IMPLEX RADIAL HEAD REPLACEMENT SYSTEM

K984290 · Implex Corp. · KWI · Jun 1, 1999 · Orthopedic

Device Facts

• Record ID: K984290
• Device Name: IMPLEX RADIAL HEAD REPLACEMENT SYSTEM
• Applicant: Implex Corp.
• Product Code: KWI · Orthopedic
• Decision Date: Jun 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3170
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Implex Radial Head Replacement System is indicated for: • Cemented Use Only. • Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: -Joint destruction and/or subluxation. -Resistance to conservative treatment. • Primary replacement after fracture of the radial head. • Symptomatic sequelae after radial head resection. • Revision following failed radial head arthroplasty.

Device Story

Modular radial head prosthesis; metallic head component (Co-Cr-Mo alloy) and Hedrocel porous tantalum stem. Head diameters: 16, 21, 26 mm; stem sizes: 7, 9, 11 mm. Inter-operatively cemented using PMMA bone cement. Used by orthopedic surgeons in clinical settings for radial head arthroplasty. Replaces damaged radial head to restore joint function, reduce pain, and improve motion in patients with degenerative or post-traumatic conditions.

Clinical Evidence

Bench testing only. Performance testing of the cemented modular assembly demonstrated high mechanical integrity. No clinical data provided.

Technological Characteristics

Modular prosthesis; metallic head (Co-Cr-Mo alloy); stem (Hedrocel porous tantalum). Fixation: PMMA bone cement. Head diameters: 16, 21, 26 mm. Stem sizes: 7, 9, 11 mm. Mechanical assembly.

Indications for Use

Indicated for patients requiring radial head replacement due to degenerative or post-traumatic disabilities (pain, crepitation, decreased motion) at the radio-humeral/proximal radio-ulnar joint, including joint destruction, subluxation, resistance to conservative treatment, primary fracture, sequelae after resection, or revision of failed arthroplasty. For cemented use only.

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

• Wright Medical Technology Metallic Radial Heads
• Avanta Orthopedics Avanta RHTM

Submission Summary (Full Text)

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K984290

| JUN 1 1999 | 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS | |
|---------------------------------------|--------------------------------------------|-------------------------------------------------------|
| Implex Radial Head Replacement System | | |
| | Submitter Name: | Implex Corp. |
| | Submitter Address: | 80 Commerce Drive<br>Allendale, New Jersey 07401-1600 |
| | Contact Person: | John Schalago or Robert Poggie, Ph.D. |
| | Phone Number: | [phone] |
| | Fax Number: | [phone] |
| | Date Prepared: | April 19, 1999 |
| | Device Trade Name: | Radial Head Surface Replacement |
| | Device Common Name: | Elbow joint humeral (hemi-elbow) prosthesis |
| | Classification Number<br>and Name: | 21 CFR § 888.3170 |

Substantial Equivalence: The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

Device Description: The Implex Radial Head Replacement System is a modular prosthesis consisting of a metallic head and a Hedrocel porous tantalum stem. The metallic head component is offered in three diameter options of 16, 21, and 26 mm. each with 4 head extension lenaths. The articulating surface of the head component is offered in Co-Cr-Mo alloy. The stem component is offered in three cross sectional sizes of 7, 9, and 11 mm, with corresponding stem lengths of 23, 30, and 37 mm, respectively. All stem size options are compatible with all head size options. The Implex Radial Head Replacement System is a modular system, and the metallic head must be inter-operatively cemented to the Hedrocel stem using PMMA bone cement.

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| 510(k) Summary of Safety and Effectiveness, Continued | |
|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The Implex Radial Head Replacement System is indicated for:<br>• Cemented Use Only.<br>• Replacement of the radial head for degenerative or post-<br>traumatic disabilities presenting pain, crepitation, and<br>decreased motion at the radio-humeral and/or proximal<br>radio-ulnar joint with:<br>-Joint destruction and/or subluxation.<br>-Resistance to conservative treatment.<br>• Primary replacement after fracture of the radial head.<br>• Symptomatic sequelae after radial head resection.<br>• Revision following failed radial head arthroplasty. |
| Predicate Device<br>Information: | The Implex Radial Head Replacement System is<br>substantially equivalent to Wright Medical Technology,<br>Metallic Radial Heads, and the Avanta Orthopedics, Avanta<br>RHTM. |
| Device Technological<br>Characteristics and<br>Comparison to<br>Predicate Device: | A comparison of device characteristics (materials, design,<br>configuration, and indications for use) included in this 510(k)<br>Premarket Notification supports a substantial equivalence<br>determination. |
| Performance Data: | Performance testing of the cemented modular assembly was<br>performed, and the results indicate that the assembly<br>possesses a high degree of mechanical integrity.<br>Additionally, the Implex Radial Head is manufactured from<br>materials with known performance characteristics (MAF<br>#920) and properties which are typically used in total joint<br>arthroplasty. |
| Conclusion: | The Implex Radial Head Replacement System is<br>substantially equivalent to the identified predicate devices. |

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Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 11 1999

John A. Schalago, RAC Manager of Regulatory Affairs Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600

Re: K984290 Trade Name: Implex Radial Head Replacement System Regulatory Class: II Product Code: KWI Dated: April 20, 1999 Received: April 21, 1999

Dear Mr. Schalago:

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. ਜ 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.

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## Page 2 - John A. Schalago, RAC

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.

If you desire specific advice for your device on our labeling requlation (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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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510(k) Number (if known):

K984290

Device Name:

Implex Radial Head Replacement System

Indications For Use:

The Implex Radial Head Replacement System indications for use are as follows:

- . For Cemented Use Only.
: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

- Replacement of the radial head for degenerative or post-traumatic . disabilities presenting pain, crepitation, and decreased motion at the radiohumeral and/or proximal radio-ulnar joint with:
- a) Joint destruction and/or subluxation.
- b) Resistance to conservative treatment.
- . Primary replacement after fracture of the radial head.
- Symptomatic sequelae after radial head resection. .
- Revision following failed radial head arthroplasty. .

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Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR...

Over-The-Counter Use

(Optional Format 1-2-96)

Piazzale

(Division Sign-Off) Division of General Restorative Devices 12984290 510(k) Number .