K Number
K030904
Device Name
PALAMED
Date Cleared
2003-09-23

(183 days)

Product Code
Regulation Number
888.3027
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Palamed* 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.
Device Description
Palamed® 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.
More Information

Not Found

No
The description focuses on the chemical and mechanical properties of bone cement, with no mention of AI or ML.

Yes
The device is a bone cement used in arthroplastic procedures to fix prosthetic implants to living bone, directly improving the function of a diseased or damaged body part.

No
The device, Palamed®, is an acrylic bone cement used for the fixation of prosthetic implants to bone during orthopedic surgery. It is a therapeutic device, not a diagnostic one, as it does not diagnose a condition but rather facilitates a treatment.

No

The device description clearly 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 it's for "fixation of polymer or metallic prosthetic implants to living bone" in surgical procedures. This is a direct interaction with the patient's body during surgery, not a test performed on a sample taken from the body.
  • Device Description: It's described as an "acrylic bone cement" used in "orthopedic surgery." This further reinforces its use as a material implanted or used directly on the patient during a procedure.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis or monitoring based on in vitro testing.

IVD devices are designed to be used outside the body to examine specimens obtained 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

Palamed® 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

Palamed® 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K010586

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

(גוויר מחום מחום חשובות מחו

SEP 2 3 2003

Image /page/0/Picture/3 description: The image shows the word "Heraeus" in a bold, sans-serif font. Below the word "Heraeus" is the alphanumeric code "K030904" in a handwritten-style font. The text is black against a white background. The image appears to be a label or identifier.

510(k) Summary

| 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 | March 19th, 2003 |
| Device trade name | PALAMED® |
| Classification name | Bone Cement |
| Identification of the marketed device Palamed® to
which equivalence is claimed | PALAMED®
510k (Merck) K010586 |
| Description of the device | Palamed® 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 | This is the already known Palamed® marketed by
Merck. |

Image /page/0/Picture/7 description: The image contains the text "Heraeus Kulzer" stacked on top of each other. The text is in a serif font and is white against a black background. The word "Heraeus" is on top, and "Kulzer" is below it.

1

Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo features a stylized image of a bird with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is text that reads "INSTITUTE OF HEALTH & HUMAN SERVICES - USA". The text is arranged along the perimeter of the circle.

Public Health Service

SEP 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. K. D. Kühn Head of Department Heraeus Kulzer GmbH & Co. KG Grüner Weg 11 Hanau, Germany D-63450

Re: K030904 Trade/Device Name: PALAMED® Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: June 25, 2003 Received: July 14, 2003

Dear Dr. Kühn:

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.

2

Page 2 - Dr. K. D. Kühn

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 contact the Office of Compliance at (301) 594-4659. 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/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark N. Milkman

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

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Palamed®

ાડ

Intended Use

··

Palamed* 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.

Mark N. Milliman

(Division Sign-Off) Division of General, Restorative and Neurological Devices

K030904 510(k) Number ________________________________________________________________________________________________________________________________________________________________