(79 days)
Not Found
No
The document describes a mechanical hip implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a hip prosthesis, which is used to replace a damaged hip joint and restore function, thereby treating a medical condition.
No
The device description clearly states it is a "femoral stem" and a "prosthesis" for hip arthroplasty, which are surgical implants, not diagnostic tools.
No
The device description clearly states it is a 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 to replace a hip joint.
- Device Description: The device is a "femoral stem straight femoral stem" and related components, which are physical implants used in 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 patient's health status.
IVDs are typically tests, reagents, instruments, or systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ZMR Revision Taper 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
The ZMR Revision Taper Hip Prosthesis is a femoral stem straight 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 headthess k junction and a midstem junction. Three components are intraoperatively assembled to construct the device: a proximal segment or "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
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Key Metrics
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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
K 992667
P.O. Box 708
OCT 2 7 1999
Image /page/0/Picture/2 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter "Z" inside, and the word "zimmer" written in lowercase letters below the circle. The letter "Z" and the word "zimmer" are both in a bold, sans-serif font.
Warsaw, IN 46581-0708 Summary of Safety and Effectiveness 219 267-6131
-
Submitted By: .
Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 219-267-6131 -
. Contact Person:
Karen Cain Regulatory Affairs Associate 219/372-4219 Telephone: 219/372-4605 Fax: -
. Date:
August 2, 1999 -
Trade Name: ●
ZMRTM Hip System-Revision Taper -
Common Name: .
Femoral Hip Prosthesis -
Classification Name: ●
Hip joint metal/polymer semiconstrained uncemented prosthesis -
Predicate Devices: .
Image /page/0/Picture/21 description: The image shows a geometric design with a hexagonal shape. The hexagon is divided into six equal triangular sections. Each triangular section contains a smaller triangle pointing inward, creating a star-like pattern within each section. The design is symmetrical and appears to be a repeating pattern or a stylized symbol.
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Summary of Safety and Effectiveness (Continued)
Device Description
●
The ZMR Revision Taper Hip Prosthesis is a femoral stem straight 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 headthess k junction and a midstem junction. Three components are intraoperatively assembled to construct the device: a proximal segment or "body," a distal stem, and a compression nut.
. Intended Use
The ZMR Revision Taper 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 Devices
All hip systems listed above are substantially cquivalent to cach other and the ZMR Revision Taper Hip Prosthesis in that each is intended for cementless fixation into the intramedullary canal for pathological or degenerative conditions involving the femur and/or acetabulum. All predicate devices feature a Morse-type proximal neck taper that mates with a femoral head which, in turn, articulates upon the ultraching molecular-weight polyethylene (UHMWPE) bearing surface of a total hip or hemihip acctabular component. All predicate devices are manufactured from necell alloys that have a history of successful clinical use in orthopaedic applications.
RA07901K.510
2
Image /page/2/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure. The figure is composed of three wavy lines that form the silhouette of a person's head and shoulders. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the emblem in a circular fashion.
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: K992667 Trade/Device Name: ZMRTM Hip System- Revision Taper 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: August 2, 1999 Received: August 9, 1999
Dear Mr. Williman:
This letter corrects our substantially equivalent letter of October 27, 1999.
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.
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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/Resourcesfor You/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
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Indications for Use
510(k) Number (if known): K992667
Device Name:
ZMR® Hip System - Revision Taper
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)
Duerf
sion Sion-l vicion of Surgical, Orthopedic, and nostorative Devices
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510(k) Number K992667