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The SF Push-in Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, wrist, elbow, knee, hip and shoulder. The SF Push-in Anchor is designed only to be inserted with the SupraFuser® Generator.

SF Push-in Anchor 1.6mm:
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, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
Elbow: Ulnar or Radial Collateral Ligament Reconstruction,
Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction,
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction,
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair.

SF Push-in Anchor 2.3mm:
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, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Triangular Fibrocartilage Complex (TFCC)
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collament Ligament Reconstruction, Lateral epicondylitis repair,
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction,
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Achilles Tendon Repair, Bunionectomy,
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis,
Hip: Acetabular labral repair, capsular repair.

SF Push-in Anchor 3.0mm and 3.6mm:
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, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Triangular Fibrocartilage Complex (TFCC)
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, lateral epicondylitis repair,
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, 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 and Varus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Metatarsal tendon repair, Bunionectomy,
Knee: Medial collateral ligament repair, lateral collateral ligament repair, patellar tendon repair, posterior oblique ligament repair, and iliotibial band tenodesis,
Hip: Acetabular labral repair, capsular repair.

The SF Push-in Anchor system consists of implantable anchors with 1.6, 2.3, 3.0 and 3.6mm diameter, an ultrasonic system, a sonotrode, dedicated anchor size specific drills and stoppers, a handpiece front cover, a guide with integrated wrench, and a set of reamers. The SF Push-in Anchors are delivered in a dedicated Implant Case to facilitate suture loading and suture handling during implantation. The SF Push-in Anchors are made of biocompatible and fully bioresorbable Poly-L-lactide-co-D,L-lactide. The SF Push-in Anchors are fully bioresorbable implants designed for soft tissue reattachment to bone by means of suture materials. The implantation process employs ultrasonic energy to liquefy the polymeric components of the Push-in Anchors at the interface with bone tissue. The liquid polymer flows into the marrow space of the surrounding cancellous bone, where it is immediately quenched and provides anchorage of the implant. The ultrasonic energy for the implantation of the Push-in Anchors is produced by the SupraFuser® ultrasonic generator and applied via the attached handpiece. The sonotrode is mounted on the handpiece. It transmits the ultrasonic vibrations to the Push-in Anchor. The drills and the stoppers are dedicated to be used with the Push-in Anchor of the respective size. The Geomax Reamer is used for the SF Push-in Anchors 1.6, 2.3 and 3.0 in cases of thick cortical bone or oblique insertion.

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HyperSuture™ All Green Extension sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.

The Threadstone HyperSuture All Green Extension cables, loops, and tapes are nonabsorbable, sterile, surgical sutures composed of multiple multifilament strands of ultrahigh molecular weight polyethylene (UHMWPE) braided together to form the implant.

HyperSuture All Green Extension cables and tapes are available in 36 inches and 40 inches in length. The loop configurations are available in 24" or 2" loop configurations. HyperSuture All Green Extension cable, loops, and tape sizes include USP #2-0, USP #0, USP #1, USP #2, USP #3, USP #5, and 1.0mm tape, 1.2mm tape, 1.5mm tape, 1.8mm tape, 2.0mm tape. All variations of the suture, cables, loops, and tapes, are available with or without pre-attached needles.

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The FiberTape Button is intended to be used for fixation of bone to bone or soft tissue to bone and is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering the FiberTape Button for primary or secondary fixation for ACL, PCL, MCL, POL, LCL, MPFL, ALL, PLC, Quadriceps Tendon, and Patellar Tendon repair and reconstruction and Iliotibial Band tenodesis.

The FiberTape Button is a suture-button construct comprised of a titanium button and nonabsorbable suture. The device is provided sterile and is single-use.

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Meniscus Versaflex is indicated for repair of the meniscus.

Meniscus Versaflex - All Inside Meniscal Suture with Bendable Tip is an arthroscopy suture, non-absorbable, assembled in an insertion device. The inserter mechanism can be molded for better access to the posterior areas, medium region and anterior third of meniscus, with use of a bending tool and the options (models) of general use and reverse. Each device has two implants of non-absorbable polymer PEEK, previously connected with a UHMWPE suture and pre-assembled in an insertion system. The inserter is offered in a curved and reverse curved configuration. It is provided in sterile condition sterilized by Ethylene Oxide.

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The Pre-Sutured Tendon is intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.

The Pre-Sutured Tendon is for single patient use only.

The Pre-Sutured Tendon is a donated human nonbone tendon pre-sutured with sterile Ultra-high-molecular-weight polyethylene (UHMWPE) nonabsorbable sutures. The tendon is processed via the BioCleanse® Tissue Sterilization Process (The BioCleanse Process). The Pre-Sutured Tendon device is offered as a single strand and as a quadruple (quad) strand.

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The ProZip Knotless Implant is intended for use in soft-tissue approximation.

The ProZip Knotless Implant is comprised of braided ultra-high molecular weight polyethylene (UHMWPE) and Polyester sutures. It contains one working suture, also referred to as the repair strand, and shuttle strand that is used to shuttle the repair strand around the tissue. Additionally, the repair strand has a suture attached at either end to aid in passing through tissue, known as adaptor tail.

Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

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The Arthrex SpeedFLEX™ Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The Arthrex SpeedFLEX™ Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including but not limited to reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The Arthrex SpeedFLEX™ Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.

The Arthrex SpeedFLEX™ Implant consists of a decellularized human allograft dermis that is pre-sutured with FiberWire® suture (passing suture) and TigerLink™ SutureTape (implanted). The allograft implant will be offered in four (4) sizes. The Arthrex SpeedFLEX™ Implant is sold sterile, single use.

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PowerKnot High Strength Suture is indicated for soft tissue approximation and/or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

PowerKnot High Strength Sutures are non-absorbable braided suture constructs made of 100% UHMWPE. They consist of a multifilament core yarn with a braided sheath and they are available in various color options, with or without a stainless steel needle. The PowerKnot High Strength Sutures portfolio also includes a Running Direction Indicator (RDI) surface of the suture, aiding the surgeon when applying the suture.

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The Dunamis Screws are intended to be used as stand-alone bone screws indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bone appropriate for the size of the device.

When used in conjunction with Dunamis Force DFX Suture or Suture Tape, the Dunamis Screw and Suture Locking System is intended to be used for fixation of bone-to-bone or soft tissue-to-bone. The components are intended to serve as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.

Specifically, Dunamis will be offering these devices for use in orthopedic procedures, such as ACL/PCL repair and reconstruction for the adult and pediatric patient population when the device does not bridge, disrupt, or interfere with the growth plate; MCL, POL, LCL repair and reconstruction; IBT and PRT repair; and MPFL, ALL, Quadriceps Tendon, PLC repair and reconstruction. When used in conjunction with the Dunamis Screws, the Suture Locking System can be used as a cerclage to treat bone fractures, such as patella, greater tuberosity, or olecranon fractures.

The Dunamis Screw and Suture Locking System is to be used for fixation of bone-to-bone or soft tissue-to-bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. The devices are intended to be used in the adult or pediatric patient population, when the device does not bridge, disrupt, or interfere with the growth plate.

The Dunamis Screw and Suture Locking System consists of standalone bone screws, and various components which are compatible with previously cleared Dunamis Fixation Button System, Force DFX sutures and suture tapes, including: screws with suture locking features and suture wheel with various adapter options. The standalone screws are provided in various diameters, lengths, and configurations including headed and headless styles with various overall and threaded lengths. Screws with suture locking features are available in various diameters, lengths, and configurations. The suture wheel is available for standalone use with sutures or for use with compatible orthopedic plates with two adapter options (threaded or non-threaded post). The new components are manufactured from stainless steel and titanium alloy.

This document is an FDA 510(k) clearance letter for a medical device called the "Dunamis Screw and Suture Locking System." It focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving a specific novel clinical performance or effectiveness through a clinical trial with acceptance criteria for an AI or software-based medical device.

Therefore, the requested information about acceptance criteria, AI performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI/software would not be applicable to this type of traditional medical device clearance.

The clearance letter primarily discusses:

• Intended Use and Indications: For bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation.
• Device Description: Consists of standalone bone screws and components compatible with previously cleared Dunamis systems, manufactured from stainless steel and titanium alloy.
• Predicate Devices: Several predicate devices are listed, including screws and suture systems.
• Performance Testing Summary: "Non-clinical performance data included ASTM F543 screw testing, static and dynamic construct testing, and engineering worst-case rationales." This indicates bench testing to demonstrate mechanical performance comparable to the predicates.
• Substantial Equivalence Conclusion: The device has the same intended use, similar technological characteristics, and similar materials to the predicate devices. Mechanical testing demonstrated substantially equivalent performance.

In summary, this 510(k) clearance is for a physical orthopedic implant system, not a software or AI-based medical device. The "acceptance criteria" here are met through demonstrating mechanical properties and performance that are substantially equivalent to already cleared devices, primarily via non-clinical bench testing.

Thus, a table of acceptance criteria for AI performance, details on test/training sets, expert adjudication, MRMC studies, or specific AI ground truth establishment methods are not present and not relevant to this 510(k) submission as described.

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The Riverpoint Medical HS Fiber® sutures are indicated for injury and/or reconstruction of soft tissue, excluding the ones listed in contraindications, where soft tissue ligation or approximation is required. The Riverpoint Medical HS Fiber® sutures are also indicated for conditions where allograft tissues are required to be fixated, such as ACL tears.

The Riverpoint Medical HS Fiber® sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber sutures are available in common sizes and lengths with or without pre-attached needles.

This FDA 510(k) clearance letter pertains to a surgical suture, the HS Fiber® Suture, and not an AI/ML powered device. Therefore, the request to describe acceptance criteria and a study proving device performance in the context of AI/ML (e.g., test set, ground truth, expert consensus, MRMC study, training set) cannot be fulfilled based on the provided document.

The document states: "The updates being proposed are limited to the labeling, no additional performance testing or biological evaluation was required." This indicates that no new performance studies (of any kind, let alone AI/ML specific ones) were conducted for this particular 510(k) submission (K252201). The device is deemed substantially equivalent to a previously cleared predicate device (K231163) based on the technological identity and minor labeling changes.

Therefore, I cannot provide the requested information for an AI/ML device from this document.

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