(37 days)
Avenir® Müller Stem is intended for:
Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.Acute traumatic fracture of the femoral head or neck.Avascular necrosis of the femoral head.
Avenir® Müller Stems are for cementless use only.
The Avenir® Cemented Hip Stem is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of:
Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseasesFailed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR)Acute traumatic fracture of the femoral head or neckAvascular necrosis of the femoral head.
The Avenir® Müller Stem is a titanium alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. It is a wedge-shaped, collarless design and features a three dimensional proximal-to-distal taper. The stem and neck are a single unit and the stem features proximal ribs on the anterior and posterior surfaces which are designed to increase stability. Except for the polished neck area, the surface of the stem is coated with Ti-6Al-4V titanium alloy plasma spray and oversprayed by a hydroxyapatite coating. The stem is available as both a lateralized and standard version.
The Avenir® Cemented Hip Stem is a stainless steel alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. It is a wedge-shaped, collarless design and features a three dimensional proximal-to-distal taper. The stem and neck are a single unit. The stem is highly polished and available as both a lateralized and standard version.
This document, K193030, is a 510(k) premarket notification for Zimmer GmbH's Avenir Müller Stem and Avenir Cemented Hip Stem. It's a submission for hip prostheses, and the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating AI performance as would be expected for a software-based device.
Based on the provided text, the device in question is a medical implant (hip stem), not an AI/software device. Therefore, the questions about "effect size of how much human readers improve with AI vs without AI assistance," "standalone (algorithm only without human-in-the-loop performance)," "training set," and "ground truth for the training set" are not applicable to this submission. The "acceptance criteria" here relate to the physical and mechanical properties of the implant and its packaging.
Here's an analysis of the provided information regarding the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (What was tested) | Reported Device Performance (Conclusion) |
|---|---|
| Packaging Configuration Change: | |
| - Maintenance of sterile barrier system integrity up to the point of use. | Packaging performance testing was performed to verify that packaging configuration maintains integrity of the sterile barrier system up to the point of use. |
| - Adequate protection of the product through hazards of sterilization, handling, distribution, and storage. | Packaging performance testing was performed to verify that packaging configuration provides adequate protection to the product through the hazards of sterilization, handling, distribution, and storage. |
| Correction of Instrument Classification from Class I to Class II (for certain system-specific Class II instruments): | |
| - Verification of mechanical integrity. | Amendment of Design Controls with verification of mechanical integrity was performed. |
| - Verification of resistance. | Amendment of Design Controls with verification of resistance was performed. |
| Overall Conclusion Regarding Substantial Equivalence: | The performance data and analyses demonstrate that: - any differences (modifications) do not raise new questions of safety and effectiveness as established with performance testing; and - the subject devices are at least as safe and effective as the legally marketed predicate device. The devices have the same intended use and similar indications for use, use the same operating principle, incorporate the same basic design and labeling, and are manufactured and sterilized using the same materials and processes as the predicate device. |
2. Sample sized used for the test set and the data provenance
- Sample Size:
- For Packaging Configuration testing: "Packaging Configuration testing was conducted by representative worst-case products." A specific number is not provided, but the approach indicates a focus on challenging scenarios to ensure robustness.
- For Instrument Classification (mechanical integrity and resistance): Not explicitly stated, but implies testing of the instruments.
- Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective, as these are non-clinical (laboratory/engineering) tests rather than human subject studies. Such tests are typically conducted in a controlled lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as this submission is for a physical medical device (hip stem) and its associated instruments and packaging, not an AI/software device that requires expert-established ground truth from medical images. The "ground truth" here is compliance with engineering standards and performance specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation (e.g., of medical images) where there might be disagreements among human readers. This submission describes non-clinical engineering and packaging tests.
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
This question is not applicable. This describes a physical medical device, not an AI-assisted diagnostic or treatment planning tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This describes a physical medical device, not a software algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's acceptance criteria is based on established engineering standards and regulatory requirements for the performance of medical device packaging (e.g., ISO 11607-1:2006 and ISO 11607-2:2006) and the mechanical integrity of instruments. These are objective, measurable criteria, not subjective expert consensus or clinical outcomes data.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of a 510(k) submission for a physical medical device. This term is relevant to AI/machine learning models.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image contains 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 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.
December 6, 2019
Zimmer GmbH Melanie Mitrov Regulatory Affairs, Specialist Sulzerallee 8 Winterthur, 8404 Switzerland
Re: K193030
Trade/Device Name: Avenir Muller Stem, Avenir Cemented Hip Stem 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, KWY, KWZ, LWJ, MEH, KWL Dated: October 24, 2019 Received: October 30, 2019
Dear Melanie Mitrov:
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 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
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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 (QS) 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.
Vesa Vuniqi, Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K193030
Device Name Avenir® Müller Stem
Indications for Use (Describe)
· Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.
· Failed previous hip surgery (not THA) where pain, deformity, or dysfunction persists.
· Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
· Acute traumatic fracture of the femoral head or neck.
· Avascular necrosis of the femoral head.
Avenir® Müller Stems are for cementless use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K193030
Device Name Avenir® Cemented Hip Stem
Indications for Use (Describe)
The product is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of:
- · Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseases
- · Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, or total hip replacement (THR)
- · Acute traumatic fracture of the femoral head or neck
- Avascular necrosis of the femoral head.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒Prescription Use (Part 21 CFR 801 Subpart D) | ☐Over-The-Counter Use (21 CFR 801 Subpart C) |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/4/Picture/0 description: The image shows the Zimmer Biomet logo. The logo consists of a blue circle with a white "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is in a dark gray color and is aligned to the right of the circle.
