(27 days)
K033382, P960001/S1
No
The summary describes a bone cement and modifications to its presentation and formulation, with no mention of AI or ML.
Yes
The device is a bone cement used in total joint arthroplasty, which is a medical procedure to treat a condition or disease (joint degeneration/infection).
No
The device, DePuy CMW 1 Gentamicin Bone Cement, is described as a self-curing cement used to secure prostheses to bone during a two-stage revision for total joint arthroplasty, and its indicated use is after an infection has already been cleared. Its function is to facilitate the physical attachment of a prosthesis, not to diagnose a condition or disease.
No
The device description clearly states it is a "self-curing cement" and involves "formulation of the bone cement liquid component," 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 to secure a prosthesis to bone during a surgical procedure (total joint arthroplasty). This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description clearly states it's a "self-curing cement" used for "seating and securing" a prosthesis. This aligns with a surgical implant material, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This bone cement does not fit that description.
N/A
Intended Use / Indications for Use
DePuy CMW 1 Gentamicin Bone 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
MBB
Device Description
DePuy 1 Gentamicin Bone Cement is a self-curing cement. The cement allows the seating and securing of a metal or plastic prosthesis to living bone. The following modifications are being made:
. DePuy CMW 1 Gentamicin will be made available in a 20 gram presentation in addition to the previously cleared 40 gram presentation.
. Changes are being made to the formulation of the bone cement liquid component.
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 Gentamicin Bone Cement (K041656)
Reference Device(s)
SmartSet GMV Endurance Gentamicin Bone Cement (K033382), SmartSet MV Endurance Bone cement (P960001/S1)
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
| | NOV 2 2 2005
SUMMARY OF SAFETY AND EFFECTIVENESS | K053002 |
|--------------------------------------|-----------------------------------------------------------------------------------------------|---------|
| NAME OF FIRM: | DePuy Orthopaedics, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, IN 46581-0988 | |
| 510(k) CONTACT: | Natalie S. Heck
Manager, Regulatory Affairs | |
| TRADE NAME: | DePuy CMW 1 Gentamicin Bone Cement | |
| COMMON NAME: | Polymethyl Methacrylate (PMMA) Bone Cement with
Antibiotic. | |
| CLASSIFICATION: | Class II; 21 CFR 888.3027 | |
| DEVICE PRODUCT CODE: | MBB | |
| SUBSTANTIALLY EQUIVALENT
DEVICES: | DePuy 1 Gentamicin Bone Cement (K041656)
(now branded DePuy CMW 1 Gentamicin Bone Cement). | |
| | SmartSet GMV Endurance Gentamicin Bone Cement
(K033382). | |
| | SmartSet MV Endurance Bone cement (P960001/S1)
(previously branded Endurance Bone Cement) | |
DEVICE DESCRIPTION:
DePuy 1 Gentamicin Bone Cement is a self-curing cement. The cement allows the seating and securing of a metal or plastic prosthesis to living bone. The following modifications are being made:
- . DePuy CMW 1 Gentamicin will be made available in a 20 gram presentation in addition to the previously cleared 40 gram presentation.
- . Changes are being made to the formulation of the bone cement liquid component.
INTENDED USE AND INDICATIONS:
DePuy CMW 1 Gentamicin Bone 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.
BASIS OF SUBSTANTIAL EQUIVALENCE:
Based on similarities in formulations, manufacturing methods and intended use, DePuy believes that DePuy CMW 1 Gentamicin Bone Cement is substantially equivalent to the previously cleared and approved bone cements.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
NOV 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Natalie Heck Manager, Regulatory Affairs Depuy Orthopaedics, Inc PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K053002
Trade/Device Name: Depuy CMW 1 Gentamicin Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: MBB Dated: October 24, 2005 Received: October 27, 2005
Dear Ms. Heck:
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 - Natalie Heck
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 (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,
Signature: Mark N. Miller
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications Statement
510(k) Number (if known):
Device Name: DePuy CMW 1 Gentamicin Bone Cement
Indications for Use:
DePuy CMW 1 Gentamicin Bone 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.
Prescription Use (Part 21 CFR 801.Subpart D)
OR/AND
Over-The Counter Use (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)
Page 1 of
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
1053002 510(k) Number.