(122 days)
Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemi-arthroplasty or total hip replacement (THR). 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® Müller stem is a titanium alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. Except for the polished neck area, the surface of the stem is coated with air plasma sprayed (APS)-Ti and oversprayed by a hydroxyapatite coating. It is a wedge-shaped, collarless design with a proximal-to-distal taper. The stem is available as both a lateralized and standard version.
The provided document is a 510(k) summary for the Zimmer Biomet Avenir® Müller Stem, a hip prosthesis. This document describes the device and its substantial equivalence to predicate devices, focusing on non-clinical performance data. It explicitly states that clinical data and conclusions were not needed for this device.
Therefore, I cannot provide information on acceptance criteria based on clinical studies, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment related to clinical outcomes, as the submission did not include such studies.
Here's what can be extracted from the document regarding non-clinical performance:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide specific numerical acceptance criteria or performance values for each test. Instead, it makes a general statement: "The results of non-clinical (lab) performance testing demonstrate the devices are safe and effective and substantially equivalent to the predicate devices."
The types of non-clinical performance tests conducted were:
| Acceptance Criteria Focus (Implied) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Strength/Durability | Demonstrates safety, effectiveness, and substantial equivalence to predicate devices. |
| Coating Integrity | Demonstrates safety, effectiveness, and substantial equivalence to predicate devices. |
| Biocompatibility (implied by materials) | Demonstrates safety, effectiveness, and substantial equivalence to predicate devices. |
| Functional range | Demonstrates safety, effectiveness, and substantial equivalence to predicate devices. |
Note: The actual numerical acceptance limits and test results are not detailed in this summary document.
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: Not specified for non-clinical tests. Non-clinical tests typically involve a specific number of samples (e.g., n=5 or n=10 per test) as per relevant ISO or ASTM standards, but this detail is not in the summary.
- Data Provenance: The tests were "non-clinical (lab) performance testing" and conducted "in-house" or by contract labs following established test protocols. The country of origin of the data is implicitly Switzerland (Zimmer, GmbH is in Winterthur, Switzerland), though specific test locations are not detailed. These were prospective tests performed on the device prototypes/samples.
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. Non-clinical performance tests for medical devices are evaluated against engineering specifications and industry standards, not typically against expert-established ground truth in the same way clinical data is. The "ground truth" would be the successful demonstration of meeting predetermined engineering specifications/standards.
4. Adjudication method for the test set:
Not applicable for non-clinical tests. Evaluation is based on objective measurements against pass/fail criteria defined in engineering specifications and test protocols.
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 device is a hip implant, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device (hip implant), not an algorithm.
7. The type of ground truth used:
For non-clinical tests, the "ground truth" is adherence to established engineering specifications, relevant ASTM/ISO standards, and performance comparable to predicate devices. It is based on objective physical measurements and material characterization, rather than clinical outcomes or expert consensus.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI algorithm requiring a training set. If "training set" refers to design iterations or material selection, those details are not provided in this summary.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" in the context of this device's submission. The design and manufacturing process would follow established quality systems and engineering principles, with validation against specifications.
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Image /page/0/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" inside of a circle, with the word "zimmer" written in lowercase letters below it. The letter "Z" and the word "zimmer" are both in a bold, sans-serif font.
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K123392 Page 1/3
| Summary of Safety and Effectiveness | MAR 4 2013 | ||
|---|---|---|---|
| Sponsor: | Zimmer, GmbHSulzer Allee 8WinterthurCH-8404Switzerland | ||
| Contact Person: | Karen O'LearySenior Specialist, Regulatory AffairsTelephone: (574) 371-8515Fax: (574) 372-4605 | ||
| Date: | 01 November 2012 | ||
| Trade Name: | Avenir ® Müller Stem | ||
| Product Code / Device: | LZO - Prosthesis, hip, semi-constrained,metal/ceramic/polymer, cemented or non-porous,uncemented | ||
| LWJ - Prosthesis, hip, semi-constrained,metal/polymer, uncemented | |||
| MEH - Prosthesis, hip, semi-constrained,uncemented, metal/polymer, non-porous, calcium-phosphate. | |||
| KWZ - prosthesis, hip, constrained, cemented oruncemented, metal/polymer | |||
| KWY - prosthesis, hip, hemi-, femoral,metal/polymer, cemented or uncemented | |||
| Regulation Number / Description: | 21 CFR § 888.3353 Hip jointmetal/ceramic/polymer semi-constrained cementedor nonporous uncemented prosthesis. | ||
| 21 CFR § 888.3360 Hip joint femoral (hemi-hip)metallic cemented or uncemented prosthesis |
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21 CFR & 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
21 CFR § 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
21 CFR § 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
Corail AMTTM Hip Prosthesis, manufactured by DePuy Orthopaedics Inc, K042992, cleared February 11, 2005
Zimmer® Porolock MIS Stem, manufactured by Zimmer Inc, K071723, cleared March 03, 2008
The Avenir® Müller stem is a titanium alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. Except for the polished neck area, the surface of the stem is coated with air plasma sprayed (APS)-Ti and oversprayed by a hydroxyapatite coating. It is a wedge-shaped, collarless design with a proximal-to-distal taper. The stem is available as both a lateralized and standard version.
- . Advanced wear of the joint due to degenerative. post-traumatic or rheumatic diseases.
- . Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR).
- . 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® Müller Stem is similar or identical in intended use, materials, sterility and performance characteristics to the predicate device(s).
Predicate Device:
Device Description:
Intended Use:
Comparison to Predicate Device:
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Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
The results of non-clinical (lab) performance testing demonstrate the devices are safe and effective and substantially equivalent to the predicate devices. Performance testing/analysis included: Proximal Stem Fatigue Test, Distal Stem Fatigue, Pull-off Strength Testing, Hydroxyapatite Coating Characterization Testing, Plasma Spray Coating Characterization Testing, Hydroxyapatite Coating Characterization Evaluation of Real Aged Avenir Stems, Burst Strength Testing and Range of Motion analysis.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with flowing lines, representing the department's mission related to health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
March 4, 2013
Zimmer, GmbH % Zimmer Incorporated Ms. Karen O'Leary Senior Specialist, Regulatory Affairs Sulzer Allee 8 Winterthur CH-8404 Switzerland
Re: K123392
Trade/Device Name: Avenir® Müller 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, LWJ, MEH, KWZ, KWY Dated: January 29, 2013 Received: February 1, 2013
Dear Ms. O'Leary:
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
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Page 2 - Ms. Karen O'Leary
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Image /page/4/Picture/7 description: The image shows the name "Erin I.D. Keith" in a stylized font. The name is written in black ink and is centered in the image. The letters are bold and have a unique design, making the name stand out. The image appears to be a logo or signature.
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): K123392
Device Name: ^
Avenir® Müller Stem
Indications for Use:
- Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. ●
- Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, . hemi-arthroplasty or total hip replacement (THR).
- Acute traumatic fracture of the femoral head or neck. .
- . Avascular necrosis of the femoral head.
Avenir Müller Stems are 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)
Anton E. Dmitřiev, PhD Division of Orthopedic Devices
§ 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.