(151 days)
Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.
The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with:
- . Rheumatoid arthritis.
- Post-traumatic arthritis. .
- Degenerative arthritis. .
This device is intended for cemented use only.
The Zimmer Trabecular Metal Total Ankle is an implant and instrument system designed to preserve motion in arthritic ankle patients. It is a semiconstrained device intended for the replacement of the articulating surfaces of the ankle that have been affected by a disease state or injury.
The Zimmer Trabecular Metal Total Ankle is a bicondylar system. The articular surfaces of the implants are designed to mimic the truncated cone shape of the natural ankle joint, thereby reproducing normal ankle joint kinematics.
The talar component is machined from a wrought Cobalt Chrome Molybdenum (CoCrMo) Alloy (Zimaloy®) diffusion bonded to a Trabecular Metal™ surface via an interlayer of commercially pure Titanium.
The tibial component consists of a Tivanium® (Ti-6Al-4V) tibial baseplate diffusion bonded to a Trabecular Metal™ surface and a modular insert of Prolong® Highly Crosslinked Polyethylene (HXLPE).
The provided document describes the 510(k) premarket notification for the Zimmer® Trabecular Metal™ Total Ankle. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing rather than presenting a study where a device's performance is measured against acceptance criteria in a clinical setting.
Therefore, the following information cannot be extracted or is not applicable based on the provided text:
- A table of acceptance criteria and the reported device performance: The document lists types of non-clinical tests performed but does not provide specific acceptance criteria values or the quantitative results of these tests. It only states that the device "met performance requirements."
- Sample size used for the test set and the data provenance: No clinical test set data is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No clinical test set data is provided.
- Adjudication method: No clinical test set data is provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: The document explicitly states, "Clinical data and conclusions were not needed for this device."
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
- The type of ground truth used: No clinical test set data is provided.
- The sample size for the training set: Not applicable as there is no mention of a training set for an algorithm.
- How the ground truth for the training set was established: Not applicable as there is no mention of a training set for an algorithm.
Summary of Device Acceptance Criteria and Study (Based on Non-Clinical Performance):
The Zimmer® Trabecular Metal™ Total Ankle device achieved acceptance through demonstration of substantial equivalence to predicate devices (Alvine Total Ankle Prosthesis (Agility) and Salto Talaris Total Ankle Prosthesis) based on non-clinical performance testing. The study performed was a series of engineering and material tests, not a clinical trial.
1. Table of Acceptance Criteria and Reported Device Performance:
As mentioned, specific quantitative acceptance criteria and detailed performance results are not provided in this summary. The document generally states that the device "met performance requirements."
| Acceptance Criteria Category (General) | Reported Device Performance |
|---|---|
| Material & Design Safety/Efficacy | Met performance requirements |
| Per FDA Guidance Document (Orthopedic Implants with Modified Metallic Surfaces) | Met performance requirements |
| Per ASTM F2665 (Total Ankle Replacement Prosthesis Standard) | Met performance requirements |
| MRI Compatibility | Met performance requirements |
| Range of Motion | Met performance requirements |
| Fatigue Analysis | Met performance requirements |
| Wear Evaluation | Met performance requirements |
| Contact Area / Contact Stress Evaluation | Met performance requirements |
| Constraint Evaluation | Met performance requirements |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the non-clinical tests. These tests typically involve a relevant number of components or systems as per the specific ASTM or internal test protocols.
- Data Provenance: The tests were conducted internally or by contracted labs by Zimmer, Inc., a US-based company, as part of their 510(k) submission. The data is non-clinical/engineering.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. Ground truth, in the context of clinical studies, refers to a definitive diagnosis or outcome. For non-clinical engineering tests, the "ground truth" is defined by the test standards and methodologies themselves, executed by qualified engineers and technicians. No mention of external experts establishing a ground truth for these engineering tests is provided.
4. Adjudication method for the test set:
Not applicable for non-clinical engineering tests. Results are typically analyzed and deemed to meet or not meet specifications by the testing personnel and verified by quality/regulatory teams.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
No. The document explicitly states: "Clinical data and conclusions were not needed for this device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical prosthetic device.
7. The type of ground truth used:
Not applicable in the clinical sense. For the non-clinical tests, the "ground truth" was established by recognized industry standards (e.g., ASTM F2665) and FDA guidance documents for orthopedic implant testing. Meeting these standards confirms the device's physical and mechanical properties.
