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Found 11 results
510(k) Data Aggregation
K Number
K210159Device Name
IntraLock System
Manufacturer
Fusion Orthopedics, LLC
Date Cleared
2021-07-23
(183 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Fusion Orthopedics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IntraLock System is indicated for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures, and nonunions of the small bones and joints of the foot. The two-part construct is specifically intended for use in Talonavicular, Calcaneocuboid, and Metatarsocuneiform arthrodesis.
Device Description
The IntraLock System is a three-part construct, consisting of a Locking Lag Screw of 2 diameters and lengths ranging from 22mm to 55mm, a Setting Screw of 1 diameter with lengths ranging from 14mm to 24 mm, as well as a mating washer component consisting of 1 diameter and lengths ranging from 20mm to 28mm. The IntraLock Implants are constructed of titanium alloy (TI6AI4V). The specialized instruments are primarily made of surgical grade stainless steel (per ASTM F899) with certain components made from aluminum alloy (Al6061).
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K Number
K193377Device Name
TopLock Anchor System
Manufacturer
Fusion Orthopedics, LLC
Date Cleared
2020-11-25
(356 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Fusion Orthopedics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TopLock Anchor System is intended to secure soft tissue to bone of:
The Shoulder:
Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation, Rotator Cuff Repair, Capsule Repair, Biceps Tenodesis. Deltoid Repair
The Elbow:
Ulnar or Radial Collateral Ligament Reconstruction, Bicep Tendon Reconstruction, Tennis Elbow Repair
The Hand and Wrist:
Scapholunate Ligament Reconstruction, Ulnar / Radial Collateral Ligament Reconstruction, Extensor Tendon Repair, Flexor Tendon Repair
The Knee:
Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Tendon Repair
The Ankle and Foot:
Lateral Ligament Stabilization Repair, Medial Ligament Stabilization Repair.
Achilles Tendon Repair / Reconstruction, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Mid and Rear Foot Reconstruction
Device Description
The TopLock Anchor System consists of a collection of barbed suture anchors, manufactured from medical grade Polyetheretherketone or PEEK (ASTM F2026). The anchors are offered from diameters of 3.5mm to 5.0mm with each size offering two eyelet size options to accommodate suture and suture tape. The size range and configurations are offered for surgical treatment of ligament, tendon and soft tissue pathologies of the shoulder and other joints. The specialized instruments are made primarily of surgical grade stainless steel (ASTM F899).
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K Number
K202959Device Name
PolyLock Plating System
Manufacturer
Fusion Orthopedics, LLC
Date Cleared
2020-11-24
(55 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Fusion Orthopedics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PolyLock System is indicated for use in the treatment of bone fractures, arthrodesis, osteochondritis, and interfragmentary indications in the small bones of the hand and foot. Including, fusions of the forefoot and midfoot, stabilization of 1st, 2nd, 4th, and 5th tarsometatarsal fusions, intercuneiform, navicular-cuneiform, talo-navicular, calcaneo-cuboid, and medial column fusions, first metatarsal osteotomies for hallux valgus/rigidus correction, first metatarsal fracture fixation, arthrodesis of the first metatarsal cuneiform joint, and arthrodesis/fusion of the first metatarsophalangeal joint.
Device Description
The PolyLock Plating System consists of various shapes and sizes of plates for the management of small bone orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact plate capable of dynamic/manual compression, with threaded screw holes accepting both poly-axial and locking screws. The system also consists of poly-axial and locking screws with diameters consisting of 2.0mm, 2.4mm, 2.7mm, 3.5mm and 4.0mm with lengths from 8mm to 60mm. System instrumentation includes: drill bits, countersinks, K-wires, olive wires, depth gauges, reamers, driver shafts, guides, plate benders, clamps, and driver handles to facilitate the placement of the screws. The implants are intended for single use only. Instruments designed for bone removal are intended for single use only, such as: drill bits, countersinks, reamers, K-wires, and olive wires.
