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510(k) Data Aggregation
K Number
K250712Device Name
Linkt Compression Staple System
Manufacturer
Trax Surgical
Date Cleared
2025-05-14
(65 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Product Code :
JDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Linkt™ Compression Staple System is intended to be used for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
Device Description
The Linkt Compression Staple System consists of individually packaged, sterile, bone staple implants and a separate single use, sterile instrument set. The implants are manufactured from a nickel titanium alloy (Nitinol) which meets the requirements of ASTM F2063. The staples utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. The staples are available in sizes ranging from 9mm x 9mm to 20mm x 20mm to allow the surgeon to select the appropriate device for the patient's anatomy.
The single use instruments are intended to prepare the site and deploy the staple. The instrument kit includes a drill, drill guide, locating pins and an insertion tool.
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K Number
K243888Device Name
Medline UNITE® REFLEX® Hybrid Nitinol Implant System
Manufacturer
Medline Industries, LP
Date Cleared
2025-04-11
(114 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Product Code :
JDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medline UNITE® REFLEX® Hybrid Nitinol Implants are intended to provide fixation for fractures, fusions or osteotomies of the bones of short (tarsals) and long (metatarsals, phalanges, distal tibia and fibula) bones comprising the foot and ankle such as: First metatarsal-cuneiform arthrodesis, First metatarsophalangeal arthrodesis, Talo-Navicular Fusion, Lis-Franc arthrodesis, Scarf and Chevron osteotomies. Implants are intended for single use only.
The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the Medline UNITE® REFLEX® Hybrid Nitinol Implant. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Device Description
The Medline UNITE® REFLEX® Hybrid Nitinol Implants are manufactured from nickel titanium alloy (nitinol). The implants utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. Chemical etching and passivation are common processes to create a uniform oxidation layer on the surface of the implant. The system includes implants offered in various styles, sizes, and options; each designed for specific anatomy and procedures. The implants can accommodate Ø2.7mm, Ø3.5mm, and Ø4.0mm locking and non-locking cortical screws to be used with the polyaxial locking holes and compression slots. The system also includes reusable and disposable instrumentation necessary for implantation of the REFLEX® Hybrid Nitinol Implant.
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K Number
K243742Device Name
Arthrex DynaNite Nitinol Staples
Manufacturer
Arthrex Inc.
Date Cleared
2025-01-31
(58 days)
Product Code
JDR, JDQ
Regulation Number
888.3030Why did this record match?
Product Code :
JDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Arthrex DynaNite Nitinol Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
The Arthrex DynaNite Nitinol Staples are 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 femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
• When used with Arthrex FiberTape Cerclage System, the Arthrex DynaNite Nitinol Staple (sizes 13x10 and 15x12 only) is intended for sternotomy indications including the "rewiring" of osteotomized sternums.
Device Description
The Arthrex DynaNite Nitinol Staples are Nickel Titanium (Nitinol) bone fixation devices intended to be permanently implanted. The implant is formed with two legs connected by a bridge and is offered in multiple combinations of bridge widths, leg lengths, and cross sections to accommodate various anatomy.
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K Number
K243658Device Name
TMC Compression Implant System
Manufacturer
Treace Medical Concepts
Date Cleared
2024-12-26
(29 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Product Code :
JDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K242415Device Name
TMC Compression Implant System
Manufacturer
Treace Medical Concepts
Date Cleared
2024-09-06
(22 days)
Product Code
JDR, HRS, HWC
Regulation Number
888.3030Why did this record match?
Product Code :
JDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The system is intended to be used for fracture fixation, and joint arthrodesis of the foot and ankle.
Device Description
TMC Compression Implant System is comprised of staple implants and related instrumentation for implantation. The implants are offered in multiple combinations of bridge lengths, leg lengths, cross sections, and cannulated versions to accommodate various anatomies. This includes two (2x1) or four (2x2, 4x1) legged implants. It also includes locking screws for additional fixation. All implantable components are manufactured from implant grade titanium alloy (Ti-6A1-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.
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K Number
K240212Device Name
COGNiTiON Staple System
Manufacturer
Ortho Solutions UK Ltd.
Date Cleared
2024-02-23
(29 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Product Code :
JDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ortho Solutions COGNITiON™ Staple System is indicated for hand and foot bone fragments, osteotomy, fixation and joint arthrodesis. The COGNiTiON™ Staple System is not intended for spinal use.
Device Description
The COGNITION Staple System is comprised of a set of implantable metallic (Superelastic NiTi Alloy per ASTM F2063) staples and accessory instrumentation. The system consists of a series of two and four-leg staples of various bridge and leg lengths. Each staple is provided to the user in a relaxed state with the staple legs in a converging position. During the staple insertion step, the provided staple driver is used to splay the staple legs, allowing for implantation across the fracture, fusion, or osteotomy site. The staple legs then have the inherent propensity to converge due to the superelastic nature of the NiTi material. This stability is intended to allow for bone healing to occur.
