K Number
K092721
Device Name
ALIGN RADIAL HEAD SYSTEM
Date Cleared
2010-08-03

(333 days)

Product Code
Regulation Number
888.3170
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Align Radial Head System and accessories are designed specifically for: - 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: - Joint destruction and/or subluxation, - 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 system is intended for press-fit use.
Device Description
The Align Radial Head System is a radial head prosthesis and instrumentation platform that is designed to orient the radial head perpendicular to the axis of forearm rotation. The fluted plasma coated radial Stem may assist in biological fixation, and is press fit into the medullary canal of the radius. Combined with its unique instrumentation, the ALIGN Radial Head offers the flexibility to adjust the orientation during implantation and restore motion at the radial head, then locks to form a monoblock prosthesis after the optimal implant positioning has been achieved. The Align Radial Head System is comprised of: - Multiple sized CoCr Radial Heads with Locking Screw . - Multiple sized titanium allov Stems, titanium plasma spray coated . - Stainless Steel K-Wires for optimal prosthesis alignment (not to be implanted) - System specific instrumentation
More Information

Not Found

No
The document describes a mechanical radial head prosthesis and associated surgical instrumentation, with no mention of software, algorithms, or any technology related to AI or ML.

Yes
The device is a prosthesis designed to replace a damaged radial head, aiming to restore function and alleviate pain, which are therapeutic goals.

No
This device is a prosthesis designed for replacement of the radial head, not for diagnosing medical conditions. Its intended use is for treatment, specifically surgical implantation, to restore function and alleviate symptoms.

No

The device description clearly outlines physical components such as radial heads, stems, K-wires, and instrumentation, indicating it is a hardware-based medical device.

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 (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
  • Device Description and Intended Use: The Align Radial Head System is a prosthetic implant designed to replace the radial head in the human body. It is a surgical device used in vivo (within the living body) to restore function and alleviate symptoms.
  • 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 Align 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 Alian Radial Head System and accessories are designed specifically for:

  • 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 and/or subluxation,
    • o 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 system is intended for press-fit use.

Product codes (comma separated list FDA assigned to the subject device)

KWI

Device Description

The Align Radial Head System is a radial head prosthesis and instrumentation platform that is designed to orient the radial head perpendicular to the axis of forearm rotation. The fluted plasma coated radial Stem may assist in biological fixation, and is press fit into the medullary canal of the radius. Combined with its unique instrumentation, the ALIGN Radial Head offers the flexibility to adjust the orientation during implantation and restore motion at the radial head, then locks to form a monoblock prosthesis after the optimal implant positioning has been achieved.
The Align Radial Head System is comprised of:

  • Multiple sized CoCr Radial Heads with Locking Screw .
  • Multiple sized titanium allov Stems, titanium plasma spray coated .
  • Stainless Steel K-Wires for optimal prosthesis alignment (not to be implanted) t
  • System specific instrumentation t

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

radial head, radiohumeral and/or proximal radio-ulnar joint

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

The following tests were performed to demonstrate that the Align Radial Head System is safe and effective:

  • Fatigue and static tests were performed in various positions to evaluate the . performance of the device and its mechanical connections.
  • Cadaver studies were performed to confirm the repeatability of the surgical . procedure. Conclusion:

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Acumed Anatomic Radial Head System - K041858, Biomet Explore Radial Head - K051385

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

Image /page/0/Picture/0 description: The image contains a series of alphanumeric characters that appear to be handwritten. The characters are 'K092721', with some of the characters having a slightly distorted or stylized appearance. The writing is in black ink against a white background, and the overall impression is that of a label or code.

Image /page/0/Picture/1 description: The image contains a handwritten fraction. The numerator is the number 1, and the denominator is the letter 'h'. The fraction is written in a simple, slightly slanted style.

AUG 08 2010

ﺎ ﺍﻟﻤﺮﺍﺟﻊ

Image /page/0/Picture/3 description: The image shows the logo for "skeletal dynamics". The logo consists of a stylized graphic to the left of the text. The graphic is a square shape divided into four smaller squares, with the top left and bottom right squares filled in black, and the other two squares are white. To the right of the graphic are the words "skeletal" on the top line and "dynamics" on the bottom line. The text is in a simple, sans-serif font.

