(78 days)
Not Found
No
The device description and intended use clearly define a mechanical plug for orthopedic surgery. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a plug that occludes the medullary cavity to prevent cement flow, which is an ancillary function during a surgical procedure and does not directly treat a disease or condition.
No
Explanation: The device description states its purpose is to occlude the medullary cavity and prevent cement flow during surgery, which is a therapeutic or assistive function, not a diagnostic one. It does not analyze or interpret patient data to determine a medical condition or predict an outcome.
No
The device description clearly states it is a "diaphyseal plug" and describes its physical function in occluding the medullary cavity, indicating it is a physical hardware device.
Based on the provided information, the Tornier Cement Restrictor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Tornier Cement Restrictor Function: The description clearly states that the Tornier Cement Restrictor is a physical plug used during a surgical procedure (joint arthroplasty) to manage the flow of cement within the bone. It does not analyze any biological specimens.
Therefore, the Tornier Cement Restrictor is a surgical implant/accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Tornier Cement restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during joint arthroplasty. The Tornier Cement restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation when the implant is introduced.
Product codes
LZN
Device Description
The Tornier Cement Restrictor is a diaphyseal plug for orthopedic use. It is designed to occlude the medullary cavity before the introduction of acrylic cement. The Tornier Cement Restrictor is used to prevent the cement progression in the diaphysis and therefore facilitate the cement pressurization during the introduction of the implant. Its flexible mechanism makes it adaptable to different diameters of medullary canal to be occluded.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
medullary cavity
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)
K973453, K001932, K830949, K001733
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the text "K061824 (pg 1 of 2) TORNIER Implants Chirurgicaux". The word "TORNIER" is in a large, bold font. The text "Implants Chirurgicaux" is in a smaller font below the word "TORNIER".
Summary of Safety and Effectiveness information 510(k) Premarket Notification - Tornier Cement restrictor
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
- Device name Trade name: Common name: Classification name:
Tornier Cement Restrictor Cement Restrictor Surgical mesh
SEP 1 4 2006
-
Submitter Tornier Rue Doven 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 : mircille.lemery atomier fr
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Classification Device class: Class II Classification panel: Orthopedic Product code: LZN
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Equivalent / Predicate device Tornier Cement Restrictor, TORNIER, K973453, K001932 Allo Pro Cement Obturator, ALLO PRO, GmbH, K830949 Allen Medullary Cement Plug, ZIMMER, Inc, K001733
6) Device description
The Tornier Cement Restrictor is a diaphyseal plug for orthopedic use. It is designed to occlude the medullary cavity before the introduction of acrylic cement. The Tornier Cement Restrictor is used to prevent the cement progression in the diaphysis and therefore facilitate the cement pressurization during the introduction of the implant. Its flexible mechanism makes it adaptable to different diameters of medullary canal to be occluded.
Image /page/0/Picture/13 description: The image shows a logo with a stylized tree inside a hexagon. The tree has a thick trunk and branches that extend outwards and upwards. Above the tree, there is some text that is difficult to read due to the image quality. The logo has a simple, geometric design.
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 1/ page 2
SIEGE SOCIAL : ruc du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE
1
Image /page/1/Picture/0 description: The image shows the text "KC061824 (pg 2 of 2)" at the top. Below that is the word "TORNIER" in large, bold letters. Underneath "TORNIER" is the text "Implants Chirugicaux".
The present device modification submission consists in the addition of a small diaphyseal plug and an extension of the indication for use.
7) Materials
The Tornier cement restrictor is made of ultra high molecular weight polyethylene according to ISO standard 5834-2. The radiographic marker is made of stainless steel according to ISO standard 5832-1
8) Indications
The Tornier Cement restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during joint arthroplasty. The Tornier Cement restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressursation when the implant is introduced.
Image /page/1/Picture/6 description: The image shows a logo inside of a hexagon. The logo appears to be a tree with a large trunk and branches. There is some text above the tree, but it is too blurry to read. 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
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
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tornier % Mrs. Mireille Lemery 161, rue Lavoisier - Montbonnot 38334 Saint Ismier Cedex -France
SEP 1 4 2006
Re: K061824
Trade/Device Name: Tornier Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: LZN Dated: June 13, 2006 Received: June 29, 2006
Dear Mrs. Lemery:
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.
3
Page 2 - Mrs. Mireille Lemery
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/industry/support/index.html.
incerely vours.
Barbara, Buckup
Mark N. Melkerson 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): ├Обу824
Device Name: Tornier Cement Restrictor
Indications For Use:
The Tornier Cement restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during joint arthroplasty. The Tornier Cement restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation when the implant is introduced.
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)
10 18 Jul
Barbara Buehrn
(Division Sign-(Division Sign of General, Restorative, Division
and Neurological Devices
510(k) Number.
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