(126 days)
No
The document describes a mechanical implant system for radial head arthroplasty and does not mention any AI or ML components or functionalities.
Yes.
The device is an implantable system intended to reduce or relieve pain and restore function and motion to the elbow, which aligns with the definition of a therapeutic device.
No
Explanation: The provided text describes a radial head arthroplasty system, which is an implantable device used for surgical treatment to replace the radial head in the elbow. Its intended use is to reduce pain and restore function, not to diagnose a condition.
No
The device description clearly states the system is comprised of physical implants (radial head and radial stem) made of metal alloys, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Axia Radial Head System is a surgical implant intended for radial head arthroplasty. It is a physical device implanted into the elbow joint to replace the radial head.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, the Axia Radial Head System falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
KWI
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following tests were performed in this submission:
-
- 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.
- Modular Connection Testing per ASTM F 2009.
Key Metrics
Not Found
Predicate Device(s)
Evolve® Radial Head System (K060731)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JAN - 7 2014
- 510(k) Summary
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 CFR |
| 888.3170. This falls under the Orthopedics panel/87 as a Class II | |
| 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 | |
| (Predicate) | ||
| Material | CoCrMo (ASTM F1537) | CoCrMo (ASTM F1537) |
| Sizes | 6 Sizes | 6 Sizes |
| Diameters | ||
| size range | 18mm - 28mm | 18mm - 28mm |
| Height size | ||
| range | 1 height per size | +2mm offset |
| +4mm offset | ||
| Connection to | ||
| 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 | |
| +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.
3
K132735
Performance Testing
The following tests were performed in this submission:
-
- 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.
- Modular Connection Testing per ASTM F 2009.
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 (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
6
- 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