AXIA RADIAL HEAD SYSTEM

K132735 · Imds (Innovative MEdical Device Systems) - Leis ME · KWI · Jan 7, 2014 · Orthopedic

Device Facts

• Record ID: K132735
• Device Name: AXIA RADIAL HEAD SYSTEM
• Applicant: Imds (Innovative MEdical Device Systems) - Leis ME
• Product Code: KWI · Orthopedic
• Decision Date: Jan 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3170
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Axia Radial Head System is intended to reduce or relieve pain and restore function and motion to the elbow. Radial head replacement for degenerative or post-traumatic disabilities when presenting with 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 radial head replacement after fracture Symptomatic sequelae after radial head resection Revision following failed radial head arthroplasty. CAUTION: This device is intended for uncemented use only.

Device Story

Axia Radial Head System is a 2-part modular orthopedic prosthesis consisting of a radial head implant and a radial stem implant. Designed for radial head arthroplasty to restore elbow function and relieve pain. Implants are available in 6 sizes for heads and stems, with 3 offset options to match patient anatomy. Radial heads are CoCrMo alloy; stems are Ti6Al4V alloy. Components feature a taper connection for assembly. Used by orthopedic surgeons in clinical settings for patients with degenerative or post-traumatic elbow conditions. Device is intended for uncemented fixation. Surgeon selects appropriate size/offset combination to reproduce patient anatomy. Taper connection provides mechanical stability against in vivo forces.

Clinical Evidence

Bench testing only. Modular connection testing performed per ASTM F2009 to evaluate resistance to component disassembly. Testing compared worst-case taper connection strength against peak in vivo forces reported in clinical literature. Results demonstrated connection strength equivalent to 9 times peak in vivo force (worst-case assembly) and over 26 times peak clinical load (recommended surgical technique).

Technological Characteristics

Radial head: CoCrMo alloy (ASTM F1537). Radial stem: Ti6Al4V alloy (ASTM F136). Modular taper connection. 6 head sizes (18-28mm), 6 stem sizes (5-10mm diameter), 3 offset options (0, 2, 4mm). Polished articular and stem surfaces. Non-cemented fixation. Axially symmetric geometry.

Indications for Use

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

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

• Evolve® Radial Head System (K060731)

Submission Summary (Full Text)

{0}------------------------------------------------

JAN - 7 2014

4. 510(k) Summary

K132735

Image /page/0/Picture/3 description: The image shows the logo for "imds Innovative Medical Device Solutions". The logo is in black and white. The letters "imds" are in a large, bold font, and the words "Innovative Medical Device Solutions" are in a smaller font below the letters.

Applicant/Sponsor:

IMDS (Innovative Medical Device Solutions) Corporate Headquarters 13600 Heritage Parkway, Suite 170 Fort Worth, TX 76177

Contact Person:

Andrew Rynearson Regulatory Council IMDS (Innovative Medical Device Solutions) 2710 Discovery Dr, Ste 600 Orlando, FL 32826 [e-mail] Phone: [phone] Fax: [phone]

Date:

1/6/14

#### DEVICE INFORMATION

| Proposed Trade Name: | Axia Radial Head System |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Elbow Hemi-, Prosthesis |
| Classification Name: | Elbow joint radial (hemi-elbow) polymer prosthesis per 21 CFR<br>888.3170. This falls under the Orthopedics panel/87 as a Class II<br>device. |
| Device Product Code: | KWI |
| Predicate Devices: | Evolve® Radial Head System (K060731) |

### Device Description:

The Axia Radial Head System is a 2-part system comprised of a radial head implant and a radial stem implant. There are 6 sizes of radial heads and 6 sizes of stem implant is available in 3 offset sizes. The large combination of implant sizes and the amount size interchangeability in the system allows for better reproduction of individual patient anatomy.

The Axia Radial Head System radial head implants are made from cobalt-chromium-molybdenum (Co-Cr-Mo) alloy. The radial head stems are made from titanium alloy (Ti-6Al-4V).

{1}------------------------------------------------

# K132735

# Intended Use:

●

#### Radial head arthroplasty

#### Indications for Use:

The Axia Radial Head System is intended to reduce or relieve pain and restore function and motion to the elbow.

