(376 days)
K/DEN number: Not Found
Not Found
No
The summary describes a bone cement with an antibiotic additive and does not mention any computational or data-driven features.
Yes
The device is a bone cement containing an antibiotic (Gentamicin) used in total joint arthroplasty to secure prostheses and address residual infection, which is a therapeutic function.
No
This device is a bone cement used for securing prostheses, not for diagnosing conditions.
No
The device description clearly states it is a "self curing cement" made of PMMA with Gentamicin, indicating it 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 is for securing a prosthesis to bone during a surgical procedure (total joint arthroplasty revision). This is a therapeutic and structural function performed in vivo (within the body).
- Device Description: The device is a bone cement, a material used to fix implants to bone. This is a medical device used in vivo.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens outside the body.
Therefore, DePuy 1 Gentamicin Bone Cement is a medical device used in vivo for surgical purposes, not an IVD.
N/A
Intended Use / Indications for Use
DePuy 1 Gentamicin 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
MBB, LOD
Device Description
DePuy 1 Gentamicin Bone Cement is a self curing cement, to which one gram of Gentamicin is added in 40 grams PMMA (Polymethyl methacrylate) cement for allowing the seating and securing of a metal or plastic prosthesis to living 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
DePuy 1 Bone Cement, BACTISEAL Catheter, OrthoGuard AB Antimicrobial Sleeve
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
K023103 page 1/2
510(k) Summary
DePuy 1 Gentamicin Bone Cement
DePuy, Inc. 700 Orthopaedic Drive Warsaw, IN 46581
A. Contact Person:
Cheryl K Hastings Director, Regulatory Affairs (574) 372-7006 FAX (574) 371-4987
B. Device Information:
| Proprietary Name: | DePuy 1 Gentamicin Bone Cement |
|---|---|
| Common Name: | Polymethyl methacrylate (PMMA) bone cement |
| with Antibiotic | |
| Regulatory Class and | |
| Classification Name: | Class III; no classification name has been |
| established by FDA | |
| Product Code: | MBB |
C. Indications for Use:
DePuy 1 Gentamicin is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
D. Device Description:
DePuy 1 Gentamicin Bone Cement is a self curing cement, to which one gram of Gentamicin is added in 40 grams PMMA (Polymethyl methacrylate) cement for allowing the seating and securing of a metal or plastic prosthesis to living bone.
1
K023103 page $\frac{2}{2}$
E. Substantial Equivalence:
The substantial equivalence of the DePuy 1 Gentamicin Bone Cement is demonstrated by its similarity in indications for use, design, materials, sterilization and packaging to DePuy 1 Bone Cement, the BACTISEAL Catheter (Codman) and OrthoGuard AB Antimicrobial Sleeve (Smith and Nephew).
The determination of substantial equivalence for this device was based on a detailed device description, product testing and conformance with voluntary performance standards.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures. The symbol consists of three curved lines that converge and then diverge, creating a sense of movement and dynamism.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 9 2003
Ms. Cheryl K. Hastings Director, Regulatory Affairs DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46581
Re: K023103
Trade/Device Name: DePuy 1 Gentamicin Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: June 30, 2003 Received: July 1, 2003
Dear Ms. Hastings:
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.
3
Page 2- Ms. Cheryl K. Hastings
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) 594-4639. 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 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 A. Millham
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
4
K023/03
510(k) Number (if known) Device Name
DePuy 1 Gentamicin Bone Cement
Indications for Use
DePuy 1 Gentamicin is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark n Millman
(Division Sign-Off)
(Corision Sign-Off)
Division of General, Restorative and Neuron of General, Resto and Neurological Devices
510(k) Number K023103
Prescription Use > > (Per 21 CFR §801 109)
OR
Over-the-Counter Use No
(Optional Format 1-2-96)