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K Number
K232990Device Name
ATOMIC Nitinol Fixation System
Manufacturer
RMR Ortho, LLC
Date Cleared
2024-01-12
(112 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Product Code :
JDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The A'TOMIC™ Nitinol Fixation System is indicated for use in fracture, osteotomy fixation and joint arthrodesis as well as fixation of bone fragments (i.e., small fragments of bone which are not comminuted to the extent that preclude staple placement). The device is intended for use in short, long, or flat bones. The A'TOMIC Nitinol Fixation System is intended for single use only.
Device Description
The A TOMICTM Nitinol Fixation System, which consists of the A TOMIC™ Nitinol Fixation System implant and associated instruments, is intended for use for fixation and compression and supports several surgical techniques (e.g., fracture, osteotomy, joint arthrodesis, and fixation of bone fragments). The staples are made of implant-grade Nitinol (ASTM F2063-18) and are designed to exhibit superelastic properties at room temperature. This allows for continued compression to be applied across bone segments, thus enhancing long-term stability, and promoting fusion. Implants are passivated per ASTM F86 following machining to create a surface oxide layer that is resistant to corrosion which ensures the biocompatibility of the implant. Each staple is pre-loaded on an inserter for implantation and sterile packed. The staples are available in multiple sizes, varying by bridge length and leg length, to accommodate individual patient anatomy. Single-use disposable instrumentation is provided to assist in the surgical placement of the A TOMICTM Nitinol Fixation System implant. Reusable instrumentation will also be available as an option for the surgeon and facility.
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K Number
K230724Device Name
arcad® 2.0 Duo & Quadro osteosynthesis compressive staples
Manufacturer
Novastep
Date Cleared
2023-12-04
(263 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Product Code :
JDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
arcad® 2.0 Duo & Quadro osteosynthesis compressive staples are indicated for foot bone fragments osteotomy fixation and joint arthrodesis.
Device Description
arcad® 2.0 Duo & Quadro osteosynthesis compressive staple implants with two-leg and four-leg configurations with multiple bridge and leg lengths. The implants are manufactured from nickel-titanium alloy (ASTM F2063). The system is provided as a single-use sterile pack comprising of a bone staple implant ready to implant assembled in open legs position on its dedicated disposable insertor forceps and instruments for implantation. The implant is designed to facilitate bone fusion with Nitinol pseudoelastic behavior.
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K Number
K232905Device Name
Medline UNITE® REFLEX® Nitinol Staple Kit
Manufacturer
Medline Industries, LP
Date Cleared
2023-10-19
(30 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Product Code :
JDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medline UNITE® REFLEX® Nitinol Staples are intended to provide fixation for fractures of the bones of the hand and foot such as: First metatarsalcunerform arthrodesis, First metatarsophalangeal arthrodesis, Talo-Navicular Fusion, LisFranc arthrodesis, Akin osteotomy, Scarf and Chevron osteotomies. Staples are intended for single use only.
Device Description
The Medline UNITE® REFLEX™ Nitinol Staples are manufactured from nickel titanium alloy (Nitinol). The staples utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. Chemical etching and passivation are common processes to create a uniform oxidation layer on the surface of the implant. The kits includes staples offered in a range of sizes from 8mm x 8mm to 25mm x 25mm. The Medline UNITE® REFLEX® Nitinol Staples are offered in three different bridge widths. The MINI features a 1.5mm bridge width, the MAX has a 4.0mm bridge width and the ULTRA has a 5.0mm bridge width. The MAX and ULTRA staples have a chamfer on the bridge that is not present on the MINI version of the staples.
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K Number
K232324Device Name
StealthFix Intraosseous Fixation System
Manufacturer
Medartis Inc.
Date Cleared
2023-08-30
(27 days)
Product Code
JDR, HWC
Regulation Number
888.3030Why did this record match?
Product Code :
JDR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The StealthFix Intraosseous Fixation System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including:
- · Arthrodesis in hand or foot surgery
- · Mono or bi-cortical osteotomies in the foot or hand
- · Fracture management in the foot or hand
- · Distal or proximal metatarsal or metacarpal osteotomies
- · Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.
Device Description
The StealthFix Intraosseous Fixation System is an orthopedic intraosseous staple system consisting of staple and screw implants. The staples consist of two legs or posts connected by a bridge. The staples are available in post diameters of 2.5mm(mini), and 4.5mm(standard). The 2.5mm staples are provided with a bridge span of 10mm and range in post length from 8mm to 12mm. The 3.5mm staples are provided with a bridge span of 15mm and range in post length from 14mm to 20mm. The 4.5mm staples are available in bridge spans of 15mm and range in post length from 14mm to 32mm. The system provides crossing screws for optional fixation with the standard staple implants. Standard staples are designed with a screw slot to accept a crossing screw. The screws are available partially and fully threaded and are 3.5mm in diameter with lengths ranging from 16mm to 38mm in 2mm increments. The partially threaded screws are headed. The fully threaded and headless. The system provides accessory instruments designed for preparation of the and insertion of implants into bone, including implant specific inserters and targeting arms. The implants of the system are available packaged both sterile for single use. The instruments are provided non-sterile, reusable or single be cleaned and sterilized by the end user prior to use. The system also provides some instruments sterile packaged, individually and in sets. Sterile instruments are for single use only.
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