SIGNEX

{0}------------------------------------------------ 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). {1}------------------------------------------------ 2 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230546 Device Name SIGNEX ## Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) Summary ### 1. Date Prepared June 10, 2024 ### Submitter 2. OSTEONIC Co., Ltd. 405Ho, 505-2Ho, 505-3Ho, 508Ho, 902Ho, 1004Ho, 1202Ho, 1206Ho, 38 Digital-ro 29-gil, Gurogu, Seoul, Korea Tel: +82-2-6902-8434 Fax: +82-2-6902-8401 Contact Person: Hye Min, Ahn #### 3. Device Trade Name: SIGNEX Common Name: Plate, Fixation, Bone / Screw, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030) Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) Regulatory Class: II Product: HRS, HWC ### 4. Predicate Device 510(k) Number: K123241 Device Name: Arthrex Fracture Plates Manufacturer: Arthrex Inc. # Reference Device 510(k) number: K141489 Device Name: LINOS MOH Hand Plating System Manufacturer: KLS Martin L.P. 510(k) number: K092609 Device Name: Synthes 3.5 mm and 4.5 mm Curved Narrow and Broad Locking Compression Plates (LCP) Manufacturer: SYNTHES (USA) #### 5. 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. {5}------------------------------------------------ #### Indications for Use 6. The SIGNEX plates and screws are indicated for the fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, fibula, tarsals, phalanges), and clavicle fractures, fusions, osteotomies, non-unions 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, non-unions, malunions and reconstructions. The SIGNEX Forearm System is indicated for fixation of forearm (radius and ulna) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Elbow System is indicated for fixation of elbow (distal humerus, olecranon, proximal radius and ulna) fractures, fusions, osteotomies, mon-unions and reconstructions. The SIGNEX Humerus System is indicated for fixation of humerus fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Foot System is indicated for fixation of foot (tarsal, metatarsal, phalangeal) fractures, fusions, osteotomies, mon-unions, and reconstructions. The SIGNEX Fibula System is indicated for fixation of fibula fractures, fusions, osteotomies, non-unions, 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, malunions and reconstructions. #### 7. Performance Data 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. {6}------------------------------------------------ # 8. Substantial Equivalence Comparison | Description | Subject Device | Predicate Device | Reference Device | Reference Device | Equivalence<br>Discussion | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------| | Manufacturer | OSTEONIC Co., Ltd. | Arthrex Inc. | KLS Martin L.P. | SYNTHES (USA) | - | | Product Name | SIGNEX | Arthrex Fracture Plate | LINOS MOH Hand Plating<br>System | Synthes 3.5 mm and 4.5 mm<br>Curved Narrow and Broad<br>Locking Compression Plates<br>(LCP) | - | | 510(k) No. | K230546 | K123241 | K141489 | K092609 | - | | Product<br>Code | HRS, HWC | HRS, HWC | HRS | HRS, HWC | Same | | Regulatory<br>Class | Class II | Class II | Class II | Class II | Same | | Indications<br>for Use | The SIGNEX plates and<br>screws are indicated for the<br>fixation of upper extremity<br>(humerus, olecranon, radius,<br>ulna, metacarpals, phalanges),<br>lower extremity (femur, tibia,<br>fibula, tarsals, metatarsals,<br>phalanges), and clavicle<br>fractures, fusions, osteotomies,<br>non-unions, malunions and<br>reconstructions.<br>See Section 6 of this 510(k)<br>Summary for the complete<br>indications for use (IFU)<br>statement. | The Arthrex Fracture Plates<br>are intended to be used for<br>internal bone fixation for bone<br>fractures, fusions, osteotomies<br>and non-unions in the ankle,<br>foot, hand, wrist, clavicle,<br>scapula, olecranon, humerus,<br>radius, ulna, tibia, calcaneous,<br>fibula. | The LINOS MOH Hand<br>Plating System is used for<br>stabilization and fixation of<br>fractures, revision<br>procedures, -joint fusion and<br>reconstruction of small bones<br>of the hand, wrist, fingers, feet,<br>ankles and toes. | The Synthes 3.5mm Curved<br>Narrow and Broad LCP Plates<br>are intended for fixation of<br>fractures, osteotomies and non-<br>unions of clavicle, scapula,<br>olecranon, humerus, radius,<br>pelvis, distal tibia and fibula,<br>particularly in osteopenic bone<br>for adult patients.