(49 days)
Not Found
No
The 510(k) summary describes a mechanical hip prosthesis and does not mention any AI or ML components or functionalities.
No.
The document describes a Zimmer® M/L Taper Hip Prosthesis, which is a medical implant used in hip replacement surgery, not a therapeutic device in the sense of actively treating or alleviating a condition through external means. It replaces a damaged anatomical part.
No
Explanation: The device description clearly states it is a "modular, titanium alloy femoral stem designed to replace the proximal human femur in total hip arthroplasty." This indicates it is an implanted prosthetic device, not a device used to diagnose medical conditions.
No
The device description clearly states it is a "modular, titanium alloy femoral stem," which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions.
- Device Description: The description clearly states that the Zimmer® M/L Taper Hip Prosthesis is a "modular, titanium alloy femoral stem designed to replace the proximal human femur in total hip arthroplasty." This is a surgical implant, not a device that analyzes biological samples.
- Intended Use: The intended use describes the conditions for which the hip replacement is performed, which are related to musculoskeletal issues and injuries, not the analysis of biological specimens.
Therefore, based on the provided information, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged: nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
Product codes
LPH
Device Description
The Zimmer® M/L Taper Hip Prosthesis is a modular, titanium alloy femoral stem designed to replace the proximal human femur in total hip arthroplasty. It is flat, collarless, and features a proximal-to-distal taper in the mediolateral (M/L) plane. The wedge-shaped prosthesis is designed for cementless use and is circumferentially porous-coated with titanium alloy plasma spray over the proximal body region.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal human femur, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing demonstrated that the M/L Taper Hip Prosthesis met performance requirements and is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K921301, K020963, K994286, K964769
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. The logo consists of a large, bold letter "Z" inside of a circle, followed by the word "zimmer" in a smaller, sans-serif font. The letter "Z" is black, and the word "zimmer" is also black.
K032726
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Laura D. Williams, RAC
Sr. Associate, Regulatory Affairs
Telephone: (574) 372-4523
Fax: (574) 372-4605 |
| Date: | August 28, 2003 |
| Trade Name: | Zimmer® M/L Taper Hip Prosthesis |
| Common Name: | Total Hip Prosthesis |
| Classification Name | Hip joint metal/polymer/metal semiconstrained
porous coated uncemented prosthesis |
| Reference and Product Code: | 21 CFR § 888.3358, LPH |
| Predicate Device: | 1. Biomet Taperloc, K921301, cleared 2-16-94; and
K020963, cleared 4-16-02
2. Zimmer ZMR® Hip System Porous Revision,
K994286, cleared 3-10-00
3. Zimmer VerSys® Hip System Fiber Metal Taper
Hip Prosthesis, K964769, cleared 3-13-97 |
| Device Description: | The Zimmer® M/L Taper Hip Prosthesis is a
modular, titanium alloy femoral stem designed to
replace the proximal human femur in total hip
arthroplasty. It is flat, collarless, and features a
proximal-to-distal taper in the mediolateral (M/L)
plane. The wedge-shaped prosthesis is designed for
cementless use and is circumferentially porous-
coated with titanium alloy plasma spray over the
proximal body region. |
| Intended Use: | Total hip replacement for the following: severe hip
pain and disability due to rheumatoid arthritis,
osteoarthritis, traumatic arthritis, polyarthritis,
collagen disorders, avascular necrosis of the |
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Image /page/1/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" in the circle is black, and the word "zimmer" is also black.
femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip: elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
The M/L Taper Hip Prosthesis is packaged, manufactured, and sterilized using the same materials and processes as the predicate devices. The subject device also has the same intended use and fixation methods as the predicate devices.
Performance Data (Nonclinical and/or Clinical):
Comparison to Predicate Device:
Non-Clinical Performance and Conclusions:
Non-clinical testing demonstrated that the M/L Taper Hip Prosthesis met performance requirements and is as safe and effective as the predicate devices.
page 2 of 2
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, and the letters "USA" are included in the seal.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2003
Ms. Laura D. Williams, RAC Sr. Associate, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Re: K032726
Trade/Device Name: Zimmer® M/L Taper Hip Prosthesis, 7711 Series 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 Dated: September 2, 2003 Received: September 3, 2003
Dear Ms. Williams:
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. Laura D. Williams, RAC
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. Milkerson
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
Indications for Use
Page 1 of 1
510(k) Number (if known):
Device Name:
Zimmer® M/L Taper Hip Prosthesis
Indications for Use:
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged: nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
Mark N. Milkersen
Division Sign-Off) Division of General. Restorative and Neurological Devices
510(k) Number K032726
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)