| Submitted by | Dr. C. Tuchscherer |
| phone: +49 6081 959-278 | |
| fax: +49 6081 959-252 | |
| christian.tuchscherer@heraeus.com | |
| Signature | Image: Signature |
| Date |
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CC02
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 7 - 2005
Dr. Christian Tuchscherer Heraeus Kulzer GmbH Grüner Weg 11 Germany - D-63450 Hanau
Re: K050855 Trade/Device Name: Palamed® G Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD and MBB Dated: March 29, 2005 Received: April 4, 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, 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Dr. Tuchscherer
This letter will allow you to begin marketing your device as described in your Section 510(k) 1 mo letter will and the FDA finding of substantial equivalence of your device to a legally p whather 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,
Hipt Rluder
iriam 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: PALAMED® G
Indications For Use:
PALAMED® 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)
Stypa Plurdin
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
KOSO855 510(k) Number_