(113 days)
Not Found
No
The 510(k) summary describes a mechanical hip prosthesis and its intended use and performance testing. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
No
This device is an implantable prosthesis (femoral stem) used to replace the proximal femur in total hip arthroplasty, and its function is structural replacement rather than therapeutic in the sense of treating a disease or condition with active intervention.
No
This device is a Zimmer M/L Taper Hip Prosthesis, which is a modular, titanium alloy femoral stem designed to replace the proximal femur in total hip arthroplasty. It is a prosthetic implant, not a diagnostic tool.
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 diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (a hip prosthesis) designed to be surgically placed within the human body to replace a damaged hip joint. Its intended use is to treat conditions causing severe hip pain and disability.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens outside of the body.
Therefore, based on the provided information, the Zimmer M/L Taper Hip Prosthesis is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disoular 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; 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
LZO, MEH
Device Description
The Zimmer M/L Taper Hip Prosthesis is a modular, titanium alloy femoral stem designed to replace the proximal femur in total hip arthroplasty. It is flat, collarless and features a proximal-to-distal taper in the mediolateral (M/L) plane. The wedgeshaped prosthesis is designed for cementless use and is circumferentially porous-coated with titanium alloy plasma spray over the proximal body region. A subset of the subject devices are coated with Calcicoat hydroxyapatite tricalcium phosphate coating (HA/TCP) over the porous coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral head, 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 performance testing demonstrated that the M/L Taper Hip Prosthesis meets performance requirements. Performance testing performed included proximal fatigue testing to ISO 7206-6 and distal fatigue testing to ISO 7206-4. Bacterial endotoxin testing was conducted and met the endotoxin limits as described in USP39-NF34 Chapter 161.
Clinical data and conclusions were not needed for this device.
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
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 26, 2016
Zimmer, Inc. Ms. Rhonda Myer Project Manager. Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581
Re: K161830
Trade/Device Name: Zimmer M/L Taper Hip Prosthesis Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, MEH Dated: September 23, 2016 Received: September 26, 2016
Dear Ms. Myer:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Image /page/1/Picture/8 description: The image shows the name "Mark N. Melkerson -S" in a simple, sans-serif font. The text is horizontally aligned and appears to be part of a document or label. The letters are clear and legible, with consistent spacing between them.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K161830 (Page 1 of 1)
Device Name M/L Taper Hip Prosthesis
Indications for Use (Describe)
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disoular necrosis of thefemoral 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; 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Rhonda Myer
Project Manager, Regulatory Affairs
Telephone: (574) 371-9659
Fax: (574) 372-4710 |
| Date: | June 30, 2016 |
| Trade Name: | M/L Taper Hip Prosthesis |
| Product Code / Device: | LZO - Prosthesis, Hip, Semi-Constrained,
Metal/Ceramic/Polymer, Cemented or Non-Porous,
Uncemented |
| | MEH - Prosthesis, Hip, Semi-Constrained,
Uncemented, Metal/Polymer, Non-Porous,
Calcium-Phosphate |
| Regulation Number / Description: | 21 CFR § 888.3353 - Hip joint
metal/ceramic/polymer semi-constrained cemented
or nonporous uncemented prosthesis. |
| Predicate Device: | M/L Taper Hip Prosthesis, K032726 (cleared
October 22, 2003) and K042337 (cleared November
4, 2004) |
| Device Description: | The Zimmer M/L Taper Hip Prosthesis is a
modular, titanium alloy femoral stem designed to
replace the proximal 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. |
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and is circumferentially porous-coated with titanium alloy plasma spray over the proximal body region. A subset of the subject devices are coated with Calcicoat hydroxyapatite tricalcium phosphate coating (HA/TCP) over the porous coating.
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, protrusion 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.
Comparison to Predicate Device:
Intended Use:
The subject M/L Taper Hip Prosthesis is identical to the predicate devices in design, material, geometry, plasma spray and HA/TCP coatings. The subject device is packaged and sterilized using the same materials and processes as the predicate devices. The subject device also has the same intended use, indications for use, and fixation methods as the predicate devices. The only differences between the subject and predicate devices are the changes in the manufacturing process, which include using a forged blank instead of a wrought blank, using mass disc finishing in addition to hand polishing, and a change to the laser etch type and location.
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Performance Data (Nonclinical and/or Clinical):
Non-clinical performance testing demonstrated that the M/L Taper Hip Prosthesis meets performance requirements. Performance testing performed included proximal fatigue testing to ISO 7206-6 and distal fatigue testing to ISO 7206-4. Bacterial endotoxin testing was conducted and met the endotoxin limits as described in USP39-NF34 Chapter 161.
Clinical data and conclusions were not needed for this device.