510(k) Summary of Safety and Effectiveness Align Radial Head Arthroplasty System

July 7, 2010

Submitter:

Skeletal Dynamics, LLC 8905 SW 87 Avenue Suite 102 Miami, FL 33176 Tel: (305) 596-7585 Contact: Ana M. Escagedo / Vice President Quality & Regulatory Affairs Email: aescagedo@skeletaldynamics.com

FDA Establishment Registration Number: Pending

Trade Name, Common Name, Classification:

Device Trade Name: Align Radial Head System Device Common or Usual Names: Elbow Hemi Prosthesis, Radial Head Classification: Class II, 21 CFR 888.3170, Product Code KWI

Predicate Device:

Acumed Anatomic Radial Head System - K041858 Biomet Explore Radial Head - K051385

Description of the Device:

The Align Radial Head System is a radial head prosthesis and instrumentation platform that is designed to orient the radial head perpendicular to the axis of forearm rotation. The fluted plasma coated radial Stem may assist in biological fixation, and is press fit into the medullary canal of the radius. Combined with its unique instrumentation, the ALIGN Radial Head offers the flexibility to adjust the orientation during implantation and restore motion at the radial head, then locks to form a monoblock prosthesis after the optimal implant positioning has been achieved.

The Align Radial Head System is comprised of:

  • Multiple sized CoCr Radial Heads with Locking Screw .
  • Multiple sized titanium allov Stems, titanium plasma spray coated .
  • Stainless Steel K-Wires for optimal prosthesis alignment (not to be implanted) t
  • System specific instrumentation t

B

1

K092721$\frac{2}{2}$

Intended Use:

The Alian Radial Head System and accessories are designed specifically for:

  • 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 and/or subluxation,
      • o 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 system is intended for press-fit use.

Technological Characteristics:

The Align Radial Head System has the following similarities to the Anatomic Radial Head System manufactured and distributed by Acumed pursuant to K041858 and by Biomet pursuant to K051383:

  • . The same indications for use and intended use
  • . The same basic shape
  • Utilize the same materials .
  • Use the same operating principals .

Biocompatibility:

The materials selected for the Align Radial Head System have a long history of safe use in the orthopedic industry. The materials are Ti-6AL-4V ELI per ASTM F 136-00 and CoCrMo per ASTM F-1537. The Titanium Plasma Spray coating on the stem is similar to that found on other currently marketed orthopedic implant devices.

Summary of Non-Clinical Testing:

The following tests were performed to demonstrate that the Align Radial Head System is safe and effective:

  • Fatigue and static tests were performed in various positions to evaluate the . performance of the device and its mechanical connections.
  • Cadaver studies were performed to confirm the repeatability of the surgical . procedure. Conclusion:

We believe the subject device is substantially equivalent to the predicate device and conclude that the subject device is as safe and effective as the predicate device.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

:

AIG 08 2019

Skeletal Dynamics, LLC. % Orchid Design % Mr. Joseph Azary 80 Shelton Technology Center Shelton, Connecticut 06484

Re: K092721

Trade/Device Name: Align Radial head System Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: II Product Code: KWI Dated: July 26, 2010 Received: July 28, 2010

Dear Mr. Azary:

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 liability 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 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.

3

Page 2 - Mr. Joseph Azary

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A. Williams

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

Enclosure

4

K092724

AUG 03 2010

Indications for Use

'AUG 09'.

510(k) Number (if known): K092721

Device Name: Align Radial Head System

The Align Radial Head System and accessories are designed specifically for:

  • Replacement of the radial head for degenerative or post-traumatic disabilities g presenting 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 replacement after fracture of the radial head.
  • Symptomatic sequelae after radial head resection. ●
  • Revision following failed radial head arthroplasty. .

The system is intended for press-fit use.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21: CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Onuta for mxm
(Division Sign)

(Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices

Page I of I

510(k) Number K092721