(35 days)
No
The summary describes a mechanical hip implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a hip prosthesis used for revision hip arthroplasty when conservative methods have failed to provide relief, indicating its use in treating a medical condition.
No
The ZMR Hip System is described as a modular femoral stem intended for cementless use in revision hip arthroplasty, not for diagnosing conditions.
No
The device description clearly states it is a modular femoral stem manufactured from Tivanium® Ti-6Al-4V Alloy, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cementless revision hip arthroplasty." This is a surgical procedure performed on a patient's body.
- Device Description: The device is a "modular femoral stem" used in hip surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVDs are used for diagnostic purposes by analyzing samples outside the body. This device is a surgical implant used inside the body for treatment.
N/A
Intended Use / Indications for Use
The ZMR* Hip Prosthesis is intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur.
The ZMR Hip System is indicated for cementless revision hip arthroplasty. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief or when there is progressive disability.
Product codes
LPH, LZO, LWJ
Device Description
Like its predicates, the ZMR® Hip System-XL prosthesis is a modular femoral stem manufactured from Tivanium® Ti-6Al-4V Alloy and intended for cementless use in revision hip arthroplasty. This device has two modular junctions: a head/neck junction and a midstem junction. Three components are intraoperatively assembled to construct the device: a proximal "body," a distal stem, and a compression nut.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral head, neck, or portions of the proximal femur
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)
Non-clinical performance testing demonstrated that the device is equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a large, bold letter "Z" inside of a circle, followed by the word "zimmer" in lowercase letters. The "Z" is black, and the word "zimmer" is also black.
JUN 2 4 2003
Special 510(k): Device Modification
ZMR® Hip System-XL
Summary of Safety and Effectiveness
Submitter:
Contact Person:
Date:.
Trade Name:
Common Name:
Classification Name
and Reference:
Predicate Devices:
Device Description:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Karen Cain Manager, Regulatory Affairs Telephone: (574) 372-4219 Fax: (574) 372-4605
May 16, 2003
ZMR® Hip System-XL
Total hip prosthesis
Hip joint metal/polymer semiconstained uncemented prosthesis, no 21 CFR reference
Hip joint metal/polymer/metal semiconstrained porous coated uncemented prosthesis, 21 CFR 888.3358
ZMR® Hip System-Revision Taper, manufactured by Zimmer, Inc., K992667, cleared October 27, 1999
ZMR® Hip System-Porous Revision, manufactured by Zimmer, Inc., K994286, cleared March 10, 2000
Like its predicates, the ZMR® Hip System-XL prosthesis is a modular femoral stem manufactured from Tivanium® Ti-6Al-4V Alloy and intended for cementless use in revision hip arthroplasty. This device has two modular junctions: a head/neck junction and a midstem junction. Three components are intraoperatively assembled to construct the device: a proximal "body," a distal stem, and a compression nut.
K031572
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1
Image /page/1/Picture/0 description: The image contains the logo for Zimmer. The logo consists of a stylized letter "Z" enclosed in a circle, followed by the word "zimmer" in a lowercase, bold, sans-serif font. The logo is black and white.
Intended Use:
The ZMR* Hip Prosthesis is intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur.
Comparison to Predicate Device:
The modifications to the ZMR® Hip System change neither the intended use nor the fundamental scientific technology of the device. The ZMR XL components are manufactured, packaged and sterilized using the same processes and materials.
Performance Data:
Non-clinical performance testing demonstrated that the device is equivalent to the predicate.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zimmer, Inc. % Mr. Daniel Williman Associate Project Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
FEB - 3 2012
Re: K031572 Trade/Device Name: ZMR™ Hip System-XL Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, LZO, LWJ Dated: May 16, 2003 Received: June 3, 2003
Dear Mr. Williman:
This letter corrects our substantially equivalent letter of June 24, 2003.
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 (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 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.
3
Page 2 - Mr. Daniel Williman
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K031572
Device Name:
ZMR® Hip System – XL
Indications for Use:
The ZMR Hip System is indicated for cementless revision hip arthroplasty. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief or when there is progressive disability.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
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)
i
(Division Sign-Off) Division o Surgical, Orthopedic, and Restorative Devices
510(k) Number K031572
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