(211 days)
No
The device description focuses on mechanical components and their function, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are based on mechanical testing, not algorithmic performance.
Yes
The device is intended to provide temporary stabilization of the elbow joint, which is a therapeutic function.
No
Explanation: The device is described as a "stabilizer" intended to provide "temporary stabilization of the elbow joint" after trauma or chronic dislocation. This describes its function as a therapeutic or supportive device, not one used for diagnosis.
No
The device description explicitly details physical components made of titanium and cobalt chrome, including plates, rods, screws, and pins, which are surgically implanted. This is a hardware-based medical device.
No, 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 Function: The description clearly states that this device is an implantable system intended to provide mechanical stabilization of the elbow joint within the body. It is a surgical implant, not a device that analyzes biological samples.
- Intended Use: The intended use is to stabilize the elbow joint after trauma or dislocation, which is a structural and mechanical function, not a diagnostic one.
The device description, intended use, and lack of any mention of analyzing biological samples all indicate that this is a surgical implant and not an IVD.
N/A
Intended Use / Indications for Use
The Double Internal Joint Stabilizer - Elbow is intended to provide temporary stabilization of the elbow joint after trauma or chronic elbow dislocation.
Product codes
OZI, LXT
Device Description
The Predicate Internal Joint Stabilizer - Elbow (IJS-E) System consists of a titanium base plate, with the following components: 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 Proximal Connecting Rod is secured to the distal humerus at the axis of rotation using a cobalt chrome axis pin provided in multiple lengths from 30mm to 70mm in 5mm increments.
The subject Double Internal Joint Stabilizer - Elbow (IJS-E) System is modifying the predicate IJS-E Base Plate to add an additional set of components to the other side of the IJS-E Base plate. The Proximal Connecting Rods from each side of the Double IJS-E base plate are secured to the distal humerus at the axis of rotation using the predicate male axis pin from one side and the new female axis pin from the other side. The male axis pin telescopes within the female axis pin within the distal humerus.
The subject Double Internal Joint Stabilizer - Elbow Base Plate is attached to the Ulna by the same 3.5mm compression screws as the predicate IJS-E system (K153208). 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.
The system is provided non-sterile and is sterilized in the user facility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
elbow joint, distal humerus, Ulna
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Fatigue and stability testing demonstrated that the subject Double Internal Joint Stabilizer - Elbow is equivalent to its predicate device currently marketed. Based on the verification results, the subject device is as safe and effective as the legally marketed predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.
0
December 15, 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: K231447
Trade/Device Name: Double 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 Dated: November 10, 2023 Received: November 13, 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).
1
Your device is also subject to, among other requirements, the Quality System (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joseph P. Russell Digitally signed by Joseph P. Russell -S -2 Date: 2023.12.15 11:47:03 -05'00'
for: Farzana Sharmin, PhD 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
2
Indications for Use
Submission Number (if known)
Device Name
Double Internal Joint Stabilizer- Elbow
Indications for Use (Describe)
The Double 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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3
510(k) SUMMARY Skeletal Dynamic's Double Internal Joint Stabilizer - Elbow
Submitter
Skeletal Dvnamics. Inc. 7300 N. Kendall Drive Suite 400 Miami, FL 33156 Phone: 305-596-7585 Facsimile: 305-596-7591 Contact Person: Alexandra Rodriguez Rojas Date Prepared: May 17, 2023
Name and Classification
Trade Name: Double Internal Joint Stabilizer - Elbow Common Name: Internal Hinged Elbow Fixator Classification Name: Single/multiple component metallic bone fixation appliances and accessories Classification Number: 21 CFR §888.3030 Requlatory Class: Class II Product Code: OZI, LXT
Primary Predicate Device
Internal Joint Stabilizer - Elbow (K153208)
Reference Device
Internal Joint Stabilizer - Elbow (K223318)
Device Description
The Predicate Internal Joint Stabilizer - Elbow (IJS-E) System consists of a titanium base plate, with the following components: 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 Proximal Connecting Rod is secured to the distal humerus at the axis of rotation using a cobalt chrome axis pin provided in multiple lengths from 30mm to 70mm in 5mm increments.
The subject Double Internal Joint Stabilizer - Elbow (IJS-E) System is modifying the predicate IJS-E Base Plate to add an additional set of components to the other side of the IJS-E Base plate. The Proximal Connecting Rods from each side of the Double IJS-E base plate are secured to the distal humerus at the axis of rotation using the predicate male axis pin from one side and the new female axis pin from the other side. The male axis pin telescopes within the female axis pin within the distal humerus.
The subject Double Internal Joint Stabilizer - Elbow Base Plate is attached to the Ulna by the same 3.5mm compression screws as the predicate IJS-E system (K153208). 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.
The system is provided non-sterile and is sterilized in the user facility.
4
Indications for Use
The Double 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. While there are differences in the design, these differences do not present any different issues of safety or effectiveness.
Performance Testing
Fatigue and stability testing demonstrated that the subject Double Internal Joint Stabilizer - Elbow is equivalent to its predicate device currently marketed. 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.