8. The sample size for the training set:
Not applicable. This is not an AI/algorithm device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/algorithm device that requires a training set.
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Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter 'Z' inside. Below the circle, the word 'zimmer' is written in a sans-serif font.
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
AUG 2 4 2012
510(k) Summary
Sponsor:
Contact Person:
Date:
Trade Name:
Product Code / Device:
Regulation Number / Description:
Predicate Device:
Device Description:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Rebecca Dill Specialist, Regulatory Affairs Telephone: (574) 372-4260 Fax: (574) 372-4605
August 21, 2012
Zimmer® Trabecular Metal™ Total Ankle
HSN - Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
21 CFR § 888.3110 - Ankle Joint metal/polymer semi-constrained cemented prosthesis
Alvine Total Ankle Prosthesis (Agility), manufactured by Depuy Orthopaedics, Inc., K920802, cleared December 17, 1992 and K020541, cleared May 20, 2002. Salto Talaris Total Ankle Prosthesis, manufactured by Tornier Inc., K060544, cleared November 13, 2006.
The Zimmer Trabecular Metal Total Ankle is an implant and instrument system designed to preserve motion in arthritic ankle patients. It is a semiconstrained device intended for the replacement of the articulating surfaces of the ankle that have been affected by a disease state or injury.
The Zimmer Trabecular Metal Total Ankle is a bicondylar system. The articular surfaces of the implants are designed to mimic the truncated cone
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ের প্রতি
shape of the natural ankle joint, thereby reproducing normal ankle joint kinematics.
The talar component is machined from a wrought Cobalt Chrome Molybdenum (CoCrMo) Alloy (Zimaloy®) diffusion bonded to a Trabecular Metal™ surface via an interlayer of commercially pure Titanium.
The tibial component consists of a Tivanium® (Ti-6Al-4V) tibial baseplate diffusion bonded to a Trabecular Metal™ surface and a modular insert of Prolong® Highly Crosslinked Polyethylene (HXLPE).
Intended Use:
Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.
The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with:
- . Rheumatoid arthritis.
- Post-traumatic arthritis. .
- Degenerative arthritis. .
This device is intended for cemented use only.
The substantial equivalence of the Zimmer Trabecular Metal Total Ankle to the Alvine Total Ankle Prosthesis (Agility) and the Salto Talaris Total Ankle Prosthesis is demonstrated by its similarity in indications for use, design, materials, sterilization method, classification name and materials used.
Non-Clinical Performance and Conclusions:
The following non-clinical testing was performed. 1. Testing per FDA's guidance document
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
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"Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Or Bone Cement".
-
Testing per ASTM F2665 "Standard Specification for Total Ankle Replacement Prosthesis".
-
MRI compatibility testing for tibial and talar components.
-
Range of Motion of the Zimmer Trabecular Metal Total Ankle.
-
Fatigue Analysis of the Cemented Zimmer Trabecular Metal Modular Total Ankle Replacement System.
-
Wear Evaluation of the Zimmer Trabecular Metal Modular Total Ankle Replacement System.
-
Zimmer Trabecular Metal Modular Total Ankle Replacement System Contact Area / Contact Stress Evaluation. ·
-
Zimmer Trabecular Metal Modular Total Ankle System Constraint Evaluation
Non-clinical testing demonstrated that this device met performance requirements and is as safe and effective as the predicate device.
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized eagle-like symbol composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG 2 4 2012
Zimmer, Inc. % Ms. Rebecca Dill P.O. Box 708 Warsaw, IN 46581
Re: K120906
Trade/Device Name: Zimmer Trabecular Metal Total Ankle Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HSN Dated: August 15, 2012 Received: August 16, 2012
Dear Ms. Dill:
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 Part 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 (OS) 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,
Mark A. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): |( | 20 906
Device Name:
Zimmer® Trabecular Metal™ Total Ankle
Indications for Use:
Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.
The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with:
- . Rheumatoid arthritis.
- Post-traumatic arthritis. .
- Degenerative arthritis. .
This device is intended for cemented 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)
Ar
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(Division Sign-Oft) Division of Surgical, Orthopedic, ano Restorantes Devices
510(k) Number K120906
12
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.