TORNIER ELBOW PROSTHESIS

K050848 · Tornier · JDB · Jul 14, 2005 · Orthopedic

Device Facts

• Record ID: K050848
• Device Name: TORNIER ELBOW PROSTHESIS
• Applicant: Tornier
• Product Code: JDB · Orthopedic
• Decision Date: Jul 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3160
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Total elbow prosthesis; 3-part system (humeral, ulnar, radial components); modular humeral stem and spool; non-constrained design, becomes constrained when used with ulnar cup. Addition of ulnar bushing and individual humeral screw to previously cleared system. Used by surgeons for total elbow arthroplasty to restore joint function and reduce pain. Cemented fixation only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Modular 3-part system (humeral, ulnar, radial). Materials: CoCr alloy (ISO 5832-7, 5832-12, 5832-4), UHMWPE (ISO 5834-2), stainless steel (ISO 5832-9). Cemented fixation. Non-constrained design, convertible to constrained via ulnar cup.

Indications for Use

Indicated for patients requiring total elbow arthroplasty to relieve severe pain or disability due to primary/secondary osteoarthritis, rheumatoid arthritis, functional deformities, failed prior treatments, or unmanageable fractures. Intended for cemented use only.

Regulatory Classification

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).

Predicate Devices

• Coonrad / Morrey Total Elbow, Zimmer (K973357)
• Sorbie - Questor Elbow System, Wright (K955099)
• Tornier Elbow Prosthesis, Tornier (K000003, K011567 and K031218)

Submission Summary (Full Text)

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K050848 p1/2

# Implants Chirurgicar

## Summary of Safety and Effectiveness information 510(k) - TORNIER Elbow Prosthesis

JUL 1 4 2005

Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92

| 1) Device name | |
|----------------------|--------------------------------------------------------------------------|
| Trade name: | Latitude Elbow Prosthesis |
| Common name: | Total Elbow Prosthesis |
| Classification name: | Elbow joint metal/polymer semi-constrained cemented prosthesis |
| | Elbow joint metal/metal or metal/polymer constrained cemented prosthesis |

## 2) Submitter

Tornier S.A. B.P. 11 - Rue Doyen Gosse 38330 Saint Ismier - France

## 3) Company contact

Tornier S.A. Mrs Mireille Lémery Regulatory affairs & Quality Engineer ZIRST - 161, rue Lavoisier 38330 Montbonnot - France Tel: [phone] Fax: [phone] e-mail : [e-mail]

4) Classification Device class: Class II Classification panel: Orthopedic Product code: JDB and JDC \$ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis \$ 888.3150 Elbow joint metal/metal or metal/polymer constrained cemented prosthesis

## 5) Equivalent / Predicate device

Coonrad / Morrey Total Elbow, Zimmer (K973357) Sorbie - Questor Elbow System, Wright (K955099) Tornier Elbow Prosthesis, Tornier (K000003, K011567 and K031218)

## 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 elbow joint to its best working

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Image /page/0/Picture/16 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is composed of thick lines and has a slightly geometric design. The logo is black and white, with the "T" appearing to be solid black against a white background within the hexagon.

TORNIER S.A 161, rue Lavoisier 38330 MONTBONNOT FRANCE

Tél. : [phone] Fax : [phone]

S.A. au capital de l´800 000 F SIRET : 070 501 275 000 13 R.C.S. : B 070 501 275 CODE APE : 331 B

SIEGE SOCIAL : B.P. 11 - rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE

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KOTORYX p½

# Implants Chirurgicau

condition and to reduce or eliminate pain. The Tornier Elbow Prosthesis is intended to accomplish these goals. The Tornier Elbow prosthesis is intended for use as a cemented total elbow.

The Tornier Elbow Prosthesis is a 3-part system consisting of a humeral, a 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 cup the prosthesis becomes a constrained prosthesis.

The present device submission consists in the addition of two components to the previous cleared devices of the Tornier Elbow Prosthesis.

1st addition: ulnar bushing

2nd addition: individual humeral screw

The fundamental scientific technology (intended use, material, manufacturing methods, packaging and sterilization) of the Tornier elbow Prosthesis has not changed relative to the predicate device.

#### 7) Materials

Humeral implant components are available in CoCr alloy according to standard ISO 5832-7 or ISO 5832-12 or ISO 5832-4. The ulnar and radial components are made of CoCr alloy according to standard ISO 5832-7 or ISO 5832-12 or ISO 5832-4, and UHMWPE according to standard ISO 5834-2. The humeral screw is made of stainless steel according to ISO 5832-9.

#### 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 osteoarthitis 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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Image /page/1/Picture/15 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is bold and has a unique design, with the top part of the 'T' appearing to be split or layered. The hexagon provides a clear, geometric border around the central letter, making the logo distinct and recognizable. The logo is black and white.

TORNIER S.A 161, rue Lavoisier 38330 MONTBONNOT FRANCE

Tél. : [phone] Fax : [phone]

S.A. au capital de 1 800 000 F SIRET : 070 501 275 000 13 R.C.S. : B 070 501 275 CODE APE : 331 B

SIEGE SOCIAL : B.P. I 1 - rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles connected by flowing lines, representing the department's focus on people and their well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 2005

Ms. Mireille Lémery Regulatory Affairs & Quality Engineer Tornier S.A. ZIRST - 161, rue Lavoisier 38330 Montbonnot - France

Re: K050848

Trade/Device Name: Tornier Elbow Prosthesis Regulation Number: 21 CFR 888.3160, 21 CFR 888.3150 Regulation Name: Elbow joint metal/polymer semi-constrained cemented prosthesis, Elbow joint metal/metal or metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: JDB, JDC Dated: May 31, 2005 Received: June 02, 2005

Dear Ms. Mireille Lémery:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 tise sured in the encreases)76, the enactment date of the Medical Device Amendments, or to conniner of the first to may 20, 2017 - 11:11
devices that have been reclassified in accordance with the provisions of the Federal Food, DNI, de rices mat have been rockschire approval of a premarket approval application (PMA). and Cosmetic Too (110) that the device, subject to the general controls provisions of the Act. The 1 ou may, morelore, mains of the Act include requirements for annual registration, listing of general controls provisioning 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 If your device is olassined (corral controls. Existing major regulations affecting your device can may be subject to sach additions, 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 I least be devilsed that I Driver in that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must of any I coural statutes and reguirements, including, but not limited to: registration and listing (21 compy with an all allers (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Mireille Lémery

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manieting your and equivalence of your device to a legally prematics notification: "The PDF intembers on the sour 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 If you desire spocente at [phone]. Also, please note the regulation entitled, Colliact the Office of Compullier notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Stupt Clurda
Miriam Provost, Ph.D.

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

## 510(k) Number (if known): K050848

Device Name: Tornier Elbow Prosthesis

Indications For Use:

The Tornier Elbow Prosthesis is intended for total elbow The Former Drosthetic replacement with this device may be arthroplasty.
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 Device Evaluation (ODE)

Stot Murde
(Division Sign-Off)

Division of General. Restorative and Neurological Devices

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510(k) Number_KO50848