- Radial head replacement for degenerative or post-traumatic disabilities when presenting with . pain, crepitation, and decreased motion at the radio-humeral and or proximal radio-ulnar joint with:
- 0 Joint destruction and/or subluxation
- Resistance to conservative treatment O .
- Primary radial head replacement after fracture
- Symptomatic sequelae after radial head resection ◆
- Revision following failed radial head arthroplasty .

CAUTION: This device is intended for uncemented use only.

Summary of Technological Characteristics

# Table 1: Feature Comparison of Subject and Predicate Heads

| | Heads | |
|-------------------------|----------------------------|------------------------------------------|
| | Axia Heads (Subject) | Wright Evolve Radial Head<br>(Predicate) |
| Material | CoCrMo (ASTM F1537) | CoCrMo (ASTM F1537) |
| Sizes | 6 Sizes | 6 Sizes |
| Diameters<br>size range | 18mm - 28mm | 18mm - 28mm |
| Height size<br>range | 1 height per size | +2mm offset<br>+4mm offset |
| Connection to<br>stem | Taper connection | Taper connection |
| Surface finish | Polished articular surface | Polished articular surface |

{2}------------------------------------------------

# K132735

#### Table 2: Feature Comparison of Subject and Predicate Stems

| | Stems | |
|--------------------|----------------------|---------------------------------|
| | Axia Stems (Subject) | Wright Evolve Stems (Predicate) |
| Material | Ti6Al4V (ASTM F136) | CoCrMo (ASTM F1537) |
| Sizes | 6 Sizes | 6 Sizes |
| Diameter Options | 5mm - 10mm | 4.5mm - 9.5mm |
| Offset Options | +0mm<br>+2mm<br>+4mm | +0mm<br>+2mm<br>+4mm |
| Connection to head | Taper connection | Taper connection |
| Surface finish | Polished | Polished |
| Fixation | Non cemented | Non cemented |

The Axia and Evolve radial head systems share the following indications:

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

The Axia and Evolve radial head systems share the following technological characteristics:

- . Co28CrMo (ASTM 1537) head Implants
- . 6 sizes of head implants ranging from 18mm-28mm
- . Taper Connection to stem
- . Polished articular surfaces on head implant
- . 6 sizes of stem implants
- +0, +2, +4, offset options .
- . Polished stem surface
- . Non cemented use
- Axially symmetric geometry .

The technological features of the Axia Radial Head System are substantially equivalent to the predicate device.

{3}------------------------------------------------

# K132735

#### Performance Testing

The following tests were performed in this submission:

- 1. Modular Connection Testing per ASTM F 2009.
An evaluation of the taper connection was performed to determine the resistance to component disassembly. The testing was performed in accordance with ASTM F2009 (Standard Test Method for Determining Axial Disassembly Force of Taper Connections of Modular Prostheses) using worst case test components and worst case assembly conditions. The results were compared with loads reported in the clinical literature for high demand patient activities. This comparison showed that the worst case taper connection strength is equivalent to 9 times the peak in vivo force when assembled using the worst case assembly method. When using the assembly method in the recommended surgical technique the connection strength was equivalent to over 26 times the peak clinical load. These results indicate that the taper design will provide a connection strength which exceeds the anticipated clinical requirements for the intended of this device.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The text is centered in the image.

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 7. 2014

IMDS (Innovative Medical Device Systems) Mr. Andrew Rynearson Associate Regulatory Counsel 2710 Discovery Drive, Suite 600 Orlando. Florida 32826

Re: K132735

Trade/Device Name: Axia Radial Head System Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: Class II Product Code: KWI Dated: December 4, 2013 Received: December 5, 2013

Dear Mr. Rynearson:

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. Please note: CDRH does not evaluate information related to contract fiability warranties. We remind you, however; that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{5}------------------------------------------------

# Page 2 - Mr. Andrew Rynearson

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note

the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Lori A. Wiqqins

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

3. Indications for Use Statement

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Axia Radial Head System

Indication for Use:

- · Radial head replacement for degenerative or post-traumatic disabilities with pain, crepltation, and decreased motion at the radio-humeral and or proximal radio-ulnar joint with:
- o Joint destruction and/or subluxation
- o Resistance to conservative treatment
- Primary radial head replacement after fracture
- · Symptomatic sequelae after radial head resection
- · Revision following failed radial head arthroplasty

CAUTION: This device is intended for uncemented use only.

Prescription Use _ × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Elizabeth Frank -S

Division of Orthopedic Devices