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.

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).

AI/ML Overview

The provided text describes the Axia Radial Head System, a medical device, and its regulatory submission (K132735). It details the device's technical specifications, intended use, indications for use, and a single performance test conducted. However, the document does not contain information typically associated with acceptance criteria and a study to prove a device meets those criteria in the context of diagnostic or AI-driven medical devices.

The information provided pertains to the substantial equivalence of a physical orthopedic implant (radial head prosthesis) to a legally marketed predicate device, as part of a 510(k) submission to the FDA. The "acceptance criteria" here are defined by the FDA's regulatory requirements for substantial equivalence, primarily focusing on materials, design, and performance characteristics compared to a predicate.

Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable as they relate to studies for diagnostic devices or AI algorithms that predict or classify outcomes. This document describes a mechanical device for joint replacement.

Below is an attempt to structure the available information as requested, with explicit notes about what information is not present or not applicable given the nature of the device.

Acceptance Criteria and Device Performance Study (K132735 - Axia Radial Head System)

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, "acceptance criteria" are interpreted as demonstrating substantial equivalence to a predicate device (Evolve® Radial Head System - K060731) through shared technological characteristics and indications for use, and confirming the mechanical integrity of a critical component.

Acceptance Criteria (Demonstration of Substantial Equivalence and Mechanical Performance)	Reported Device Performance (Axia Radial Head System)
Pertaining to Substantial Equivalence:
1. Shared Indications for Use: The device must have indications for use that are substantially equivalent to the predicate device.	Meets Criteria: The Axia Radial Head System shares identical indications for use with the Evolve Radial Head System, including: Radial head replacement for degenerative or post-traumatic disabilities (pain, crepitation, decreased motion at radio-humeral/proximal radio-ulnar joint with joint destruction/subluxation or resistance to conservative treatment), primary radial head replacement after fracture, symptomatic sequelae after radial head resection, and revision following failed radial head arthroplasty. Both are intended for uncemented use only.
2. Shared Technological Characteristics (Head Implants): Materials, sizes, diameters, connection to stem, and surface finish of the radial heads must be substantially equivalent.	Meets Criteria: Both Axia and Evolve radial heads are made from CoCrMo (ASTM F1537), come in 6 sizes (18mm-28mm diameter range), use a taper connection to the stem, and have a polished articular surface. The only difference noted is that Evolve offers +2mm and +4mm offset heights, while Axia has "1 height per size" for the head, implying offsets are managed differently or at the stem level. The document concludes that "The technological features... are substantially equivalent."
3. Shared Technological Characteristics (Stem Implants): Materials, sizes, diameters, offset options, connection to head, surface finish, and fixation method of the stems must be substantially equivalent.	Meets Criteria: Both Axia and Evolve stems come in 6 sizes, have +0mm, +2mm, +4mm offset options, use a taper connection to the head, have a polished surface, and are designed for non-cemented fixation. The material differs (Axia: Ti6Al4V ASTM F136; Evolve: CoCrMo ASTM F1537) and diameter ranges are slightly different (Axia: 5mm-10mm; Evolve: 4.5mm-9.5mm). However, the document concludes that "The technological features... are substantially equivalent," implying these differences do not raise new questions of safety or effectiveness. The Axia system is also noted to have axially symmetric geometry, similar to the predicate implied by "shared technological characteristics."
Pertaining to Mechanical Performance:
4. Modular Connection Strength: The taper connection between the radial head and stem must demonstrate sufficient resistance to component disassembly, exceeding anticipated clinical requirements.	Meets Criteria: Modular Connection Testing per ASTM F2009 was performed. The worst-case taper connection strength was found to be equivalent to 9 times the peak in vivo force when assembled using the worst-case method. When using the recommended surgical technique, the connection strength was over 26 times the peak clinical load. These results indicate the taper design will provide sufficient connection strength.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: The document does not specify a "sample size" in the context of patient data or clinical cases. The performance testing was a mechanical bench test on device components.
- For the Modular Connection Testing (ASTM F 2009), the test used "worst case test components and worst case assembly conditions." The exact number of components tested for this mechanical evaluation is not provided.
Data Provenance: Not applicable in the context of patient data. The "data" comes from laboratory bench testing of physical device components.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable as this is a mechanical device performance test, not a diagnostic study requiring expert ground truth for interpretation of clinical data.

4. Adjudication Method for the Test Set

Not applicable. The "test set" was mechanical components undergoing physical stress testing, not clinical cases requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for diagnostic performance, typically for medical imaging devices or AI algorithms that assist human readers. The Axia Radial Head System is a physical orthopedic implant.

6. If a Standalone Study (i.e., algorithm-only performance) was done

No, a standalone study was not done. This is relevant for AI algorithms. The performance test conducted was for the mechanical integrity of the device components.

7. The Type of Ground Truth Used

The "ground truth" for the Modular Connection Testing was implicitly defined by the ASTM F2009 standard for determining axial disassembly force and comparison to "loads reported in the clinical literature for high demand patient activities." This is a measured mechanical property compared against established biomechanical data, not a clinical pathology, expert consensus, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. This device is not an AI algorithm, and therefore does not have a "training set."

Summary

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JAN - 7 2014

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 arynearson@imd.net Phone: (407) 770 0258 Fax: (407) 770 0231

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 CFR888.3170. This falls under the Orthopedics panel/87 as a Class IIdevice.
Device Product Code:	KWI
Predicate Devices:	Evolve® Radial Head System (K060731)

Device Description:

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).

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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(Predicate)
Material	CoCrMo (ASTM F1537)	CoCrMo (ASTM F1537)
Sizes	6 Sizes	6 Sizes
Diameterssize range	18mm - 28mm	18mm - 28mm
Height sizerange	1 height per size	+2mm offset+4mm offset
Connection tostem	Taper connection	Taper connection
Surface finish	Polished articular surface	Polished articular surface

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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+2mm+4mm	+0mm+2mm+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.

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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.

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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.

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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

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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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

Regulation Number and Section

§ 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.