MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS

K031218 · Tornier · JDB · May 16, 2003 · Orthopedic

Device Facts

• Record ID: K031218
• Device Name: MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS
• Applicant: Tornier
• Product Code: JDB · Orthopedic
• Decision Date: May 16, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tornier Total Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated in the following cases: to relieve severe pain or significant disability in degenerative, rheumatoid or traumatic disease of the elbow joint; correction of functional deformities; revision procedures where other treatments or device have failed; treatment of fractures that are unmanageable using other techniques. The Tornier Total Elbow Prosthesis is intended for cemented use only.

Device Story

Tornier Total Elbow Prosthesis is a cemented orthopedic implant system for total elbow arthroplasty. This modification adds a longer ulnar stem, introduces alternative CoCr alloy grades, and updates the ulnar cap locking mechanism. The device replaces damaged or diseased elbow joint components to reduce pain, correct deformities, and restore joint function. It is implanted by orthopedic surgeons in a clinical/surgical setting. The prosthesis consists of humeral, ulnar, and radial components. By replacing the natural joint surfaces with metal and polymer components, the device provides a stable, functional joint, enabling patients to regain mobility and alleviate chronic pain associated with degenerative or traumatic conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Humeral components: CoCr alloy (ISO 5832-12 or ISO 5832-4). Ulnar/radial components: CoCr alloy (ISO 5832-7, 5832-12, or 5832-4) and UHMWPE (ISO 5834-2). Semi-constrained/constrained cemented prosthesis. Designed for cemented fixation.

Indications for Use

Indicated for patients requiring total elbow arthroplasty due to severe pain or disability from degenerative, rheumatoid, or traumatic elbow joint disease; 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 Total Elbow Prosthesis, Tornier (K000003)
• Tornier Total Elbow Prosthesis, Tornier (K011567)

Submission Summary (Full Text)

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031218

## Implants Chirurgicaux

MAY 1 6 2003

### Summary of Safety and Effectiveness information Special 510(k) - Tornier Total Elbow Prosthesis

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

| 1) Device name | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name: | <i>Tornier Total Elbow Prosthesis</i> |
| Common name: | Total Elbow Prosthesis |
| Classification name: | Elbow joint metal/polymer semi-constrained cemented prosthesis<br>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 Total Elbow Prosthesis, Tornier (K000003 and K011567)

Image /page/0/Picture/11 description: The image shows a logo with two letters, "T" and "P", intertwined within a hexagon. The letter "T" is at the top, partially overlapping the letter "P" below it. The logo is black and white, with the letters and the outline of the hexagon in black against a white background.

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

Page 1/ page 2

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

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# Implants Chirurgicar

#### 6) Device description

Total Elbow replacement are used to treat a number of clinical conditions such are 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 condition and to reduce or eliminate pain. The Tornier Total Elbow Prosthesis is intended to accomplish these goals. The Tornier Elbow prosthesis is intended for use as a cemented total elbow.

The present Device Modification submission corresponds to :

- the addition of one ulnar longer stem with the same diameter to the previous range with the same indications for use already covered by the previous 510(k) clearance,
- the addition of the possibility to manufacture some components in an other grade of CoCr alloy, the manufacturing method is unchanged compared to the previous 510(k) clearance,
- the modification of the locking mechanism of the ulnar cap. -

#### 7) Materials

Humeral implant components are available in CoCr alloy according to standard 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.

#### 8) Indications

The Tornier Total Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated in the following cases: to relieve severe pain or significant disability in degenerative, rheumatoid or traumatic disease of the elbow joint; correction of functional deformities; revision procedures where other treatments or device have failed; treatment of fractures that are unmanageable using other techniques.

The Tornier Total Elbow Prosthesis is intended for cemented use only.

KO 3/2/18

Page 2/ page 2

Image /page/1/Picture/14 description: The image is a black and white logo. The logo consists of a hexagon shape with a stylized letter "T" inside. The letter "T" is bold and has a unique design, with the top part of the "T" extending beyond the hexagon's top edge.

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. 11 - rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

MAY 1 6 2003

Re: K031218

Trade/Device Name: Tornier Total Elbow Prosthesis Regulation Numbers: 21 CFR 888.3150; 21 CFR 888.3160 Regulation Names: Elbow joint metal/polymer constrained cemented prosthesis. Elbow joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Codes: JDC, JDB Dated: April 2, 2003 Received: April 17, 2003

Dear Ms. 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 (OS) regulation (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) 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

sincerely yours,

Mark McMillan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 00<br>S | C | |
|---------|---|--------------------|
| | | ALL CHRIS COLLEGIA |

510(k) Number (if known): K031218

Tornier Total Elbow Prosthesis Device name:

#### Indication for use:

The Tornier Total Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated in the following cases: to relieve severe pain or significant disability in degenerative, rheumatoid or traumatic disease of the elbow joint; correction of functional deformities; revision procedures where other treatments or device have failed; treatment of fractures that are unmanageable using other techniques.

The Tornier Total Elbow Prosthesis is intended for cemented use only.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-------------------------|
| (Division Sign-Off) | |
| Division of General, Restorative | |
| and Neurological Devices | |
| 510(k) Number | K031218 |
| Prescription use | OR Over-The-Counter Use |

(Per 21 CFR 801.109)

(Optional format 1-2-96)