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510(k) Data Aggregation
K Number
K243469Device Name
SIGNEX
Manufacturer
OSTEONIC Co., Ltd.
Date Cleared
2025-05-29
(202 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
OSTEONIC Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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, 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, 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, non-unions, malunions 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, non-unions, malunions 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, non-unions, malunions and reconstructions. The SIGNEX Femur System is indicated for fixation of femur fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Clavicle System is indicated for fixation of clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Universal Plates are indicated for fixation of arm (humerus, radius, ulna), leg (femur, tibia, fibula), and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions.
Device Description
This product is intended for closure /or bone fixation of fractures, fusion, osteotomies, non-union, malunion and reconstruction of hand, wrist, forearm, elbow, humerus, foot, fibula, tibia, femur and clavicle.
This is comprised of plates and screws. The plates are made of Pure Titanium (ASTM F67) or Ti-6Al-4V ELI Titanium alloy (ASTM F136), and screws are made of Ti-6Al-4V ELI Titanium alloy (ASTM F136).
The plates and screws are single-use only, non-sterile products. So, those must be sterile before use.
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K Number
K243467Device Name
Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
Manufacturer
OSTEONIC Co., Ltd.
Date Cleared
2024-12-03
(25 days)
Product Code
MAI, MBI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
OSTEONIC Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure:
shoulder, foot/ankle, knee, hand/wrist and elbow.
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Device Description
The Fix2Lock (Bioabsorbable bone anchor) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.
This product consists of an absorbable and/or non-absorbable suture and driver shaft and handle.
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K Number
K243470Device Name
Fix2Lock (PEEK Self Punching)
Manufacturer
Osteonic Co., Ltd.
Date Cleared
2024-12-03
(25 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Osteonic Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; Orthopedic surgery for shoulders, knees, foot/ankle, hand/wrist and elbow.
Device Description
This product is used for orthopedic surgery, which soft tissue fix such as ligaments, tendons, and capsules to bone. The implant part is made of PEEK (polyether ether ketone, ASTM F2026) with non-absorbable suture and consists of Driver Handle and Driver Shaft for anchor insertion. This product is sterilized product and single use only.
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K Number
K230546Device Name
SIGNEX
Manufacturer
OSTEONIC Co., Ltd.
Date Cleared
2024-06-11
(469 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
OSTEONIC Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
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K Number
K233659Device Name
Suture Wing
Manufacturer
OSTEONIC Co., Ltd.
Date Cleared
2023-12-26
(41 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
OSTEONIC Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Suture wing is intended for fixation of soft tissue to bone, using suture, in orthopedic surgery.
Device Description
This product is used for orthopedic surgery, which soft tissue fix such as ligaments, tendons, and capsules to bone. The anchor and sutures is made of non-absorbable and consists of Driver Shaft for anchor insertion. This product is sterilized product and single use only.
Sterile bone anchor-all suture is supplied EO gas sterile state and it was packed in tyvek and PE film.
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K Number
K231322Device Name
Fix2Lock(PEEK Self Punching)
Manufacturer
Osteonic Co., Ltd.
Date Cleared
2023-06-07
(30 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Osteonic Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; Orthopedic surgery for shoulders, knees, foot/ankle, hand/wrist and elbow.
Device Description
This product is used for orthopedic surgery, which soft tissue fix such as ligaments, tendons, and capsules to bone. The implant part is made of PEEK (polyether ether ketone, ASTM F2026) with non-absorbable suture and consists of Driver Handle and Driver Shaft for anchor insertion. This product is sterilized product and single use only.
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K Number
K231326Device Name
Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)
Manufacturer
Osteonic Co., Ltd.
Date Cleared
2023-05-31
(23 days)
Product Code
MAI, MBI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Osteonic Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; shoulder, foot/ankle, knee, hand/wrist and elbow.
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Device Description
The Fix2Lock (Bioabsorbable bone anchor) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery. This product consists of an absorbable and/or non-absorbable suture and driver shaft and handle.
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K Number
K210360Device Name
Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
Manufacturer
Osteonic Co., Ltd
Date Cleared
2022-01-27
(353 days)
Product Code
GWO, GXR, HBW
Regulation Number
882.5320Why did this record match?
Applicant Name (Manufacturer) :
Osteonic Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.
Device Description
The Neuro Plating System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and in 3 colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.95mm in lengths of 3.0 to 6.0mm. It is made of Ti-6Al-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, green and gold) by anodizing.
Neuro Plating System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The plate is placed on the fractured bone and the screw is inserted into the bone through a plate hole to fix. If necessary, the plate may be bent or cut to meet the anatomical needs of patient.
The Neuro Plating System has two types of sterilization method; Neuro Plating System is non-sterile state packed in PE bag which must be sterilized before use and Neuro Plating System - Sterile Kit is provide sterile state with gamma sterilization packed in Tyvek and PET. Both are single use only.
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K Number
K211992Device Name
Ortho MI System
Manufacturer
Osteonic Co., Ltd.
Date Cleared
2021-10-15
(109 days)
Product Code
OAT
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Osteonic Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ORTHO MI SYSTEM is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. It is intended for single use only.
Device Description
The ORTHO MI SYSTEM is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. It is intended for single use only.
The screw diameters and lengths vary as shown below. It is made of a machined piece of Ti-6Al-4V ELI titanium alloy (ASTM F 136-13).
| Structure (head type) | Thread diameter and Length | Remark |
|-----------------------|-------------------------------|------------------------------------------------|
| Double head | - Ø1.4mm, 6.0/8.0mm | Exceptionally S5T (Double head) and S5R (Slot) |
| Button head | - Ø1.6mm, 6.0/8.0/10.0mm | are Ø1.8mm, 10.0 to 16.0mm per 1.0mm. |
| Wing | - Ø1.8mm, 6.0/8.0/10.0mm | |
| Slot | - Ø2.0mm, 6.0/8.0/10.0/12.0mm | |
These size combinations are the same across all model types (Double Head, Wing, Slot) with exception case.
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K Number
K210122Device Name
Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)
Manufacturer
Osteonic Co., Ltd.
Date Cleared
2021-08-27
(220 days)
Product Code
MAI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Osteonic Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sterile bioabsorbable bone screw (Biocomposite ACL screw) is a fixation screw that fixes soft tissue such as ligaments, tendons, and the articular capsules to bone, and is used in orthopedic surgery(Cruciate ligament reconstruction procedures).
Device Description
The Sterile bioabsorbable bone screw (Biocomposite ACL screw) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.
The implanted screw is made of poly(L-lactide-co-glycolide), PLGA and tri-calciumphosphate(S-TCP). Poly(L-lactide-co-glycolide), PLGA is gradually decomposed in vivo by hydrolysis and eventually excreted in carbon dioxide and water. Tri-calciumphosphate(ß-TCP) is gradually degraded in vivo by hydrolysis and eventually re-used as a calcium source.
Sterile bioabsorbable bone screw (Biocomposite ACL screw) is supplied EO gas sterile state and it is packed in Aluminum Pouch.
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