(113 days)
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.
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 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.
Please note that the provided text is a 510(k) summary for a medical device (Zimmer M/L Taper Hip Prosthesis), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against specific acceptance criteria for a novel AI/software medical device.
Therefore, the requested information elements related to AI/software performance studies (such as acceptance criteria, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document. The document describes a traditional medical device (hip prosthesis) and its non-clinical performance testing.
However, I can extract the information that is present in the document which aligns with your request for device performance and study details, interpreting "acceptance criteria" through the lens of device validation for mechanical performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO 7206-6 & ISO 7206-4) | Reported Device Performance (M/L Taper Hip Prosthesis) |
|---|---|
| Meets requirements for proximal fatigue testing | Meets performance requirements |
| Meets requirements for distal fatigue testing | Meets performance requirements |
| Meets endotoxin limits (USP39-NF34 Chapter 161) | Met the endotoxin limits |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices tested) for the proximal and distal fatigue testing or bacterial endotoxin testing.
The data provenance is non-clinical testing, performed by the manufacturer, Zimmer, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This is not applicable as the document describes non-clinical mechanical and biological testing for a hardware device, not an AI/software medical device requiring expert-established ground truth. The "ground truth" here is the physical performance of the device against established standards.
4. Adjudication Method for the Test Set
This is not applicable for mechanical and biological non-clinical testing. Performance is assessed against quantitative standards outlined in the ISO and USP guidelines.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic AI/software devices, not for a hip prosthesis.
6. If a Standalone Performance Study was done
Yes, standalone (non-clinical) performance testing was done on the device itself. This included:
- Proximal fatigue testing to ISO 7206-6
- Distal fatigue testing to ISO 7206-4
- Bacterial endotoxin testing to USP39-NF34 Chapter 161
7. The Type of Ground Truth Used
For the non-clinical performance testing, the "ground truth" was defined by:
- Engineering performance standards (ISO 7206-6, ISO 7206-4) for mechanical properties.
- Biological safety limits (USP39-NF34 Chapter 161) for endotoxin levels.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical hip prosthesis, not an AI/software algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for a physical device.
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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 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Rhonda MyerProject Manager, Regulatory AffairsTelephone: (574) 371-9659Fax: (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 jointmetal/ceramic/polymer semi-constrained cementedor nonporous uncemented prosthesis. |
| Predicate Device: | M/L Taper Hip Prosthesis, K032726 (clearedOctober 22, 2003) and K042337 (cleared November4, 2004) |
| Device Description: | The Zimmer M/L Taper Hip Prosthesis is amodular, titanium alloy femoral stem designed toreplace the proximal femur in total hip arthroplasty.It is flat, collarless and features a proximal-to-distaltaper 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.
N/A