<br>The Synthes 4.5mm Curved<br>Narrow and Broad LCP Plates<br>are intended for fixation of<br>various long bones, such as the<br>humerus, femur, and tibia.<br>They are also for use in<br>fixation of periprosthetic<br>fractures, osteopenic bone, and | Similar | | Description | Subject Device | Predicate Device | Reference Device | Reference Device | Equivalence<br>Discussion | | | | | | non-unions or malunions in<br>adult patients.<br>The 3.5mm and 4.5mm Curved<br>Narrow and Broad LCP Plates<br>are also indicated for fracture<br>fixation of diaphyseal and<br>metaphyseal areas of long<br>bones in pediatric patients. | | | Anatomical<br>Sites | Hand, Wrist, Forearm, Elbow,<br>Humerus, Foot, Fibula, Tibia,<br>Femur, Clavicle | Ankle, Foot, Hand, Wrist,<br>Clavicle, Scapula, Olecranon,<br>Humerus, Radius, Ulna, Tibia<br>Calcaneus, Fibula | Hand, Wrist, Fingers, Feet,<br>Ankles, Toes | Clavicle, Scapula, Olecranon,<br>Humerus, Radius, Pelvis,<br>Distal tibia, Fibula | Same | | Material | • Plate<br>Pure Titanium (ASTM F67),<br>Titanium alloy (ASTM F136)<br>• Screw<br>Titanium alloy (ASTM F136) | Titanium, Stainless steel | CP Titanium,<br>Ti-6Al-4V Titanium Alloy | Titanium, Stainless steel | Similar | | Surface<br>Treatment | • Plate: Anodizing<br>• Screw: Anodizing | • Plate: Anodizing<br>• Screw: Anodizing | • Plate: Anodizing<br>• Screw: Anodizing | • Plate: Anodizing<br>• Screw: Anodizing | Similar | | Structure | The plate is composed of<br>various anatomical shapes such<br>as straight, Y-, T-, square<br>shapes, and so on.<br>The screw is composed of<br>cannulated and non-cannulated<br>screws. | The plate is composed of<br>various anatomical shapes such<br>as straight, Y-, T-, square<br>shapes, and so on.<br>The screw is composed of<br>cannulated and non-cannulated<br>screws. | The plate is pre-curved to<br>follow the natural curves of the<br>hand and feet bones.<br>The screw is composed of<br>locking and non-locking<br>screws. | The plate is composed of<br>various anatomical shapes.<br>The screw is composed of<br>various length of locking<br>screws. | Similar | | Product<br>Size | • Plate<br>length (6.90 to 280.00 mm),<br>thickness (0.60 to 5.00 mm) | • Plate<br>length (50 to 244 mm)<br>• Screw | • Plate<br>thickness (0.6 to 3.0 mm)<br>• Screw | • Plate<br>length (28 to 479 mm)<br>• Screw | Similar | | Description | Subject Device | Predicate Device | Reference Device | Reference Device | Equivalence<br>Discussion | | | • Screw<br>length (5.00 to 140.00 mm),<br>diameter (1.30 to 5.00 mm) | diameter (2.5 to 6.7 mm) | length (2.0 to 32.0 mm),<br>diameter (1.0 to 2.7 mm) | length (10 to 95 mm), diameter<br>(3.5 to 5.0 mm) | Refer to<br>Discussion<br>below. | | Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Same | | Single Use/<br>Reuse | Single-use | Single-use | Single-use | Single-use | Same | | Shelf-life | N/A | N/A | N/A | N/A | - | {7}------------------------------------------------ {8}------------------------------------------------ ### Discussion Since there is the difference in size of plate and the predicate device, the reference devices were compared for supporting the difference of the subjective device. Screw length was not within the range of receince device. However, its safety and effectiveness were demonstrated as a result of performance tests according to FDA guidance and ASTM F-4. Since the acceptance criteria of FDA guidance, and the comparison test result was equal to or geater than the predicate device (K092609), the difference of screw length is not a significant difference that raise questions of safety and effectiveness. # 9. Conclusions As a result of the substantial equivalence comparitily equivalent with the predicate device except for the product size. Therefore, the reference devices were added to support the difference of product size of subject device is covered in the range of the predicate device and the reference devices, except of screw length. However, it has been length does not rase questions of safety and effectiveness. In conclusion, the subject device, SIGNEX, is determined to the predicate device (K12324) and the reference devices (K14489, K192609).