(64 days)
The Salto Talaris Total Ankle Prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. All components are intended for cemented use only.
The goal of total ankle replacement is to restore function and relieve pain. The Salto Talaris Total Ankle Prosthesis is intended to accomplish these goals. The Salto Talaris Total Ankle Prosthesis is a semi-constrained anatomical design, which reproduces the kinematics of the ankle joint. The Tornier Salto Talaris Total Ankle Prosthesis consists of two mating components: a metal tibial base in association with a conforming polyethylene articulating insert, and a metal talar resurfacing component.
This document is a 510(k) premarket notification for the Salto Talaris Total Ankle Prosthesis, not a study report. Therefore, it does not contain the detailed information required to describe acceptance criteria and a study proving the device meets them in the format requested.
Specifically, the document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a clinical study with performance metrics, sample sizes, expert involvement, or statistical analysis.
However, based on the provided text, here's what can be inferred or stated about the device's intended use and regulatory status:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table of acceptance criteria or reported device performance in terms of clinical outcomes or specific metrics (e.g., success rates, pain reduction scores, range of motion improvements). The regulatory approval process for this type of device (510(k)) is based on demonstrating substantial equivalence to existing, legally marketed predicate devices, not on meeting predefined clinical performance acceptance criteria from a new clinical study.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This document does not describe a clinical study with a test set of patients.
- Data Provenance: Not applicable. The document references predicate devices (K060544, K920802, K020541, K051023) as a basis for substantial equivalence, but it doesn't provide new clinical data from a prospective or retrospective study for the Salto Talaris Total Ankle Prosthesis to evaluate its performance against specific criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No new clinical test set is described, and therefore no ground truth established by experts for such a set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No new clinical test set is described.
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 a medical device (prosthesis), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (prosthesis), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the context of a new clinical study for this 510(k). The "ground truth" for the device's approvability is its substantial equivalence to predicate devices, which implies that the predicate devices have established safety and effectiveness.
8. The sample size for the training set:
Not applicable. No training set for an algorithm is discussed.
9. How the ground truth for the training set was established:
Not applicable. No training set for an algorithm is discussed.
Summary based on the provided text:
The document is a regulatory submission demonstrating the substantial equivalence of the Salto Talaris Total Ankle Prosthesis to previously marketed devices. The "acceptance criteria" in this context are primarily regulatory – demonstrating that the device has similar technological characteristics and indications for use as existing predicate devices and does not raise new questions of safety or effectiveness. The "study" that "proves" this is the comparative analysis against the predicate devices presented in the 510(k) submission (though the details of this comparison are not elaborated in the provided excerpts beyond listing the predicates).
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Implants Chirurgicaux
K090076 1/2
MAR 1 7 2009
Summary of Safety and Effectiveness information Special 510(k) Premarket Notification - Salto Talaris Total Ankle Prosthesis
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
| 1) Device name | |
|---|---|
| Trade name: | Salto Talaris Total Ankle Prosthesis |
| Common name: | Total Ankle Prosthesis |
| Classification name: | 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis |
2) Submitter Tornier Rue Doyen Gosse
38330 Saint Ismier - France
3) Company contact
Tornier Mrs Séverine Bonneton Regulatory affairs Specialist 161, rue Lavoisier - Montbonnot 38334 Saint Ismier Cedex - France Tel: 00 33 4 76 61 35 00 Fax: 00 33 4 76 61 35 59 e-mail : severine.bonneton(@tornier.fr
4) Classification
| Device class: | Class II |
|---|---|
| Classification panel: | Orthopedic |
| Product code: | 87 HSN |
5) Equivalent / Predicate device
Salto Talaris Total Ankle Prosthesis, Tornier, K060544 Alvine Total Ankle Prosthesis (Agility), DePuy, K920802, K020541 Topez Total Ankle Replacement, Topez Orthopedics, Inc., K051023
6) Device description
The goal of total ankle replacement is to restore function and relieve pain. The Salto Talaris Total Ankle Prosthesis is intended to accomplish these goals. The Salto Talaris Total Ankle Prosthesis is a semi-constrained anatomical design, which reproduces the kinematics of the ankle joint.
The Tornier Salto Talaris Total Ankle Prosthesis consists of two mating components: a metal tibial base in association with a conforming polyethylene articulating insert, and a metal talar resurfacing component.
Image /page/0/Picture/17 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is bold and has a unique design, with the top part of the "T" appearing to be split or layered. The hexagon provides a geometric border around the letter, giving the logo a modern and structured appearance. The logo is black and white.
Tornier S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX France
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 Page 1/ page 2
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Implants Chirurgicau
7) Materials
The tibial base and the talar components are manufactured from Cobalt-Chromium alloy according to ISO 5832-4. The polyethylene insert is manufactured from implant grade ultra-high molecular weight polyethylene (UHMWPE) according to ISO 5834-2.
The bone contacting surfaces are coated with titanium plasma spray according to ASTM F1580.
8) Indications
The Salto Talaris Total Ankle Prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
All components are intended for cemented use only.
Image /page/1/Picture/7 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is bold and black, with a unique design where the top part of the 'T' is connected to the sides of the hexagon. There is a small, curved line above the hexagon, possibly representing an arc or a design element. The logo appears to be simple and modern, with a focus on geometric shapes.
Tornier S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX France
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 Page 2/ page 2
2/2
S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in providing health and human services to the people of the United States.
MAR 1 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tornier % Ms. Séverine Bonneton 161, rue Lavoiseir - Montbonnot 38334 Saint Ismier Cedex France
Re: K090076
Trade/Device Name: Salto Talaris Total Ankle Prosthesis Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HSN Dated: February 18, 2009 Received: February 20, 2009
Dear Ms. Bonneton:
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 - Ms. Séverine Bonneton
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 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
sincerely yours,
Mark N. Melkerson
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 (if known): K090076
Device Name: Salto Talaris Total Ankle Prosthesis
Indications For Use:
The Salto Talaris Total Ankle Prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
All components are intended for cemented use only.
Prescription Use. X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| (Division Sign-Off) |
| Division of General, Restorative, |
| and Neurological Devices |
| 510(k) Number 14090076 |
§ 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.