TORNIER CEMENT RESTRICTOR

K061824 · Tornier · LZN · Sep 14, 2006 · General, Plastic Surgery

Device Facts

Record IDK061824
Device NameTORNIER CEMENT RESTRICTOR
ApplicantTornier
Product CodeLZN · General, Plastic Surgery
Decision DateSep 14, 2006
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.3300
Device ClassClass 2
AttributesTherapeutic

Intended 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.

Device Story

Diaphyseal plug for orthopedic joint arthroplasty; occludes medullary cavity prior to acrylic cement introduction. Prevents distal cement migration; facilitates cement pressurization during implant insertion. Flexible mechanism adapts to varying medullary canal diameters. Used by surgeons in clinical/OR settings. Benefits include improved cement mantle integrity and implant fixation.

Clinical Evidence

No clinical data provided; device relies on bench testing and design equivalence to previously cleared predicates.

Technological Characteristics

Diaphyseal plug made of ultra-high molecular weight polyethylene (ISO 5834-2). Includes a radiographic marker made of stainless steel (ISO 5832-1). Features a flexible mechanism for canal diameter adaptation. Non-software, mechanical device.

Indications for Use

Indicated for patients undergoing joint arthroplasty requiring occlusion of the medullary cavity to facilitate acrylic cement pressurization.

Regulatory Classification

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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{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 1) Device name Trade name: Common name: Classification name: Tornier Cement Restrictor Cement Restrictor Surgical mesh SEP 1 4 2006 2) Submitter Tornier Rue Doven Gosse 38330 Saint Ismier - France 3) 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 4) Classification Device class: Class II Classification panel: Orthopedic Product code: LZN 5) 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. Page 1 of 1
Innolitics
510(k) Summary
Decision Summary
Classification Order
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