RADIAL HEAD IMPLANT

K011819 · Avanta Orthopaedics, Inc. · KWI · Jun 19, 2001 · Orthopedic

Device Facts

• Record ID: K011819
• Device Name: RADIAL HEAD IMPLANT
• Applicant: Avanta Orthopaedics, Inc.
• Product Code: KWI · Orthopedic
• Decision Date: Jun 19, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3170
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Avanta Orthopaedics Radial Head implant is intended for replacement of the proximal end of the radius: 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: joint destruction or subluxation visible on x-ray . resistance to conservative treatment . Primary replacement after fracture of the radial head Symptomatic sequelae after radial head resection .

Device Story

Radial head implant designed for surgical replacement of proximal radius. Implant features stem for intramedullary canal fixation; non-constrained design. Used by orthopedic surgeons in clinical/surgical settings. Provides mechanical replacement of radial head to restore joint function, alleviate pain, and address post-traumatic or degenerative disabilities. Implanted via surgical procedure; intended for long-term use (>30 days).

Clinical Evidence

No clinical data provided; substantial equivalence based on design characteristics and material comparisons.

Technological Characteristics

Radial head implant; materials include Cobalt-Chromium (Co-Cr) and Commercially Pure Titanium (CpTi); non-constrained design; intramedullary stem fixation; single-use; available in 3 sizes.

Indications for Use

Indicated for patients requiring replacement of the proximal radius due to degenerative or post-traumatic disabilities (pain, crepitation, decreased motion at radiohumeral/proximal radio-ulnar joints) with radiographic joint destruction/subluxation and resistance to conservative treatment; primary replacement after radial head fracture; or symptomatic sequelae following radial head resection.

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 Titanium Radial Head Implant (originally by Wright Medical)

Submission Summary (Full Text)

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K011819

# JUN 1 9 2001

#### 510 (k) Summary

Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:

Prepared: June 7, 2001

Applicant: Avanta Orthopaedics, Inc. 9369 Carroll Park Drive, Suite A San Diego, CA 92121

Telephone: [phone] Fax: [phone] Contact: Louise M. Focht

Device Name: Device Trade Name: Device Classification: Reviewing Panel: Regulation Number Product Code: Original Predicate Device:

Radial Head Implant Radial head implant Class II Orthopedic 21 CFR 888.3170 87 KWI Swanson Titanium Radial Head Implant originally by Wright Medical which has been marketed since 1994. 2030506 9001389

Registration Number: Owner Operator Number:

Device Description:

The radial head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.

Indications for Use:

A vanta Orthopaedics Radial Head implant is intended for replacement of the proximal end of the radius:

- 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:
- . joint destruction or subluxation visible on x-ray
- . resistance to conservative treatment
- Primary replacement after fracture of the radial head
- Symptomatic sequelae after radial head resection .

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#### Comparison to the Original Predicate Device:

The legally marketed predicate device to which this device is substantially equivalent is the Wright Medical Swanson Titanium Radial Head Implant.

Regulatory Class: II Product Code: 87 KXE

| | | Table 2. Comparison of Wright Medical and Avanta radial head | | |
|--|--|--------------------------------------------------------------|--|--|
| | | | | |

| Item | Avanta Product | Wright Medical Technologies |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Radial Head Implant | Swanson Titanium Radial Head |
| | | Implant |
| Use | Single use | Single use |
| Fixation | stem in intramedulary canal | stem in intramedulary canal |
| Constraint | non constrained | non constrained |
| Material | Co-Cr/CpTi. | Titanium |
| Sizes | 3 sizes, 1, 2, 3 | 5 sizes 1, 1.5, 2, 2.5, 3 |
| Indications for use | Avanta Orthopaedics Radial Head<br>implant is intended for replacement of<br>the proximal end of the radius:<br>Replacement of the radial head for<br>degenerative, or post-traumatic<br>disabilities presenting pain, crepitation<br>and decreased motion at the radio-<br>humeral and/or proximal radio-ulnar<br>joint with :<br>• joint destruction or subluxation<br>visible on x-ray<br>• resistance to conservative<br>treatment<br>Primary replacement after fracture of<br>the radial head<br>Symptomatic sequelae after radial head<br>resection<br>Revision following failed radial head<br>arthroplasty | Swanson Titanium Radial Head<br>implant is intended for replacement of<br>the proximal end of the radius:<br>Replacement of the radial head for<br>degenerative, or post-traumatic<br>disabilities presenting pain, crepitation<br>and decreased motion at the radio-<br>humeral and/or proximal radio-ulnar<br>joint with :<br>• joint destruction or subluxation<br>visible on x-ray<br>• resistance to conservative<br>treatment<br>Primary replacement after fracture of<br>the radial head<br>Symptomatic sequelae after radial head<br>resection<br>Revision following failed radial head<br>arthroplasty |

Similarities of the Avanta Orthopaedics Radial Head Implant and the Wright Medical Technology, Inc. Radial Head Implant include: Both devices are intended for single use only; Both devices are intended for surgical implantation longer than 30 days; Both devices are placed into the intramedullary canal of the proximal end of the radius; Both devices are made of industry standard materials. No new materials are introduced in either product; Both devices are comparably sized; Both devices have the same indications for use.

Summary:

The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.

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Public Health Service

JUN 1 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Louise Focht Regulatory Affairs Department Avanta Orthopaedics, Inc. 9369 A Carroll Park Drive San Diego, California 92121

Re: K011819

Trade Name: Radial Head Implant Regulation Number: 888.3170 Regulatory Class: II Product Code: KWI Dated: June 7, 2001 Received: June 11, 2001

Dear Ms. Focht:

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 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). 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 requirements, 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 - Ms. Louise Focht

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 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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Bmtalceetnoth

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

Enclosure

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Page

## 510 (k) Number (If Known): Device Name: Radial Head

#### Indications for Use:

Avanta Orthopaedics Radial Head implant is intended for replacement of the proximal end of the radius:

- 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:
- joint destruction or subluxation visible on x-ray .
- resistance to conservative treatment .
- . Primary replacement after fracture of the radial head
- Symptomatic sequelae after radial head resection .

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of General, Restorative and Neurological Devices

Prescription Use _ (Per 21 CFR 801.109)

OR

510(k) Number Center Use K011819

(Optional Format 1-2-96)

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