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510(k) Data Aggregation
K Number
K242995Device Name
OIC Small / Mini Fragment Plate System
Manufacturer
The Orthopaedic Implant Company
Date Cleared
2024-10-23
(27 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
The Orthopaedic Implant Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OIC Small / Mini Fragment Plate System is indicated for the fixation of fractures, mal-unions, non-unions or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.
Device Description
The OIC Small / Mini Fragment Plate System consists of titanium plates including the Distal Radius, Clavicle, Proximal Humerus, Tibia and Distal Fibula, 1/3 tubular, Hook, Olecranon and Mini Fragment, bone screws and instruments for implantation. The plates come in a variety of sizes and are pre-contoured to match the anatomy of the patient and accept 2.5mm and 3.5mm bone screws are available in three diameters (2.0mm, 2.5mm and 3.5mm) and range in length from 6mm to 130mm. The bone screws are available with both threaded (locking) and non-threaded (non-locking) heads. The OIC Small / Mini Fragment Plate System is made of titanium alloy in compliance with ASTM F1472 or ASTM F67. The OIC Small / Mini Fragment Plate System is provided non-sterilized by the medical facility prior to implantation.
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K Number
K182736Device Name
OIC Suture Anchor System
Manufacturer
The Orthopaedic Implant Company
Date Cleared
2018-12-28
(91 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
The Orthopaedic Implant Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OIC Suture Anchor System is intended for fixation of soft tissue to bone and will support the following procedures: Shoulder - Rotator cuff repair, biceps tenodesis. Elbow - Biceps tendon reconstruction. Knee - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar tendon repair, iliotibial band tendonesis joint capsule repair.
Device Description
The OIC Suture Anchor System consists of anchors and instruments to aid in implantation. The anchors are a screwlike device manufactured from PEEK plastic which are implanted into bone. Each anchor is 15mm in diameter and has an eyelet at the top that is used as an attachment point for sutures are used to fasten soft tissues to facilitate healing. Sutures are not included in the system. Instruments include an anchor driver, 5.5mm punch/tap, suture threader and tray. The instruments are made from stainless steel and aluminum.
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K Number
K181184Device Name
OIC Intramedullary Nail System
Manufacturer
The Orthopaedic Implant Company
Date Cleared
2018-07-27
(85 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
The Orthopaedic Implant Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OIC Intramedullary Nail System is intended for surgical management of femoral and tibial fractures including open and closed fractures, pseudarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, tumor resections, nonunions and malunions. The hip nay be used for basilar neck, subtrochanteric and intertrochanteric fractures. The femoral nails may be used for fractures of the femur below the hip joint including ipsilateral femur fractures, fractures proximal to a total knee arthroplasty and supracondylar fractures, including those with intra-articular extension.
Device Description
The OIC Intramedullary Nail System consists of the tibia and femur, nail locking bolts, lag screws and instruments for implantation. The nails come in a variety of sizes and are pre-contoured to match the anatomy of the patient and accept 5.0mm locking bolts range in length from 20mm to 130mm. The lad screws are 10.5mm in diameter and range in length from 70mm to 120mm.
The intramedullary nails, bolts and screws are made of titanium alloy Ti-6Al-4V ELI.
The additional instruments being added to the OIC Intramedullary Nail System are provided in the non-sterile condition. They are made of surgical grade stainless steel or 6061-T6 Aluminum with a medical grade silicone or Radel handle.
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K Number
K160222Device Name
OIC Cervical PEEK Spacer
Manufacturer
THE ORTHOPAEDIC IMPLANT COMPANY
Date Cleared
2016-12-07
(313 days)
Product Code
ODP
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
THE ORTHOPAEDIC IMPLANT COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cervical PEEK Spacer is indicated for intervertebral body fusion of the cervical spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The Cervical PEEK Spacer is intended for use at one level in the cervical spine, from C3 to TI, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cervical PEEK Spacer is intended to be used with a supplemental internal fixation system.
Device Description
The Cervical PEEK Spacer is a polyetherether cervical interbody fusion spacer. The device comprises a closed annular ring and hollow center for placement of bone graft and sawtooth "teeth" on the inferior and superior surfaces and expulsion. The device includes a radiopaque marker pin position wall of the device. The device is offered in two footbrints (depth x width, 9.5mm x 15mm), one lordotic angle (7°) and heights ranging from 6mm to 10mm in 1mm increments.
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K Number
K123832Device Name
OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME
Manufacturer
THE ORTHOPAEDIC IMPLANT COMPANY (OIC)
Date Cleared
2013-03-20
(97 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
THE ORTHOPAEDIC IMPLANT COMPANY (OIC)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
a: Distal Radius Plates are indicated for the fixation of Intra- and extra-articular fractures and ostectomies of the distal radius.
b. Clavice plates are indicated for the fixation of fractures, mal-unions, non-unions and ostectomies of the clavicie.
c. Proximal Humerus plates are indicated for the fixation of fractures, fracture dislocations, non-unions and osteotomies of the proximal humerus, particularly in the osteopenic bone.
Device Description
Not Found
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K Number
K113123Device Name
OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM
Manufacturer
THE ORTHOPAEDIC IMPLANT COMPANY
Date Cleared
2012-01-12
(83 days)
Product Code
KTT, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
THE ORTHOPAEDIC IMPLANT COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
a. OIC Cannulated Screw System is used for adult and pediatric patients as indicated for pelvic, small and longbone fracture fixation. OIC 6.5/7.3mm cannulated screws are indicated for large bones and large bone fragments such as ankle arthodeses, intercondylar femur fractures, pediatric femoral neck fractures (6.5mm cannulated screws only), sacroiliac joint disruptions, and subtalar athrodeses. OIC 4.0mm cannulated screws are indicated for the fracture fixation of small bones and small bone fragments such as metatarsal and phalangeal osteotomies, fractures of the tarsals and metatarsals, tarsometatarsal and metatarsophalangeal athrodeses, osteochondritis dissecans, and other small fragment cancellous bone fractures.
b. The OIC Sliding Hip Screw (SHS) System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in subtrochanteric, intertrochanteric, and basilar neck fracture. The SHS is indicated for stable fractures, and unstable fractures in which a stable medial buttress can be reconstructed. The SHS provides controlled collapse and compression of fracture fragments. This results in stable fixation and prevents undue stress concentration on the implant.
Device Description
Not Found
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