(83 days)
Not Found
No
The 510(k) summary describes a mechanical hip prosthesis and does not mention any software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The Zimmer Anatomic II Hip Prosthesis is an implantable device used to replace a hip joint during total hip arthroplasty, which is a surgical procedure to address severe hip pain and disability. While it treats a medical condition, it does so through mechanical replacement rather than by restoring or improving a physiological function in the way a therapeutic device for rehabilitation or ongoing treatment might.
No
Explanation: The device described is a hip prosthesis, which is an implant used for treating various hip conditions, not for diagnosing them. Its purpose is to replace part of the hip joint, not to identify or characterize diseases.
No
The device description clearly describes a physical implant (femoral stem) made of metal alloy, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Zimmer Anatomic II Hip Prosthesis is a surgical implant designed to replace a damaged hip joint. It is a physical device inserted into the body during surgery.
- Intended Use: The intended use describes treating conditions like arthritis and fractures by replacing the hip joint, not by analyzing samples from the body.
The provided information clearly describes a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Zimmer Anatomic II Hip Prosthesis is indicated for:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
- Patients suffering from disability due to previous fusion.
- Patients with acute femoral neck fractures.
Product codes
LPH
Device Description
The Zimmer Anatomic II Hip Prosthesis is an anatomically shaped femoral stem for use in total hip arthroplasty. It is manufactured from Tivanium® Ti-6Al-4V Alloy and utilizes a modular junction between the head and neck. Biological fixation is achieved with the use of a Tivanium Ti-6A1-4V plasma spray coating. The modular connection of the femoral stem is a Morse-type 12/14 taper designed to mate with the corresponding femoral head component. Zimaloy® Co-Cr-Mo Alloy femoral heads are available for use with the femoral stem or, where available, Alumina Ceramic Femoral Heads. The modified Zimmer Anatomic Stems have been developed to increase surgeons' options so that they may meet the large variety of anatomical needs of their patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip (femoral head, femoral neck, hip)
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
Non-Clinical Performance and Conclusions: Non-clinical performance testing demonstrated that the modified device is equivalent to the predicate.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Key Metrics
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/1 description: The image contains a logo with the word "zimmer" next to a circular graphic. The graphic contains a stylized letter "Z" inside of a circle. The text is in a simple, sans-serif font and is black on a white background.
KO41109 (pg 10f 2) JUL 2 0 2004 Summary of Safety and Effectiveness Submitter: Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708 Contact Person: Dalene T. Binkley Associate, Regulatory Affairs Telephone: (574) 372-4907 Fax: (574) 372-4605 Date: April 27, 2004 Zimmer & Anatomic II Hip Prosthesis Trade Name: Common Name: Prosthesis, Hip, Semi-constrained, Metal/Polymer, Porous, Uncemented Classification Name LPH and Reference: 21 CFR § 888.3358 Predicate Device: Zimmer Anatomic Hip Prosthesis, manufactured by Zimmer, K922071, cleared February 22, 1994. Device Description: The Zimmer Anatomic II Hip Prosthesis is an anatomically shaped femoral stem for use in total hip arthroplasty. It is manufactured from Tivanium® Ti-6Al-4V Alloy and utilizes a modular junction between the head and neck. Biological fixation is achieved with the use of a Tivanium Ti-6A1-4V plasma spray coating. The modular connection of the femoral stem is a Morse-type 12/14 taper designed to mate with the corresponding femoral head component. Zimaloy® Co-Cr-Mo Alloy femoral heads are available for use with the femoral stem or, where available, Alumina Ceramic Femoral Heads. The modified Zimmer Anatomic Stems have been developed to increase surgeons' options so that they may meet the large variety of anatomical needs of their patients.
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Image /page/1/Picture/0 description: The image contains the word "zimmer" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized "Z" inside. The logo and the word "zimmer" are both in black, contrasting with the white background.
2 of 2 6041109 (pa
| Intended Use: | The Zimmer Anatomic II Hip Prosthesis is
indicated for:
- Patients suffering from severe hip pain and
disability due to rheumatoid arthritis, osteoarthritis,
traumatic arthritis, polyarthritis, collagen disorders,
avascular necrosis of the femoral head, and
nonunion of previous fractures of the femur. - Patients with congenital hip dysplasia, protrusio
acetabuli, or slipped capital femoral epiphysis. - Patients suffering from disability due to previous
fusion. - Patients with acute femoral neck fractures. |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicate Device: | The modifications to the Zimmer Anatomic Hip
Prosthesis change neither the intended use nor the
fundamental scientific technology of the device. It
is packaged and sterilized using the same materials
and processes. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
Non-clinical performance testing demonstrated that
the modified device is equivalent to the predicate.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for
this device. |
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Dalene T. Binkley, RAC Associate, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
JUL 2 0 2004
Re: K041109
Trade Name: Zimmer® Anatomic II Hip Prosthesis Regulation Numbers: 21 CFR 888.3358 Regulation Names: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II
Product Codes: LPH Dated: June 25, 2004 Received: June 28, 2004
Dear Ms. Binkley:
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. Dalene T. Binkley
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,
Mark A. Milburn
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
4041109
Indications for Use
510(k) Number (if known):
Device Name:
Zimmer® Anatomic II Hip Prosthesis
Indications for Use:
The Zimmer Anatomic II Hip Prosthesis is indicated for:
- The Zimmer Anatome if Thip Prost.ioie w to rheumatoid arthritis, anchis surfering from beverb mp pacitatitis, collagen disorders, avascular necrosis of Usevaluntilis, fraumatio and nonunion of previous fractures of the femur.
- the remoral nead, and nonamon of pia, protrusio acetabuli, or slipped capital femoral epiphysis.
- Patients suffering from disability due to previous fusion. -
- Patients with acute femoral neck fractures. -
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)
L. Mark N. Mulkern
(Division Sign-Off Division of General, Restorative, and Neurological Devices
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510(k) Number K041109