Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system of plates and screws for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

Yes
The device is described as "plates and screws" intended for "fixation of ... fractures, fusions, osteotomies, non-unions, malunions and reconstructions" of various bones in the upper and lower extremities and clavicle. This directly addresses medical conditions and aims to restore function, meeting the definition of a therapeutic device.

Diagnostic

No

Explanation: The device, SIGNEX plates and screws, is intended for the fixation of bones in various parts of the body following fractures, fusions, osteotomies, non-unions, malunions, and reconstructions. This is a therapeutic or reconstructive function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is comprised of "plates and screws" made of titanium, which are physical hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the SIGNEX plates and screws are for the fixation of fractures, fusions, osteotomies, non-unions, malunions, and reconstructions in various parts of the skeletal system. This is a structural and mechanical function within the body.
Device Description: The device is described as plates and screws made of titanium alloys, designed for bone fixation.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.

IVD devices are used in vitro (outside the body) to analyze biological samples. The SIGNEX plates and screws are implanted in vivo (inside the body) to provide structural support and stability to bones.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SIGNEX plates and screws are indicated for the fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, tarsals, metatarsals, phalanges), and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

The SIGNEX Hand System is indicated for fixation of hand (metacarpals, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

The SIGNEX Wrist System is indicated for fixation of wrist (distal radius, ulna) fractures, fusions, osteotomies, nonunions, malunions and reconstructions.

The SIGNEX Forearm System is indicated for fixation of forearm (radius and ulna) fractures, fusions, osteotomies, nonunions, malunions and reconstructions.

The SIGNEX Elbow System is indicated for fixation of elbow (distal humerus, olecranon, proximal radius and ulna) fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

The SIGNEX Humerus System is indicated for fixation of humerus fractures, fusions, osteotomies, malumions and reconstructions.

The SIGNEX Foot System is indicated for fixation of foot (tarsal, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

The SIGNEX Fibula System is indicated for fixation of fibula fractures, fusions, osteotomies, malunions and reconstructions.

The SIGNEX Tibia System is indicated for fixation of tibia fractures, fusions, osteotomies, malunions and reconstructions.

The SIGNEX Femur System is indicated for fixation of femur fractures, fusions, osteotomies, malunions and reconstructions.

The SIGNEX Clavicle System is indicated for fixation of clavicle fractures, fusions, osteotomies, non-unions and reconstructions.

Product codes

HRS, HWC

Device Description

The SIGNEX plates and screws are intended for closure /or bone fixation of fractures, fusion, osteotomies, non-union, malunion and reconstruction of hand, wrist, forearm, elbow, humerus, foot, fibia, tibia, femur and clavicle.

This is comprised of plates and screws. The plates are made of Pure Titanium (ASTM F67), Ti-6Al-4V ELI Titanium alloy (ASTM F136), and Screws are made of Ti-6A1-4V ELI Titanium alloy (ASTM F136). The plates and screws are single-use only, non-sterile products. so, those must be sterile before use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, fibula, tarsals, metatarsals, phalanges), and clavicle fractures
Hand, Wrist, Forearm, Elbow, Humerus, Foot, Fibula, Tibia, Femur, Clavicle

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 performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The tests of SIGNEX included:
· Cytotoxicity (ISO 10993-5)
· Sensitization (ISO 10993-10)
· Irritation or Intracutaneous reactivity (ISO 10993-10)
· Systemic toxicity (ISO 10993-11)
· Genotoxicity (ISO 10993-3)
· Pyrogen testing (ISO 10993-6)
· Implantation testing (ISO 10993-11)

SIGNEX is considered tissue/bone contacting for a duration of longer than 30 days. SIGNEX's plate and screw materials conform to ASTM F67 and ASTM F136 respectively for chemical composition.

Mechanical testing

· Torsion test (ASTM F543)
· Axial pullout strength test (ASTM F543)
· Driving torque test (ASTM F543)
· 4-Point bending test (ASTM F382)

The results of mechanical testing and theoretical analysis demonstrate SIGNEX to be substantially equivalent to the identified predicate device. The acceptance criteria for the mechanical testing were all met, supporting the overall conclusion of substantial equivalence for SIGNEX.

Clinical Studies
No clinical data were necessary for the demonstration of substantial equivalence.

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

Not Found

Predicate Device(s)

K123241

Reference Device(s)

K141489, K092609

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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June 11, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal of the Department of Health & Human Services - USA, which features an abstract image of an eagle. On the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a blue square.

OSTEONIC Co., Ltd. Hye-Min Ahn Assistant Manager 1206Ho, 38 Digital-ro 29-gil Guro-gu, Seoul 08381 Korea, South

Re: K230546

Trade/Device Name: SIGNEX Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: June 11, 2024 Received: June 10, 2024

Dear Hye-Min Ahn:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tejen D. Soni -S

For

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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

510(k) Number (if known) K230546

Device Name SIGNEX

Indications for Use (Describe)