(28 days)
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.
The femoral stem is for cementless use only.
The Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System is a modular, wedge-shaped stem that is coated with Ti-6A1-4V titanium alloy plasma spray.
The provided text describes a 510(k) premarket notification for a hip prosthesis, not an AI/ML powered device. As such, the typical acceptance criteria and study designs associated with AI/ML devices (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts) are not applicable or mentioned in this document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance as these are not relevant to this type of device submission based on the provided information.
However, I can extract the information that is relevant to the "acceptance criteria" and "study" for this particular device submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meeting performance requirements for hip prostheses | "Non-clinical testing demonstrated that the Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System met performance requirements..." |
| Safety and effectiveness comparable to predicate device | "...and is as safe and effective as its predicate." |
| Same intended use as predicate device | "The subject device also has the same intended use... as the predicate device." |
| Same fixation methods as predicate device | "The subject device also has... the same... fixation methods as the predicate device." |
| Packaged, manufactured, and sterilized using same materials/processes as predicate | "The Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System is packaged, manufactured, and sterilized using the same materials and processes as its predicate." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This submission relies on non-clinical testing of the device itself, not patient data in the context of an AI/ML test set.
- Data Provenance: Not applicable. The "data" refers to the results of non-clinical device testing, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth as typically defined for AI/ML algorithms is not relevant here. Device performance is assessed through engineering and biocompatibility testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the context of AI/ML. The "ground truth" for this device's performance is established by recognized engineering standards and biocompatibility requirements for hip prostheses.
8. The sample size for the training set
- Not applicable.
9. How the ground truth for the training set was established
- Not applicable.
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K081007 (P3
Image /page/0/Picture/2 description: The image shows the logo for Zimmer. The logo consists of a stylized letter Z inside of a circle. Below the circle is the word "zimmer" in a bold, sans-serif font.
2
Summary of Safety and Effectiveness
| Sponsor: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Benjamin C. Curson, CQEAssociate, Regulatory AffairsTelephone: (574) 372-4119Fax: (574) 372-4605 |
| Date: | May 2, 2008 |
| Trade Name: | Zimmer® M/L Taper Hip Prosthesis with Kinectiv™Technology System |
| Common Name: | Total Hip Prosthesis |
| Classification Nameand Reference: | KWA - Hip joint metal/metal semi-constrained withuncemented acetabular shell, 21 CFR § 888. 3330 |
| Predicate Device: | Zimmer® M/L Taper Hip Prosthesis with ModularNeck Technology, manufactured by Zimmer, Inc.,K063251, cleared January 24, 2007. |
| Device Description: | The Zimmer M/L Taper Hip Prosthesis withKinectiv Technology System is a modular, wedge-shaped stem that is coated with Ti-6A1-4V titaniumalloy plasma spray. |
:
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Intended Use:
Comparison to Predicate Device:
K081007
The modular neck options allow for soft tissue balancing and easier restoration of the hip joint center of rotation. The modularity feature will allow surgeons to independently equalize leg length and optimize offset while, at the same time, maximizing joint stability for a variety of patient anatomies.
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; sccondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
The femoral stem is for cementless use only.
The Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System is packaged, manufactured, and stcrilized using the same materials and processes as its predicate. The subject device also has the same intended use and fixation methods as the predicate device.
Non-Clinical Performance and Conclusions: Performance Data (Nonclinical and/or Clinical): Non-clinical testing demonstrated that the Zimmer M/L Taper Hip Prosthesis with Kinectiv
Technology System met performance requirements and is as safe and effective as its predicate.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer, Inc. % Mr. Benjamin C. Curson P.O. Box 708 Warsaw, Indiana 46581-0708 MAY - 6 2008
K081007 Re: Trade/Device Name: Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prothesis Regulatory Class: Class III Product Code: KWA, JDL, LWJ, LZO, MEH Dated: April 4, 2008 Received: April 8, 2008
Dear Mr. Curson:
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.
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Page 2 - Mr. Benjamin C. Curson, CQE
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K081007
Device Name:
Zimmer® M/L Taper Hip Prosthesis with Kinectiv™Technology System
Indications for Use:
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, 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.
The femoral stem is for cementless use only.
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)
Neil Rf. Qal - Es mkn
(Division Sign-Off)
Division of General, Restorative. and Neurological Devices
Page 1 of 1
510(k) Number_
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.