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K Number
K192323Device Name
PolyLock Small Bone Plating System
Manufacturer
Fusion Orthopedics, LLC
Date Cleared
2019-11-18
(83 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Fusion Orthopedics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PolyLock System is indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochondritis, and interfragmentary indications in the small bones of the hand and foot. Including, fusions of the forefoot and midfoot, stabilization of 1st, 2nd, 3rd, 4th, and 5th tarsometatarsal fusions, intercuneiform, navicular-cuneiform, talo-navicular, calcaneo-cuboid, and medial column fusions, first metatarsal osteotomies for hallux valgus/rigidus correction, first metatarsal fracture fixation, arthrodesis of the first metatarsal cuneiform joint, and arthrodesis/fusion of the first metatarsophalangeal joint.
Device Description
The PolyLock System consists of various shapes and sizes of plates for the management of small bone orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact plate capable of dynamic/manual compression, with threaded screw holes accepting both poly-axial and locking screws. The system also consists of poly-axial and locking screws with diameters consisting of 2.0mm, 2.4mm and 2.7mm and lengths from 8mm to 26mm. System instrumentation includes: drill bits, countersinks, K-wires, olive wires, depth gauges, reamers, driver shafts, guides, plate benders, clamps, and driver handles to facilitate the placement of the screws. The implants are intended for single use only. Instruments designed for bone removal are intended for single use only, such as: drill bits, countersinks, reamers, K-wires, and olive wires.
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K Number
K190136Device Name
Fusion Silastic System
Manufacturer
Fusion Orthopedics, LLC
Date Cleared
2019-10-21
(265 days)
Product Code
KWH
Regulation Number
888.3720Why did this record match?
Applicant Name (Manufacturer) :
Fusion Orthopedics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GAIT Implants are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narrowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAIT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the hallux to the first metatarsal.
The GAIT Implants w/Grommets are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the first metatarsal.
The GAIT 2.0 Implants are intents presenting with class 3 degeneration of the first metatarsophalangeal joint with narrowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAIT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the hallux to the first metatarsal.
The GAIT 2.0 Implants w/Grommets are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the first metatarsal.
The SHIP Long Implants, are intents presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impaired function and stability; Pain; Impaired toe length ratio.
The Shaw Rod Implant is intended for patients presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impared function and stability; Pain; Impaired toe length ratio.
The SHIP Short Implants are intents presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impaired function and stability; Pain; Impaired toe length ratio.
Device Description
The Fusion Silastic System consists of a collection of flexible toe joint prostheses, manufactured from medical grade silicone (ASTM F2042). The product family is offered in five configurations to address varying indications and patient anatomy; the Gait Implant, the Gait 2.0 Implant, the SHIP Long Implant, the SHIP Short Implant and the Shaw Rod. The specialized instruments are made primarily of surgical grade stainless steel (ASTM F899).
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K Number
K182342Device Name
IntraLock Lapidus System
Manufacturer
Fusion Orthopedics, LLC
Date Cleared
2019-05-21
(266 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Fusion Orthopedics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IntraLock Lapidus System is indicated for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures, and nonunions of the small bones and joints in the foot. The two-part construct is specifically intended for use in Talonavicular, Calcaneocuboid, and Metatarsocuneiform arthrodesis.
Device Description
The IntraLock Lapidus System is a two-part construct, consisting of a lag screw of two diameters and lengths ranging from 22mm to 50mm, as well as a mating washer component consisting of one diameter and lengths ranging from 16mm to 35mm. The IntraLock Implants are constructed of titanium alloy (TI6AI4V). The specialized instruments are made of surgical grade stainless steel (ASTM F899).
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K Number
K182684Device Name
HammerTechTM Fixation System
Manufacturer
Fusion Orthopedics, LLC
Date Cleared
2018-11-23
(58 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Fusion Orthopedics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HammerTech device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
Device Description
The HammerTech Fixation System consists of PEEK (Polyetheretherketone (ASTM F2026)) and titanium alloy (Ti6Al4V ELI (ASTM F136)) threaded bone implants intended for fixation of the interphalangeal joint of the lesser toes. The device is offered in three configurations; straight cannulated PEEK, straight cannulated titanium, and angled solid titanium. Each configuration is offered in five different sizes to address to a variety of patient anatomy. The specialized instruments are made primarily of surgical grade stainless steel (ASTM F899). The implant and associated instrumentation is supplied sterile and non-sterile.
