Internal Joint Stabilizer - Elbow

K223318 · Skeletal Dynamics, Inc. · OZI · May 10, 2023 · Orthopedic

Device Facts

• Record ID: K223318
• Device Name: Internal Joint Stabilizer - Elbow
• Applicant: Skeletal Dynamics, Inc.
• Product Code: OZI · Orthopedic
• Decision Date: May 10, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Internal Joint Stabilizer- Elbow is intended to provide temporary stabilization of the elbow joint after trauma or chronic elbow dislocation.

Device Story

Internal Joint Stabilizer - Elbow provides temporary stabilization of elbow joint post-trauma or chronic dislocation. Device consists of titanium base plate, distal/proximal connecting rods, adjustable locking joints, and locking screws. Modification allows base plate attachment to previously cleared Proximal Ulna Plates (K171590) via cobalt chrome screws, rather than direct ulna application. Proximal connecting rod secures to distal humerus via cobalt chrome axis pin. System implanted by surgeons in clinical setting; provides internal stabilization via mechanical construct. Benefits patient by maintaining joint stability during healing process. Provided non-sterile; requires facility-based sterilization.

Clinical Evidence

Bench testing only. Mechanical testing, including static and fatigue testing of the construct applied to the cleared Proximal Ulna Plate, demonstrated equivalence to the predicate device.

Technological Characteristics

Titanium base plate; cobalt chrome screws (#4-40, 5.5mm) and axis pins (30mm-70mm). Mechanical fixation system with adjustable locking joints. Non-sterile; user-facility sterilization required.

Indications for Use

Indicated for patients requiring temporary stabilization of the elbow joint following trauma or chronic elbow dislocation.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Internal Joint Stabilizer - Elbow (K153208)

Reference Devices

• Distal Elbow Plating System (K171590)

Submission Summary (Full Text)

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May 10, 2023

Skeletal Dynamics, Inc. Alexandra Rodriguez Rojas Regulatory Affairs Manager 7300 N Kendall Drive, Suite 400 Miami, Florida 33156

Re: K223318

Trade/Device Name: Internal Joint Stabilizer - Elbow Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: OZI, LXT, HRS Dated: April 20, 2023 Received: April 20, 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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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 Joseph P. Joseph P. Russell -S Russell -S Date: 2023.05.10 14:43:44 -04'00'

For: Farzana Sharmin, Ph.D. Acting 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

Enclosure

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# Indications for Use

Submission Number (if known)

K223318

Device Name

Internal Joint Stabilizer - Elbow

Indications for Use (Describe)

The Internal Joint Stabilizer- Elbow is intended to provide temporary stabilization of the elbow joint after trauma or chronic elbow dislocation.

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

< | Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 510(k) SUMMARY Skeletal Dvnamic's Internal Joint Stabilizer - Elbow

## Submitter

Skeletal Dynamics, Inc. 7300 N. Kendall Drive Suite 400 Miami, FL 33156 Phone: [phone] Facsimile: 305-596-7591 Contact Person: Alexandra Rodriquez Rojas Date Prepared: October 21, 2022

#### Name and Classification

Trade Name: Internal Joint Stabilizer - Elbow Classification Name: Single/multiple component metallic bone fixation appliances and accessories Common Name: Internal Hinged Elbow Fixator Classification Number: 21 CFR §888.3030 Regulatory Class: Class II Product Code: OZI, LXT, HRS

#### Predicate Devices

Internal Joint Stabilizer - Elbow (K153208)

## Reference Devices

Distal Elbow Plating System (K171590)

#### Device Description

The Skeletal Dynamic's Internal Joint Stabilizer Elbow System (K153208) consists of a titanium base plate, with a Distal Connecting Rod and Proximal Connecting Rod, held together by adjustable locking joints and locking screws which allow for multiple degrees of freedom. The system is being modified to include an Internal Joint Stabilizer - Elbow titanium base plate applied to the Company's cleared Proximal Ulna Plates of the Distal Elbow Plating System (K171590), instead of directly to the ulna as does the base plate of the cleared Internal Joint Stabilizer Elbow System.

The subject Internal Joint Stabilizer- Elbow is attached to the cleared Proximal Ulna Plates by means of two #4-40 cobalt chrome screws of 5.5mm in length and the Proximal Connecting Rod is secured to the distal humerus at the axis of rotation using the cleared cobalt chrome axis pin provided in multiple lengths from 30mm to 70mm in 5mm increments. The modified system provides internal stabilization to the elbow joint in the same manner, function, and technology as the Company's cleared Internal Joint Stabilizer Elbow. The system includes specialized instrumentation.

When attached to the cleared Skeletal Dynamics proximal ulna plate, the Internal Joint Stabilizer Elbow sits on the same anatomical location over the ulna and under the musculature and soft tissue, as does the cleared Internal Joint Stabilizer - Elbow.

The system is provided non-sterile and is sterilized in the user facility.

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## Indications for Use

The Internal Joint Stabilizer - Elbow is intended to provide temporary stabilization of the elbow joint after trauma or chronic elbow dislocation.

## Summary of Technological Characteristics

The substantial equivalence of the Internal Joint Stabilizer Elbow to the predicate devices is demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging and does not present any different questions of safety or effectiveness. The device has the same intended use and indications for use as the Company's Internal Joint Stabilizer – Elbow (K153208).

## Performance Testing

Engineering analysis and mechanical testing demonstrated that the Skeletal Dynamic's Internal Joint Stabilizer Elbow is equivalent to its predicate device currently marketed. Mechanical testing which established equivalency included static and fatigue testing of the construct applied to Skeletal Dynamic's cleared Proximal Ulna Plate. Based on the verification results, the subject device is as safe and effective as the legally marketed predicate device.

#### Conclusions

The Skeletal Dynamic's Internal Joint Stabilizer - Elbow is substantially equivalent to the Internal Joint Stabilizer Elbow predicate device identified in this premarket notification.