KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT

K030237 · Kapp Surgical Instrument, Inc. · KWI · Aug 29, 2003 · Orthopedic

Device Facts

• Record ID: K030237
• Device Name: KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT
• Applicant: Kapp Surgical Instrument, Inc.
• Product Code: KWI · Orthopedic
• Decision Date: Aug 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3170
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KAPP Radial Elbow Implant is intended to be used 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 radio-humeral and or proximal radio-ulnar joint with either joint destruction or subluxation visible on xray and or resistance to conservative treatment; Primary replacement after fracture of the radial head; Symptomatic sequelae after radial head resection; Revision following failed radial head arthroplasty. The device is intended for custom single use with bone cement.

Device Story

Custom radial head elbow implant; replaces proximal end of radius. Device consists of implant and sizers; fixed via intermedullary canal stem using bone cement. Used by orthopedic surgeons in clinical/surgical settings to treat degenerative or post-traumatic joint conditions, fractures, or failed prior arthroplasty. Provides mechanical replacement of radial head to restore joint function and reduce pain. Single-use device.

Clinical Evidence

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

Technological Characteristics

Material: 316L stainless steel. Fixation: Intermedullary canal stem. Constraint: Non-constrained. Configuration: Custom sizes (2, 2.5, 3, 4, 5, 6). Fixation method: Bone cement.

Indications for Use

Indicated for patients requiring proximal radial head replacement due to degenerative or post-traumatic disabilities (pain, crepitation, decreased motion, joint destruction, or subluxation), primary fracture, symptomatic sequelae post-resection, or revision of failed arthroplasty.

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

• Avanta Radial Head Implant
• Wright Medical Metallic Radial Head Implants

Submission Summary (Full Text)

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Kapp Surgical Instrument, Inc.

# AUG 2 9 2003

K030237 PG 142

## Attachment 1 - 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92, upon which the substantial equivalence determination is based.

#### Summary Information:

| Applicant: | Kapp Surgical Instrument Co., Inc.<br>4919 Warrensville Center Road<br>Warrensville Heights, Ohio 44128<br>Tel: [phone]<br>Fax: [phone] |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact : | Albert Santilli, President |
| Prepared: | January 22, 2003 |

## Device Identification:

| Proprietary Name: | Kapp Custom Radial Head Elbow Implant |
|----------------------------------------|--------------------------------------------------------------------------------|
| Common Name: | Radial Head Implant |
| Classification Name<br>and Regulation: | Prosthesis, Elbow, Hemi-radial, polymer,<br>21 CFR 888.3170, 87KWI |
| Predicate Device(s): | Avanta Radial Head Implant and<br>Wright Medical Metallic Radial Head Implants |

#### Device Description:

The Kapp Custom Radial Head Elbow Implant includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.

#### Indications for use:

The KAPP Custom Radial Elbow Implant is intended to be used for: replacement of the proximal end of the radius: Replacement of the radial head for degenerative, or posttraumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with either joint destruction or subluxation visible on x-ray and or resistance to conservative treatment; primary replacement after fracture of the radial head; symptomatic sequelae after radial head resection; revision following failed radial head arthroplasty. It is intended for custom single use with bone cement.

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Comparison to the Predicate Devices:

page 2 of 2

The legally marketed predicate devices to which this device is substantially equivalent is the Avanta Radial Head Implant and Wright Medical Technologies Metallic Radial Head Implants.

| Attribute | Candidate Device | Predicate Devices | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Kapp Custom Radial<br>Head Elbow Implant | Advanta Radial Head<br>Implant | WMT Metallic Radial<br>Head Implants |
| Use | Single Use | Single Use | Single Use |
| Fixation | Intermedullary Canal<br>Stem | Intermedullary Canal<br>Stem | Intermedullary Canal<br>Stem |
| Constraint | Non-constrained | Non-constrained | Non-constrained |
| Material | 316L Stainless Steel | Co-Cr/CpTi | Ti, Ti6Al4V, Co-Cr |
| Sizes | 6 custom sizes – 2, 2.5,<br>3, 4, 5, and 6 | 3 sizes: 1, 2, 3 | 7 sizes: 0, 1, 1.5, 2, 2.5,<br>3, 4 |
| Indications for use: | The KAPP Custom<br>Radial Elbow Implant is<br>intended to be used for:<br>replacement of the<br>proximal end of the<br>radius: Replacement of<br>the radial head for<br>degenerative, or post-<br>traumatic disabilities<br>presenting pain,<br>crepitation and<br>decreased motion at the<br>radio-humeral and or<br>proximal radio-ulnar<br>joint with either joint<br>destruction or<br>subluxation visible on<br>x-ray and or resistance<br>to conservative<br>treatment; primary<br>replacement after<br>fracture of the radial<br>head; symptomatic<br>sequelae after radial<br>head resection; revision<br>following failed radial<br>head arthroplasty. It is<br>intended for custom<br>single use with bone<br>cement. | The Advanta Radial<br>Head Implant is<br>intended for:<br>replacement of the<br>proximal end of the<br>radius: Replacement of<br>the radial head for<br>degenerative, or post-<br>traumatic disabilities<br>presenting pain,<br>crepitation and<br>decreased motion at the<br>radio-humeral and or<br>proximal radio-ulnar<br>joint with either joint<br>destruction or<br>subluxation visible on<br>x-ray and or resistance<br>to conservative<br>treatment; primary<br>replacement after<br>fracture of the radial<br>head; symptomatic<br>sequelae after radial<br>head resection; revision<br>following failed radial<br>head arthroplasty. | The WMT Metallic<br>Radial Head Implants<br>are intended for:<br>replacement of the<br>radial head for<br>degenerative, or post-<br>traumatic disabilities<br>presenting pain,<br>crepitation and<br>decreased motion at the<br>radio-humeral and or<br>proximal radio-ulnar<br>joint with: joint<br>destruction and or<br>subluxation visible on<br>x-ray and or resistance<br>to conservative<br>treatment; primary<br>replacement after<br>fracture of the radial<br>head; symptomatic<br>sequelae after radial<br>head resection; revision<br>following failed radial<br>head arthroplasty. |

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing shapes.

Public Health Service

AUG 2 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Albert N. Santilli President KAPP Surgical Instrument Company, Inc. 4919 Warrensville Center Rd. Warrensville Heights, Ohio 44128

K030237 Re:

> Trade/Device Name: KAPP Custom Radial Head Elbow Implant Regulation Number: 21 CFR 888. 3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: II Product Code: KWI Dated: June 6, 2003 Received: June 11, 2003

Dear Mr. Santilli:

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 (QS) 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 - Mr. Albert N. Santilli

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 may be obtained 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 yours,

Mach n Millerson

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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## Attachment 3 - Statement of Indications for Use

510(k) Number:

Device Name: KAPP Surgical Instrument, Inc. Radial Head Elbow Implant

Intended Use / Indications for Use:

The KAPP Radial Elbow Implant is intended to be used 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 radio-humeral and or proximal radio-ulnar joint with either joint destruction or subluxation visible on xray and or resistance to conservative treatment;

Primary replace nent after fracture of the radial head;

Symptomatic sequelae after radial head resection;

Revision following failed radial head arthroplasty

The device is inlended for custom single use with bone cement

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

()

for Mark N. Millham

Division of General, Festorative and Neurological De

510(k) Number ***_***_ K03023t

Prescription Use
(per 21 CFR 801.109)

OR

Over the Counter Use
Optional Format 1-2-96

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