TORNIER BIPOLAR RADIAL HEAD PROSTHESIS

K994041 · Tornier, Inc. · KWI · Aug 31, 2000 · Orthopedic

Device Facts

• Record ID: K994041
• Device Name: TORNIER BIPOLAR RADIAL HEAD PROSTHESIS
• Applicant: Tornier, Inc.
• Product Code: KWI · Orthopedic
• Decision Date: Aug 31, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3170
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Acute traumatic fracture of the proximal radius not suitable for internal fixation. Unstable elbow following radial head resection, including wrist pain following radial head resection after radio-cubital dislocation or impingement of the carpus.

Device Story

Bipolar radial head prosthesis for elbow replacement; replaces proximal radius. Device consists of stem, metal head, and UHMWPE press-fit insert. Bipolar design features two articulation surfaces; movement occurs at path of least resistance between ball, cup, and natural joint surfaces. Stems and metal heads are FeCrCo steel; UHMWPE insert is molded/machined. Implanted by orthopedic surgeons in OR using specialized instrumentation. Provides mechanical replacement for damaged radial head; restores joint function; reduces pain associated with instability or impingement. Supplied sterile via gamma radiation.

Clinical Evidence

Biomechanical and clinical data provided to establish equivalence to predicate devices. No specific study metrics (e.g., sensitivity, p-values) reported in the summary document.

Technological Characteristics

Materials: FeCrCo steel (ISO 5832-7) and UHMWPE (ISO 5834-2). Design: Bipolar, three-part modular system (stem, metal head, UHMWPE insert). Stems are micro-bead blasted; neck/ball are mirror finished. Sterilization: Gamma radiation (min 2.5 Mrad/25 kGy).

Indications for Use

Indicated for patients with acute traumatic proximal radial fractures unsuitable for internal fixation, or unstable elbows following radial head resection, including those experiencing wrist pain due to radio-cubital dislocation or carpal impingement.

Regulatory Classification

Identification

An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.

Predicate Devices

• Swanson Radial Head Implant (Wright Medical Technologies, Inc.)
• Swanson Titanium Radial Head Implant (Wright Medical Technologies, Inc.)

Submission Summary (Full Text)

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**AUG 31 2000**

Radial Head

K994041-1

Tomier® Radial Head August 14, 2000

rosthesis

## rination ection 510rk) == Notification.

Regulatory Authority: Safe Medical Devices Act of 1990. 21 CFR 807.92

- 1. Device Name:
Trade Name: Tornier® Bipolar Radial Head Prosthesis Common Name: Radial head prosthesis Classification Name: Unclassified

- 2. Establishment Name & Registration Number:

| Name: | Tornier S.A. |
|---------|--------------|
| Number: | 8020756 |

#### 3. Classification:

## & 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.

(a) Identification. An elbow joint metallpolymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow ioint. 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 mide 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.

## § 888.3170 Elbow Joint radial (hemi-elbow) polymer prosthesis.

(a) Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.

(b) Classification. Class II.

Device Class: Presumed Class II Classification Panel: Orthopaedic Product Code: 87KWI, 87JDB

#### 4. Special Controls:

As a Class II medical device, this device is subject to special controls as promulgated by the FDA.

#### 6. Labeling:

.

Federal (United States) Law restricts this device to sale by or on the order of a physician. Please refer to Appendix I for samples of device labeling. Obtain and read all product literature before using the device.

#### 6. Summary Basis for Equivalence:

Based on the use of biocompatable materials, intended uses, basic design, clinical performance, biomechanical testing and surgical technique, the Tornier® Bipolar Radial Head Prosthesis is substantially equivalent or superior to the above referenced legally marketed devices.

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### 7. Equivalent / Predicate Device(s):

Swanson Radial Head Implant, Wright Medical Technologies, Inc. Swanson Titanium Radial Head Implant, Wright Medical Technologies, Inc.

#### 8. Device Description:

The Tornier® Bipolar Radial Head Prosthesis developed by Tornier combines modern materials, proven design concepts, and established operative techniques to produce an evolutionary advance in radial head implant replacement of the elbow.