510(k) Summary
| Sponsor: | Zimmer GmbHSulzerallee 8, P.O. Box8404 Winterthur, Switzerland |
|---|---|
| Contact Person: | Melanie MitrovSpecialist, Regulatory AffairsTelephone: +41 58 854 233Fax: +41 58 854 233 |
| Date: | November 20, 2019 |
| Trade Name: | Avenir® Müller StemAvenir® Cemented Hip Stem |
| Common Name | Femoral Stem |
| Classification Product Code : | LZO, KWY, KWZ, LWJ, MEH, KWL |
| Device Classification Name: | prosthesis, hip, semi-constrained, metal/ceramic/polymer, cementedor non-porous, uncementedprosthesis, hip, hemi-, femoral, metal/polymer, cemented oruncementedprosthesis, hip, constrained, cemented or uncemented, metal/polymerprosthesis, hip, semi-constrained, metal/polymer, uncementedprosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphateprosthesis, hip, hemi-, femoral, metal |
| Regulation Number / Description: | 21 CFR § 888.3353 Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis.21 CFR § 888.3390 Hip joint femoral (hemi-hip) metal/polymercemented or uncemented prosthesis.21 CFR § 888.3310 Hip joint metal/polymer constrained cemented oruncemented prosthesis.21 CFR § 888.3360 Hip joint femoral (hemi-hip) metallic cemented oruncemented prosthesis.21 CFR § 888.3353 Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis.21 CFR § 888.3360 Hip joint femoral (hemi-hip) metallic cemented oruncemented prosthesis. |
| Primary Predicate Device: | Avenir® Müller Stem, manufactured by Zimmer GmbH, K123392,cleared March 2013 |
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Image /page/5/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a white "Z" inside, followed by the words "ZIMMER BIOMET" in a sans-serif font. The logo is simple and modern, and the blue and white color scheme is clean and professional.
| Reference Device: | Subject Device | Reference Device |
|---|---|---|
| Avenir® Cemented Hip Stem(K193030) only. | Avenir® Cemented Hip Stem,manufactured by ZimmerGmbH, K131884, clearedAugust 2013. | |
| Device Description: | The Avenir® Müller Stem is a titanium alloy femoral stem designed toreplace the proximal femur in total or hemi-hip arthroplasty. It is awedge-shaped, collarless design and features a three dimensionalproximal-to-distal taper. The stem and neck are a single unit and thestem features proximal ribs on the anterior and posterior surfaceswhich are designed to increase stability. Except for the polished neckarea, the surface of the stem is coated with Ti-6Al-4V titanium alloyplasma spray and oversprayed by a hydroxyapatite coating. The stemis available as both a lateralized and standard version.The Avenir® Cemented Hip Stem is a stainless steel alloy femoralstem designed to replace the proximal femur in total or hemi-hiparthroplasty. It is a wedge-shaped, collarless design and features athree dimensional proximal-to-distal taper. The stem and neck are asingle unit. The stem is highly polished and available as both alateralized and standard version. | |
| Intended Use | Avenir® Müller Stem is intended for:Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.Failed previous hip surgery (not THA) where pain, deformityor dysfunction persists.Optional use in revision: in some medical conditions (e.g.,early revision when healthy and good bone stock exists), thesurgeon may opt to use primary implants in a revisionprocedure.Acute traumatic fracture of the femoral head or neck.Avascular necrosis of the femoral head.Avenir® Müller Stems are for cementless use only. | The Avenir® Cemented Hip Stem is intended for total or hemi hiparthroplasty with cemented applications for rehabilitating hipsdamaged as a result of:Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseasesFailed previous hip surgery including joint reconstruction(osteotomy), arthrodesis, hemiarthroplasty or total hipreplacement (THR)Acute traumatic fracture of the femoral head or neckAvascular necrosis of the femoral head. |
| Comparison to Predicate Device: | The intended use of the modified devices, as described in its labelinghas not changed as a result of the modifications proposed in the |
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Image /page/6/Picture/0 description: The image shows the Zimmer Biomet logo. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a simple, sans-serif font. The text is in a dark gray color, providing a contrast against the white background.
| present submission. Zimmer GmbH proposes modification of the indications for use thereby limiting the indications within those of the previously cleared devices. Modification of the packaging configuration for the subject implant devices is proposed. The new packaging configuration and the methods to support the package integrity have been previously described in K182048 (Avenir Complete Hip System). The proposed changes do not alter the fundamental scientific technology shared by both the subject devices and predicate device. Zimmer GmbH is furthermore seeking clearance for certain system-specific Class II instruments these instruments that have previously considered Class I exempt and correction of classification to Class II is proposed within present submission. | |
|---|---|
| Performance Data (Nonclinical and/or Clinical): | Non-Clinical Performance and Conclusions:Packaging configuration change:Packaging performance testing was performed to verify that packaging configuration maintains integrity of the sterile barrier system up to the point of use and provides adequate protection to the product through the hazards of sterilization, handling, distribution and storage according to ISO 11607-1:2006 and ISO 11607-2:2006. Packaging Configuration testing was conducted by representative worst-case products.Correction of instrument classification from Class I to Class II:Amendment of Design Controls with verification of mechanical integrity and resistance.Clinical Performance and Conclusions:Clinical data and conclusions were not needed for this device. |
| Conclusion: | The subject devices have the same intended use and similar indications for use as the predicate device. The subject devices use the same operating principle, incorporate the same basic design and labelling and are manufactured and sterilized using the same materials and processes as the predicate device.Except for the modifications described in this submission the subject devices are identical to the predicate device, and the performance data and analyses demonstrate that:any differences do not raise new questions of safety and effectiveness as established with performance testing; and the subject devices are at least as safe and effective as the legally marketed predicate device |
- legally marketed predicate device.
§ 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.