(247 days)
Total hip replacement for patients with: severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Hemi-hip replacement for patients with: 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 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 purpose of this submission is to update the Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology Instructions for Use to include MR Conditional labeling within the precaution section. The device package label will also be updated to include the MR Conditional symbol. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization. The subject devices are intended for use in hip arthroplasty.
The provided text describes a 510(k) premarket notification for the "Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling." This submission is to update the Instructions for Use to include MR Conditional labeling, and therefore, does not involve studies proving clinical performance of the hip prosthesis itself. Instead, the studies focus on the MR safety of the device.
Here's an analysis of the provided information concerning the acceptance criteria and study proving MR safety:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (MR Safety) | Reported Device Performance |
|---|---|
| RF-induced heating: Device should not heat excessively during MRI. (Referenced standard: ASTM F2182-11a) | The submission indicates that Zimmer performed non-clinical MRI studies for RF-induced heating, aligning with ASTM F2182-11a, to determine the implants are "MR Conditional." While specific quantitative results are not provided in this summary, the statement "Non-clinical tests... establish the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment" implies that the heating criteria were met under specified MR conditions for MR Conditional labeling. |
| Image Artifact: Device should not cause significant image distortion or artifacts in MRI. (Referenced standard: ASTM F2119-07) | Zimmer performed non-clinical MRI studies for image artifact, aligning with ASTM F2119-07, to determine the implants are "MR Conditional." The summary states the tests establish "conditional safety and compatibility," suggesting the image artifact criteria were met under specified MR conditions. |
| Magnetic Displacement: Device should not experience undue displacement due to magnetic forces in MRI. (Referenced standard: ASTM F2052-14) | Zimmer performed non-clinical MRI studies for magnetic displacement, aligning with ASTM F2052-14, to determine the implants are "MR Conditional." The summary indicates these tests contribute to establishing "conditional safety and compatibility," implying the magnetic displacement criteria were met. |
| Overall MR Safety Status: Device must be designated as "MR Conditional" in accordance with ASTM F2503-13. | The submission's explicit purpose is "to update the Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology Instructions for Use to include MR Conditional labeling within the precaution section." The summary concludes that "Non-clinical tests... establish the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment." This confirms the device met the criteria for MR Conditional labeling. |
2. Sample Size Used for the Test Set and Data Provenance
The text does not specify the sample size used for the non-clinical MR safety tests. The data provenance is not explicitly stated in terms of country of origin, but it is clear these were non-clinical (in-vitro/benchtop) tests, not studies on human subjects, so concepts like "retrospective or prospective" do not apply.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable. The "ground truth" for MR safety in this context is established by adherence to recognized ASTM standards (ASTM F2503-13, ASTM F2182-11a, ASTM F2119-07, ASTM F2052-14) for evaluating physical interactions of the device with an MR environment. This is a technical assessment rather than an expert clinical consensus.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for interpreting clinical data or images by multiple experts. For non-clinical bench testing, the results are objectively measured and evaluated against the established standard's criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission is for MR labeling, not for demonstrating the clinical effectiveness of the hip prosthesis itself or comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This submission is about the MR safety of a physical implant, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for these tests is defined by the acceptance criteria specified in the referenced ASTM standards for evaluating MR safety parameters (RF-induced heating, image artifact, magnetic displacement). These standards provide objective methodologies and pass/fail criteria.
8. The Sample Size for the Training Set
This information is not applicable. There is no AI algorithm being trained in this submission. The tests are physical evaluations of a medical device.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for an AI algorithm. The ground truth for the non-clinical tests is established by the methods and criteria outlined in the relevant ASTM standards for MR safety testing.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Zimmer, Inc Caleb Barylski Regulatory Affairs Specialist P.O. Box 708 Warsaw, Indiana 46581-0708 May 31, 2019
Re: K182678
Trade/Device Name: Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, LWJ, LZO, MEH Dated: April 25, 2019 Received: April 29, 2019
Dear Caleb Barylski:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CAPT Raquel Peat, PhD, MPH, USPHS FOR Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K182678
Device Name
Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling
Indications for Use (Describe)
· Total hip replacement for patients with:
severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
· Hemi-hip replacement for patients with:
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 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the subject Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708Establishment Registration Number: 1822565 |
|---|---|
| Contact Person: | Caleb BarylskiSpecialist, Regulatory AffairsTelephone: (574-371-0250)Caleb.Barylski@zimmerbiomet.com |
| Date: | 08-Nov-2018 |
| Subject Device: | Trade Name: Zimmer M/L Taper Hip Prosthesis withKinectiv Technology MR LabelingCommon Name: Hip ProsthesisClassification Name:LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (21 CFR 888.3358)LWJ - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented (21 CFR 888.3360)LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (21 CFR 888.3353)MEH - Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate (21 CFR 888.3353) |
| Predicate Device(s): | Zimmer, Inc. |
| K063251 Zimmer M/L Taper Hip Prosthesis With Modular Neck Technology | |
| K071856 Zimmer M/L Taper Hip Prosthesis With Kinectiv Technology System, Model(S) 7848 Series( Modular Necks), 7713 Series | |
| K081007 Zimmer M/L Taper Hip Prosthesis With Kinectiv Technology System |
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Summary of Technological Characteristics:
The purpose of this submission is to update the Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology Instructions for Use to include MR Conditional labeling within the precaution section. The device package label will also be updated to include the MR Conditional symbol. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization. The subject devices are intended for use in hip arthroplasty. Specific indications for use are below.
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Indications for Use:
Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology
-
Total hip replacement for patients with: .
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; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. -
. Hemi-hip replacement for patients with:
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. .
Summary of Performance Data
Non-Clinical Tests: .
Zimmer has performed non-clinical Magnetic Resonance Imaging (MRI) studies on implants which are determined to be MR Conditional in accordance to ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. MR Tests included the following:
- RF-induced heating (ASTM F2182-11a)
- Image Artifact (ASTM F2119-07) ●
- . Magnetic Displacement (ASTM 2052-14)
- Clinical Tests: ●
Clinical data was not provided for the subject devices.
- Marketing History and Clinical Publications . A summary of the marketing history and clinical publications related to the subject devices is included.
Substantial Equivalence Conclusion
Non-clinical tests provided in this Traditional 510(k) establish the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment. The subject devices are substantially equivalent to the legally marketed predicated devices.
§ 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.