(257 days)
No
The summary describes a mechanical implant for ankle replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated as a total ankle replacement for patients with ankle joints damaged by severe arthritis, which aligns with the definition of a therapeutic device since it is used to treat a disease or condition.
No
This device is an implantable prosthesis used for total ankle replacement, not for diagnosing medical conditions. Its purpose is to repair or replace a damaged ankle joint.
No
The device description clearly states it consists of physical components: a metal tibial base, a polyethylene articulating insert, and a metal talar resurfacing component. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The Salto Talaris Anatomic Ankle is a prosthetic implant designed to replace a damaged ankle joint. It is surgically implanted into the patient's body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or providing diagnostic information based on laboratory tests.
Therefore, the Salto Talaris Anatomic Ankle falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Salto Talaris Anatomic Ankle 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.
Product codes
HSN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle joints
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Alvine Total Ankle Prosthesis (Agility), DePuy, K920802, K020541, Topez Total Ankle Replacement. Topez Orthopedics. Inc., K051023
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
FEB 1 7 2009
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Tornier % Ms. Séverine Bonneton 161, rue Lavoisier - Montbonnot 38334 Saint Ismier Cedex - France
Re: K060544 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: August 23, 2006 Received: August 25, 2006
Dear Ms. Bonneton:
This letter corrects our substantially equivalent letter of November 13, 2006.
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 (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 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
1
Page 2 - Ms. Séverine Bonneton
CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to continue 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Mullens
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K060544
Device Name: Salto Talaris Total Ankle Prosthesis
Indications For Use:
The Salto Talaris Anatomic Ankle 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-Division of General, R. Crative,
and Neurological Devices
1666544
3
TORNIER
Implants Chirurgicaux K060544
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
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/3/Picture/15 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is bold and appears to be made of two overlapping 'T' shapes, creating a layered effect. The hexagon has a thin outline and is slightly irregular, giving it a hand-drawn or textured appearance.
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 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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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 Anatomic Ankle is indicated as a total ankle replacement in primary or revision surgery for paients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
All components are intended for cemented use only.
Image /page/4/Picture/8 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is formed by two mirrored shapes that resemble the letter "P", creating a symmetrical design. The logo has a simple, geometric style and is presented in 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 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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