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

AI/ML Overview

The provided document is a 510(k) summary for the Align Radial Head Arthroplasty System. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria or conducting a comprehensive study to prove device performance against such criteria as one might see for a diagnostic AI device.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable for this type of medical device submission (an orthopedic implant). The submission relies on non-clinical testing (mechanical fatigue and static tests, and cadaver studies) and material biocompatibility.

Here's an analysis based on the available information:

Device: Align Radial Head Arthroplasty System

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not present specific quantitative acceptance criteria in the format typically seen for AI/diagnostic devices (e.g., target sensitivity/specificity). Instead, the "acceptance criteria" are implied by the demonstration of:

Feature/Test	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance (Fatigue & Static Tests)	Device meets performance requirements under various positions to ensure structural integrity and mechanical connections.	Tests were performed to "evaluate the performance of the device and its mechanical connections." (Specific quantitative results or thresholds are not provided in this summary).
Surgical Procedure Repeatability (Cadaver Studies)	The surgical procedure for implantation is repeatable and consistent.	Cadaver studies were performed to "confirm the repeatability of the surgical procedure." (Specific quantitative results or metrics for repeatability are not provided in this summary).
Biocompatibility	Materials are recognized as safe for orthopedic implantation.	Materials (Ti-6AL-4V ELI per ASTM F 136-00 and CoCrMo per ASTM F-1537) have a "long history of safe use in the orthopedic industry." Titanium Plasma Spray coating is "similar to that found on other currently marketed orthopedic implant devices."
Material Equivalence	Materials are the same as or equivalent to predicate devices.	Utilizes "the same materials" as predicate devices (Acumed Anatomic Radial Head System - K041858 and Biomet Explore Radial Head - K051385).
Intended Use Equivalence	Indications for use are the same as predicate devices.	Has "The same indications for use and intended use" as predicate devices.
Basic Shape Equivalence	Basic shape is comparable to predicate devices.	Has "The same basic shape" as predicate devices.
Operating Principles Equivalence	Operates on the same principles as predicate devices.	Uses "the same operating principals" as predicate devices.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of clinical trials or AI/diagnostic performance. The "tests" here refer to non-clinical mechanical and cadaveric studies.
Data Provenance: Not applicable. The studies are laboratory-based (mechanical tests) and cadaveric. No patient data (retrospective or prospective) from specific countries is mentioned or required for this type of submission.

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

Number of Experts: Not applicable. For mechanical tests, the "ground truth" is determined by engineering specifications and material standards. For cadaver studies, the assessment of surgical repeatability would be performed by experienced surgeons, but specific numbers and their qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This concept applies primarily to image-based diagnostic studies involving multiple human readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that assist human readers. The Align Radial Head Arthroplasty System is an implantable device, not a diagnostic tool.

6. Standalone Performance Study

Standalone Performance Study: No, a standalone performance study (algorithm only without human-in-the-loop performance) was not done. This concept is for AI algorithms. The "standalone performance" for this device would be its mechanical integrity and biocompatibility, as evaluated by the non-clinical tests described.

7. Type of Ground Truth Used

The "ground truth" for this device is established through:

Engineering specifications and validated testing methods for mechanical properties (fatigue, static loads).
Biocompatibility standards and historical safe use data for materials.
Surgical expertise for assessing the repeatability of the implantation procedure in cadaveric models.
Comparison to legally marketed predicate devices for substantial equivalence (e.g., indications for use, materials, basic shape).

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model, so there is no training set in the conventional sense.

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

How Ground Truth for Training Set was Established: Not applicable, as there is no training set.

Summary

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AUG 08 2010

ﺎ ﺍﻟﻤﺮﺍﺟﻊ

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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 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

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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.

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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.

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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

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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

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.