(51 days)
No
The 510(k) summary describes a mechanical implant (humeral plate) for fracture fixation and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is described as providing temporary fixation for fractures, which is a supportive rather than a therapeutic function.
No
The device is described as a plate for temporary fixation of humerus fractures, indicating a therapeutic or supportive function rather than a diagnostic one.
No
The device description clearly indicates it is a physical plate intended for surgical implantation, not a software application.
No, 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: The description clearly states the Tornier humeral plate is a device intended for temporary fixation of proximal humerus fractures. This is a surgical implant used directly on the patient's bone, not for testing samples outside the body.
- Intended Use: The intended use also describes treating fractures and related conditions of the proximal humerus, which is a surgical intervention, not a diagnostic test.
The information provided describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The Tornier humeral plate is indicated for simple or complex fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.
Product codes
KTT
Device Description
The Unity Humeral plate is intended to provide a temporary fixation of proximal humerus fractures. It is pre-contoured to fit the anatomical profile of the proximal humerus. The plate combines orientable screws, locking screws and cortical screws to provide compression and angular stable locking.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal humerus
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)
Synthes LCP Proximal Humerus Plates, Long, K041860, Numelock II System (Lateral Proximal Humerus Plate), Howmedica Osteronics Corporation, K041709
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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APR 2 1 2006
Implants Chirurgicaux
Summary of Safety and Effectiveness information 510(k) Premarket Notification – Unity Humeral Plate
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
| 1) Device name | |
|---|---|
| Trade name: | Unity Humeral Plate |
| Common name: | Humeral Plate |
| Classification name: | Single/multiple component metallic bone fixation appliances and accessories |
| Classification number: | 888.3030 |
2) Submitter
Tornier Rue Doyen Gosse 38330 Saint Ismier - France
-
Company contact Tornier Mrs Mireille Lémery Regulatory affairs Manager 161, rue Lavoisier - Montbonnot 38334 Saint Ismier Cedex - France Tel: 00 33 4 76 61 38 98 Fax: 00 33 4 76 61 35 33 e-mail : mireille.lemery@tornier.fr
-
Classification Device class: Class II Classification panel: Orthopedic Product code: KTT
5) Equivalent / Predicate device
Synthes LCP Proximal Humerus Plates, Long, K041860 Numelock II System (Lateral Proximal Humerus Plate), Howmedica Osteronics Corporation, K041709
Image /page/0/Picture/11 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is bold and has a slightly geometric design. The hexagon provides a border around the "T", creating a distinct and recognizable emblem.
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
SIEGE SOCIAL : rue du Doyen Gosse - 38330 SAINT-ISMIFR - FRANCE
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Implants Chirurgicaux
6) Device description
The Unity Humeral plate is intended to provide a temporary fixation of proximal humerus fractures. It is pre-contoured to fit the anatomical profile of the proximal humerus. The plate combines orientable screws, locking screws and cortical screws to provide compression and angular stable locking.
7) Materials
The humeral plate is made of stainless steel (ISO 5832-1) or low nickel stainless steel (ASTM F2229). The optional wire is made of stainless steel (ISO 5832-1). The associated screws are made of low nickel stainless steel (ASTM F2229).
8) Indications
The Tornier humeral plate is indicated for simple or complex fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.
Image /page/1/Picture/7 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is bold and geometric, with a slightly three-dimensional appearance. The hexagon provides a border around the 'T', creating a distinct and recognizable emblem.
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
Page 2/ page 2
SIEGE SOCIAL : rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE
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Image /page/2/Picture/1 description: The image shows a black and white emblem. The emblem features a symbol of three stylized human profiles facing right, with flowing lines suggesting movement or connection. These profiles are positioned to the right of a circular arrangement of text. The text is small and curves along the circle's perimeter, making it difficult to read without higher resolution. The emblem appears to represent a health or human services organization.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2006
Tornier c/o Mrs. Mircille Lémery Regulatory Affairs Manager 161, rue Lavoisier - Montbonnot 38334 Saint-Ismier Cedex - France
Re: K060545
Trade/Device Name: Unity Humeral Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: February 27, 2006 Received: March 8. 2006
Dear Mrs. Lémery:
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. FLA may publish further announcements concerning vour 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
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Page 2 -- Mrs. Mireille Lémery
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. 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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Hulur Lemir/us
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Unity Humeral Plate
Indications For Use:
The Tornier humeral plate is indicated for simple or complex fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.
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)
Heidi Lemons
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page I of 1
510(k) Number K010545