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K Number
K181815Device Name
DynaBridge
Manufacturer
Fusion Orthopedics, LLC
Date Cleared
2018-10-15
(98 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Fusion Orthopedics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DynaBridge is indicated for:
- · Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
- · Fixation of proximal tibial metaphysis osteotomy.
- · Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
· Fixation of small bone fragments (i.e. Small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna, or radius in the upper extremittes; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.
Device Description
The DynaBridge Superelastic Nitinol Implant is a Nickel-Titanium alloy (Nitinol) bone implant intended primarily for fixation of fractured, osteotomy, and arthrodesis of the hand, foot, and bone appropriate for the size of the device. The implant is offered in a range of sizes to address a variety of indications and patient anatomy with bridge sizes from 9mm to 25mm. The system is offered sterile and non-sterile.
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K Number
K170624Device Name
TalarLift STS
Manufacturer
Fusion Orthopedics, LLC
Date Cleared
2017-08-11
(162 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Fusion Orthopedics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TalarLift STS arthroereisis implant is designed for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequelae. The TalarLift STS is intended for the following pathological conditions resulting from disease, injury, or other trauma:
• Hypermobile pes valgus;
• Posterior tibial tendon dysfunction;
• Severe pronation;
• Subtalar instability;
• Hypermobile flexible congenital flat foot.
Device Description
The TalarLift STS consists of a threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, and corresponding instrumentation to facilitate insertion. The system consists of three configurations, conical, cylindrical, and anatomic. All three devices are manufactured from titanium alloy (Ti-6Al-4V) complying with ASTM F136.
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K Number
K170038Device Name
FuzeFix Screw System
Manufacturer
Fusion Orthopedics, LLC
Date Cleared
2017-08-07
(214 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Fusion Orthopedics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FuzeFix Mini System is intended for use in the stabilization of bone fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, and arthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Mini System is indicated for: scaphoid fractures, metacarpal fractures, phalangeal fractures, ulnar styloid fractures, small ioint fusions, humeral head fractures, intercarpal fractures, tarsal fusions, patellar fractures, interfragmentary ulnar fractures, small hand and wrist bone fractures, forefoot interfragmentary fractures, trapezial fractures, metatarsal fractures, radial head fractures, osteo-chondral fractures, interphalangeal fractures, malleolar fractures, metaphyseal fractures, interfragmentary radius fractures, distal metatarsal osteotomies, midfoot interfragmentary fractures. Not intended for use in the spine.
The FuzeFix Large System is intended for use in the stabilization and fixation of bone fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, and arthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Large System is indicated for: joint reconstructions, joint fusions, multiple fragment joint fractures, simple metaphyseal fractures of the wrist, ankle, elbow, and shoulder, metatarsal fractures and other fractures of the foot, ligament fixation of the proximal humerus, malleolar fractures, navicular fractures of the calcaneus, fractures of the talus, arthrodesis of the ankle joint, and fractures of the tarsal region. The devices and implants are not intended for use in the spine.
The FuzeFix Headless FT System is intended for use in the stabilization and fixation of bone fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, and arthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Headless FT System is indicated for: Osteochondral fragments (talar vault, femoral condyle), apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal), cancellous fragments (talus), Carpal, meta-carpal, and small hand bone, tarsal and metatarsals, phalanges, Intra-articular fractures, ankle, proximal and distal humerus, proximal and distal radius, proximal and distal ulna, osteochondral fixation and fractures, Osteochondritis Dissecans, Fixation of fractures and osteotomies about the knee, Oblique fractures of the fibula, Reconstructive surgeries of the foot, and malleolar fixation. Not intended for use in the spine.
The FuzeFix Twist Off System is intended for use in the stabilization of bone fractures. osteotomies, and for bone reconstruction of the hand and foot. The FuzeFix Twist Off System is indicated for: fixation of small bone fragments, Weil osteotomy, mono-cortical fixation, osteotomies and fractures fixation in the foot and hand.
Device Description
The FuzeFix Screw System consists of headed and headless, partial and full threaded cannulated, self-compressive screws and snap off screws and washers for the management of orthopedic osteotomies and trauma. The screws are self-drilling, self-tapping. The system consists of multiple screw lengths and diameters, and the necessary instruments to facilitate the placement of these implants.
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