(229 days)
P810020
Not Found
No
The summary describes a bone cement and its mechanical properties, with no mention of AI or ML.
Yes
The device is used for fixation of prosthetic implants to living bone in arthroplastic procedures, which aims to treat a medical condition (joint issues) by securing an implant. Therefore, it serves a therapeutic purpose.
No
The device is described as an acrylic bone cement used for the fixation of prosthetic implants to bone, not for diagnosing medical conditions.
No
The device description explicitly states it is an acrylic bone cement, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that PALABOND is for "fixation of polymer or metallic prosthetic implants to living bone" in arthroplastic procedures. This is a surgical procedure performed directly on a patient's body.
- Device Description: The description confirms it's an "acrylic bone cement for use in orthopedic surgery." Bone cement is a material used during surgery to secure implants.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to diagnose diseases or conditions.
PALABOND is a medical device used in vivo (within the living body) during surgery, not a test performed in vitro (outside the living body) on a sample.
N/A
Intended Use / Indications for Use
PALABOND 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
LOD
Device Description
PALABOND® 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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
PALACOS® R BONE CEMENT PMA Number: P810020
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.”
0
ADDreviated JTV(K)
Palabond®
.FEB 2 6 2003
Image /page/0/Picture/3 description: The image shows the word "Heraeus" in a bold, sans-serif font. The letters are black and stand out against a white background. The word is presented in a straightforward, unadorned manner, emphasizing its clarity and readability. The overall impression is one of simplicity and directness.
510(k) Summary
022251
page 1 of 1
| Applicant's name and address | Heraeus Kulzer GmbH & Co. KG
Grüner Weg 11
D-63450 Hanau |
|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact persons | Dr. K.-D. Kühn
phone: +49 6081 959-264
fax: +49 6081 959-288
klaus-dieter.kuehn@heraeus.com |
| | Dr. C. Tuchscherer
phone: +49 6081 959-278
fax: +49 6081 959-288
christian.tuchscherer@heraeus.com |
| Date of summary | 28.5.2002 |
| Device trade name | PALABOND® |
| Classification name | Bone Cement |
| Identification of the marketed device Palacos® to
which equivalence is claimed | PALACOS® R BONE CEMENT
PMA Number: P810020 |
| Description of the device | Palabond® 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 | Fixation of prostheses in the bone (partial or total
hip joint replacement at the hip, knee or other
joints). |
| Comparison of technological characteristics | Palabond® is chemically identical to the well
known Palacos® R being marketed for more than
25 years implicating the same biocompatibility.
The only difference is the addition of bigger
particles (granules) of copolymer to the powder.
The mechanical performance is equivalent (see test
report). |
Heraeus Kulzer GmbH & Co. KG, KULZER:, Bereich Medizin, Dr. Klaus-Dieter Kühn
Image /page/0/Picture/8 description: The image shows the words "Heraeus Kulzer" stacked on top of each other. The text is white and the background is black. The font is a serif typeface.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2003
Dr. K.D. Kuhn Heraeus Kulzer GmbH & Co. KG Gruner Weg 11 D-63450 Hanau
Re: K022251 Trade Name: Palabond Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: December 12, 2002 Received: December 16, 2002
Dear Dr. K.D. Kuhn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
2
Page 2 - Dr. K.D. Kuhn
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Mark McMullen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number (if known): K022251
Device Name: PALABOND®
Indications For Use:
PALABOND 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Martha N. Milliken
ivision A Carano Restorative and Neurological
Number
Koadas
(Optional Format 3-10-98)