ALIGN Radial Head System

K231188 · Skeletal Dynamics, Inc. · KWI · Sep 28, 2023 · Orthopedic

Device Facts

• Record ID: K231188
• Device Name: ALIGN Radial Head System
• Applicant: Skeletal Dynamics, Inc.
• Product Code: KWI · Orthopedic
• Decision Date: Sep 28, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3170
• Device Class: Class 2
• Attributes: Therapeutic

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: o 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.

Device Story

ALIGN Radial Head System is a modular radial head prosthesis; designed to orient radial head perpendicular to forearm rotation axis. System components include cobalt chrome modular heads, cobalt chrome locking screws, and titanium alloy stems and necks. Used by orthopedic surgeons in clinical settings for radial head arthroplasty. Device is implanted via press-fit technique to replace damaged or fractured radial head; restores joint function and reduces pain associated with degenerative or post-traumatic conditions. Output is a physical orthopedic implant; clinical decision-making relies on surgeon assessment of joint destruction or fracture severity. Benefits include restoration of radio-humeral and proximal radio-ulnar joint mechanics.

Clinical Evidence

Bench testing only. Mechanical performance was verified through static and fatigue compression testing to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Modular radial head prosthesis. Materials: Cobalt chrome (heads, locking screws) and titanium alloy (stems, necks). Design: Orient radial head perpendicular to forearm rotation axis. Fixation: Press-fit. Sterility: Not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring radial head replacement due to degenerative or post-traumatic disabilities (pain, crepitation, decreased motion, joint destruction, subluxation) resistant to conservative treatment, primary replacement after radial head fracture, symptomatic sequelae post-resection, or revision of failed radial head arthroplasty.

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

• Align Radial Head System (K172688)

Reference Devices

• Align Radial Head System (K092721)

Submission Summary (Full Text)

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September 28, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Skeletal Dynamics Inc Alexandra Rodriguez Rojas Regulatory Affairs Manager 7300 North Kendall Drive Miami, Florida 33156

Re: K231188

Trade/Device Name: ALIGN 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: August 31, 2023 Received: September 1, 2023

Dear Alexandra Rodriguez Rojas:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by Farzana Farzana Sharmin -S Sharmin -S 09:48:20-04:00 Date: 2023.09.28

Farzana Sharmin Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

Submission Number (if known)

K231188

Device Name

# ALIGN Radial Head System

### Indications for Use (Describe)

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:
- o 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 510(k) SUMMARY Skeletal Dynamic's ALIGN Radial Head System

#### Submitter

Skeletal Dynamics, Inc. 7300 N. Kendall Drive Suite 400 Miami, FL 33156 Phone: [phone] Facsimile: 305-596-7591 E-mail: [e-mail] Contact Person: Alexandra Rodriquez Roias Date Prepared: August 31, 2023

#### Name and Classification

Trade Name: Align Radial Head System Common Name: Elbow Hemi Prosthesis, Radial Head Classification Name: Elbow joint radial (hemi-elbow) polymer prosthesis Classification Number: 21 CFR §888.3170 Regulatory Class: Class II Product Code: KWI

Predicate Devices Align Radial Head System (K172688) Reference Devices Align Radial Head System (K092721)

#### Device Description

The subject Align Radial Head System and the predicate Align Radial Head System (K172688) are a radial head prosthesis and instrumentation platform that is designed to orient the radial head perpendicular to the axis of forearm rotation. It consists of cobalt chrome modular heads in different sizes with cobalt chrome locking screws, titanium alloy stems, necks, and specialized instrumentation.

#### Indications for 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:
- o 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.

The device has the same intended use and indications for use as the Company's predicate Align Radial Head System (K172688). Thus, the Align Radial Head System satisfies the first criterion for substantial equivalence.

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#### Summary of Technological Characteristics

The technological characteristics of the Align Radial Head System are substantially equivalent to the predicate device as demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and does not present any new issues of safety or effectiveness. Both, the subject and predicate Align Radial Head Systems are designed to orient the radial head perpendicular to the axis of forearm rotation. Both consist of cobalt chrome modular heads in different sizes with cobalt chrome locking screws, titanium alloy stems, necks, and specialized instrumentation. The only technological difference between the predicate and subject Align Radial Head System is the new radial head and stem sizes.

#### Performance Testing

Mechanical testing which established equivalency included static and fatigue compression testing. Based on the verification results, the subject device is as safe and effective as the legally marketed predicate Align Radial Head System (K172688).

#### Conclusions

The Skeletal Dynamic's Align Radial Head System is substantially equivalent to the predicate device identified in this premarket notification.