## Design:

The design of the Tornier Bipolar Radial Head Prosthesis is, as the name implies, bipolar in nature. Bipolar implants as typified by many hip and hemi-hip implants possess two separate articulation surfaces. Movement in a bipolar joint can occur between aither or both of the bipolar articulating surfaces. The remaining "side" of the natural bony joint may articulate with the head of the implant, the ball of the stem may articulate within the cup of the imment read or movement between the ball, cup and remaining natural joint surfaces may occur simplitaneously. Depending upon the type of movement and the loading conditions imposed, the aniculation movement of the affected joint takes place following the path of least resistance. The shuth the stems are micro-bead blasted to a fine mate finish with the neck and ball of the stimmirror finished. The ultra high molecular weight polyethylene head insert is not "finished" per se, but molded and machined to required tolerances and surface configuration,

## Materials:

The materials used to construct the device are known as fron-cobalt-chrome (FeCrCo) and Ultra High Molecular Weight Polyethylene (UHMWPE). The device is made up of three parts, the sten, the metal head and the polyethylene press-fit insert. The stems are mede from FeCCC steel meeting international standard ISO 5832-7 (Feb94). The metal head is made from FeCCO steel also meeting 180 5832-7 (Feb94). The UHMWPE head meets ISO 5834-2 (Nov 186).

Instrumentation. Specialized instruments are required to properly implant the Tornier Bipolar Radial Head Prosthesis,

#### 9. Applicant Name & Address:

Tornier S.A. B.P. 11 - rue Doyen Gosse 38330 - Saint Ismier - France 011.334.7661.3500 011.334.7661.3533 - fax

#### 10. Company Contact:

Irene Gosset B.P. 11 - rue Doyen Gosse 38330 - Saint Ismier - France 011.334.7661.3500 011.334.7661.3533 - fax

#### 11. Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200Gregory Lane Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax

New Radial.doc

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#### 12. Manufacturing Facility:

The Tornier® Bipolar Radial Head Prosthesis is manufactured by Tomier, S.A. The product is distributed by Tornier, Inc. in the United States. Tornier, S.A. is a registered medical device manufacturing facility located in France.

#### 13. Performance Data:

Biomechanical and clinical data establish the equivalence of the design when contrasted with the indicated comparison devices.

#### 14. Sterilization Information;

The implantable product is supplied sterite from the manufacturer. The technique used to achieve sterilization is known as gemma radiation sterilization dose of at least 2.5 Mirad is utilized. The device may not be secondarily cleaned or resterilized. Once the product packaging is opened or damaged, the product is no longer considered sterite. Packaging must be inspected on arrival for evidence of shipping damage.

Damaged packaging renders the product unsafe and it should not be used. All shipping damaged Subsequently damaged product packaging requires product should be returned promptly. product replacement. Product for use in the operating room must be opened, handled and placed into use following accepted operating room sterile technique. The Sterlity Assurance Level (SAL) of the implants is at least 100 based on the minimum 25 kGy radiation dose.

The surgical instruments required to properly use the device are supplied clean only and must be sterilized prior to each use. Remove all labels and packaging materials before sterilization. Wash the instruments thoroughly before sterilization. The recommended method is steam autoclave sterilization. The recommended sterilization cycle is based on AAMI guidelines. The cycle is saturated steam at 270° F for 30 minutes.

#### 15. Special Guidance Document Information:

This submission was prepared in accordance with the guidance document detailing the content of a Premarket notification for Orthopaedic devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 3 1 2000

Mr. David W. Schlerf Tornier, Inc. c/o Buckman Company, Inc. 200 Gregory Lane Suite C-100 Pleasant Hill, California 94523

Re: K994041

Trade Name: Tornier Biopolar Radial Head Prosthesis Regulatory Class: II Product Code: KWI and JDB Dated: February 23, 2000 Received: June 29, 2000

## Dear Mr. Schlerf:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Mr. David W. Schlerf

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

e R. Lochner

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

Enclosure

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Tornier® Radial Head November 21, 1999

1 Page 1 of

510(k) Number: K994041

Tornier® Bipolar Radial Head Prosthesis Device Name:

## Indications For Use:

- Acute traumatic fracture of the proximal radius not suitable for internal fixation. ●
- Unstable elbow following radial head resection, including wrist pain following radial . head resection after radio-cubital dislocation or impingement of the carpus.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Deme R. Lochner:
(Division Sign-Off)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K994041

2, ll Prescription Use (Per 21 CFR 801.109)

OR

No Over-The-Counter Use (Optional format 1-2-96)

NewRadial.doc