(155 days)
Not Found
No
The summary describes a mechanical elbow prosthesis and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The modifications described are material changes and assembly variations of physical components.
Yes
The device is an elbow prosthesis intended to relieve pain, correct functional deformities, and restore joint function, which are therapeutic goals.
No
Explanation: The device is a prosthetic implant for total elbow arthroplasty, intended for treatment and replacement, not for diagnosis.
No
The device description clearly states it is a 3-part system consisting of physical components (humeral, ulnar, and radial components) intended for surgical implantation. It is a physical prosthesis, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Tornier Elbow Prosthesis is a physical implant designed to replace a damaged elbow joint. It is surgically implanted into the body.
- Intended Use: The intended use is for total elbow arthroplasty to relieve pain and disability, correct deformities, and treat fractures. This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The description clearly indicates a surgically implanted medical device, not a diagnostic tool used on biological samples.
N/A
Intended Use / Indications for Use
The Tornier Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthtitis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.
The Tornier Elbow Prosthesis is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JDB, JDC
Device Description
Total Elbow replacement is used to treat a number of clinical conditions such as severe pain or significant disability in degenerative, rheumatic disease of the elbow joint. It is also used in revision procedures where other treatments or devices have failed and treatment of fractures that are unmanageable using other techniques. The usual goal of such surgery is to restore the cloow joint to its best working condition and to reduce or eliminate pain. The Latitude Tornier Elbow Prosthesis is intended to accomplish these goals. The Tornier Elbow prosthesis is intended for use as a cemented total elbow.
The Latitude Tornier Elbow Prosthesis is a 3-part system consisting of a humeral, an ulnar and a radial component. The humeral implant is modular and consists in the assembly of various sizes of humeral stem and humeral spool in order to better reproduce the functionality of the natural humerus.
The prosthesis is a non-constrained prosthesis and when it is used with the ulnar cap the prosthesis becomes a semi-constrained prosthesis.
The present device submission corresponds to a modification in the assembly of the humeral stem with the humeral spool. Included in the modification the material of the ring stop has changed from UHMWPE to PEEK-OPTIMA. The radial components and the ulnar components are not modified. The technological characteristics (design, materials, manufacturing, sterilization, sizing and indications) of the modified humeral spool and humeral screw components are similar or identical to the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Elbow joint
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K000003, K011567, K031218 and K050848
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the word "TORNIER" in all capital letters, followed by a logo. The logo is a hexagon with the letter "T" inside of it. The letter "T" is also surrounded by a smaller hexagon.
AUG 2 4 2007
Summary of Safety and Effectiveness information Special 510(k) Premarket Notification - Latitude Tornier Elbow Prosthesis
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
| 1) Device name | |
|---|---|
| Trade name: | Latitude Elbow Prosthesis |
| Common name: | Elbow Prosthesis |
| Classification name: | Elbow joint metal/polymer semi-constrained cemented prosthesis |
| Elbow joint metal/metal or metal/polymer constrained cemented | |
| prosthesis | |
| Classification number: | 888.3160 and 888.3150 |
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Submitter Tornier Rue Doyen Gosse 38330 Saint Ismier - France
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Company contact Tornier Mrs Mircille 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
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Classification Device class: Class II Classification panel: Orthopedic Product code: JDB and JDC
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Equivalent / Predicate device
Tornier Elbow Prosthesis, Tornier, K000003, K011567, K031218 and K050848
6) Device description
Total Elbow replacement is used to treat a number of clinical conditions such as severe pain or significant disability in degenerative, rheumatic disease of the elbow joint. It is also used in revision procedures where other treatments or devices have failed and treatment of fractures that are unmanageable using other techniques. The usual goal of such surgery is to restore the
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TORNIER
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 www.tornier.com SAS au capital de 268 000 €. SIRET 070 501 275 000 13. R.C.S. Grenoble 070 501 275. Code APE 331 B ège social : chemin Doyen Gosse. 38330 Saint-Ismier. France
1
Image /page/1/Picture/0 description: The image shows the word "TORNIER" in all capital letters, with a logo to the right of the word. The logo is a hexagon with the letter "T" inside of it. The letter "T" is stylized with a smaller "T" inside of it.
cloow joint to its best working condition and to reduce or eliminate pain. The Latitude Tornier Elbow Prosthesis is intended to accomplish these goals. The Tornier Elbow prosthesis is intended for use as a cemented total elbow.
The Latitude Tornier Elbow Prosthesis is a 3-part system consisting of a humeral, an ulnar and a radial component. The humeral implant is modular and consists in the assembly of various sizes of humeral stem and humeral spool in order to better reproduce the functionality of the natural humerus.
The prosthesis is a non-constrained prosthesis and when it is used with the ulnar cap the prosthesis becomes a semi-constrained prosthesis.
The present device submission corresponds to a modification in the assembly of the humeral stem with the humeral spool. Included in the modification the material of the ring stop has changed from UHMWPE to PEEK-OPTIMA. The radial components and the ulnar components are not modified. The technological characteristics (design, materials, manufacturing, sterilization, sizing and indications) of the modified humeral spool and humeral screw components are similar or identical to the predicate devices.
7) Materials
The humeral stem is available in CoCr alloy. The humeral spool is available in CoCr alloy and PEEK-OPTIMA polymer. The humeral screw is available in stainless steel. The radial components are made of CoCr alloy and UHMWPE. The ulnar components are made of CoCr alloy and UHMWPE.
8) Indications
The Tornier Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthtitis and theumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.
The Tornier Elbow Prosthesis is intended for cemented use only.
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TORNIER
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 www.tornier.com SAS au capital de 288 000 € SIRET 070 501 275 000 13. R.C.S. Grenoble 070 501 275. Code APE 331 B al : chemin Doyen Gosse. 38330 Saint-tsmier. France
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tornicr % Mrs. Mireille Lémery Regulatory Affairs Manager 161, rue Lavoisier - Montbonnot 38334 Saint Ismier Cedex - France
Re: K070787
Trade/Device Name: Latitude Elbow Prosthesis Regulation Number: 21 CFR 888.3160 Regulation Name: Elbow joint metal/polymer semi-constrained prosthesis Regulatory Class: II Product Code: JDB, JDC Dated: July 20, 2007 Received: July 25, 2007
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, 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.
AUG 2 4 2007
3
Page 2 - Mrs. Mireille Lémery
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 legally marketed predicate device results in a classification for your device and thus, perrorts your cevice 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 on ) } ped. "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 toll-free number (800) 638-2011 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/dsma/dsmamain html
Sincerely yours.
Barbave BuellD
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
K070787 510(k) Number (if knøwn):
Device Name: Latitude Tornier Elbow Prosthesis
Indications For Use:
The Tornier Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthtitis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.
The Tornier Elbow Prosthesis is 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 Deyice Evaluation (Division Sign-Off) Division of General. and Neurological Devices
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510(k) Number K070787