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510(k) Data Aggregation
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(58 days)
The Arthrex Lateral Proximal Tibia Plate is indicated for adult patients, as well as patients with osteopenic bone. It is indicated for fixation of fractures of the tibia.
The Arthrex Medial Proximal Tibia Plate is indicated for adult patients, as well as patients with osteopenic bone. It is indicated for fixation of fractures of the tibia.
The Arthrex Posteromedial Proximal Tibia Plates are intended to be used for internal bone fixation for bone fractures in the tibia.
The Arthrex Variable Angle (VA) Proximal Tibia Plating System is designed for repairing fractures of the tibia. The Arthrex Variable Angle (VA) Proximal Tibia Plating System consists of two Lateral Proximal Tibia Plate types (Standard and High), Posteromedial Proximal Tibia Plates, and Medial Proximal Tibia Plates. The Lateral Proximal Tibia Plates are anatomically contoured, available in left and right configurations, varying plate lengths of 78 mm to 239 mm. The primary difference between the Standard and High Lateral Proximal Tibia Plates is that the High Lateral Proximal Tibia Plate includes four additional 2.7 mm screw holes proximally. The Medial Proximal Tibia Plates are anatomically contoured, available in left and right configuration, and varying plate lengths of 94 mm to 202 mm. The Posteromedial Proximal Tibia Plates are anatomically contoured straight plates offered in varying plate lengths of 87 mm to 137 mm. The Lateral, Posteromedial, and Medial Proximal Tibia Plates within the Arthrex Variable Angle (VA) Proximal Tibia Plating System accept variable angle (VA) and nominal angle locking screws, KreuLock™ screws, cortical screws, as well as cancellous screws. Additionally, the Variable Angle (VA) Proximal Tibia Plates includes K-wire holes for temporary fixation and suture holes to assist in soft tissue management. The proposed plates are manufactured from titanium alloy (Ti-6AL-4V ELI) conforming to ASTM F136 (ISO 5832-3). The Variable Angle (VA) Proximal Tibia Plates are single use and sold either sterile (Gamma) or non-sterile.
The Arthrex Variable Angle (VA) Proximal Tibia Plating System are compatible with the following Arthrex Screws:
- 2.7 mm Cortical Screw and 2.7 mm VAL Screw (K220937)
- 2.7 mm VAL KreuLock Screws (K242554)
- 3.0 mm Low Profile VA Locking Screw (K213837)
- 3.0 mm KreuLock™ Compression Screw, 3.0 Low Profile VA Locking Screw, Hybrid, 3.0 mm Hybrid KreuLock™ Compression Screw (K242554)
- 3.5 mm Low Profile Screw (K203294, K150456, K143614, K123241, K111253, K103705)
- 3.5 mm Low Profile Locking Screws (K150456, K143614, K111253, K103705)
- 3.5 mm Variable Angle Locking (VAL) Screw, Reinforced, 3.5 mm Variable Angle Locking (VAL) KreuLock™ Screw, Reinforced, 3.5 VAL Screw, 3.5 mm VAL KreuLock Screws (K241592)
- 4.0 mm Low Profile Screw, Cancellous (K150456, K143614, K111253, K103705)
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(131 days)
The Anatomic Lapidus Plates and I-Beam Lapidus Plates are intended for use in stabilization of fresh fractures, revision procedures, osteotomies, joint fusion and reconstruction of small bones and bone fragments of the foot.
The Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates consists of a series of plates of varying sizes, orientations, and lengths. The proposed plates are available in small, medium, and long, and left and right configurations. The proposed plates (I-Beam Lapidus Plates only) include an internal beam. Each plate provides locking screw fixation. The proposed plates are manufactured from titanium alloy conforming to ASTM F136. The proposed plates are sold sterile (gamma) and are single-use. The proposed Anatomic Lapidus Plates are sold as standalone, whereas the I-Beam Lapidus Plates are packaged as a kit with instrumentation.
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(26 days)
The Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm is intended to be used for suture or tissue fixation in the foot/ankle and hand/wrist. Specific indications for use are listed below:
- Hand/Wrist: Repair of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits and Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty)
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus Reconstruction
The proposed Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm is a knotless, two-component suture anchor consisting of a fully threaded and vented anchor body and a closed eyelet. The anchor and eyelet are manufactured from polyetheretherketone (PEEK Optima per ASTM F2026). The anchor and eyelet are preassembled on a disposable inserter with a suture threader. Arthrex recommends the use of the Arthrex 1.3 mm SutureTape (sold separately) previously cleared within Arthrex SutureTape (K193575). The proposed device is offered sterile, single-use, and is packaged in a single-pack (one per box).
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(28 days)
The Syndesmosis TightRope PRO is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the Syndesmosis TightRope PRO is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.
The Syndesmosis TightRope PRO devices are comprised of various configurations of two metal buttons (round and oblong) preloaded onto an inserter with #5 suture (implanted) and #2-0 FiberWire suture (passing suture), a one-hole washer or two-hole buttress plate. The proposed Syndesmosis TightRope PRO devices will utilize the existing #5 suture (implanted) and two-hole buttress plate previously cleared within K201522 – Arthrex Syndesmosis TightRope XP Buttress Plate Implant System. The proposed Syndesmosis TightRope PRO devices may be packaged as standalone devices or together with ancillary instruments to aid in insertion.
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(96 days)
The Arthrex BioComposite 2.0 mm SutureTak Suture Anchor is intended for suture (soft tissue) fixation to bone in the elbow, shoulder, hand/wrist, foot/ankle, knee, and hip in the following procedures:
- Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- 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
- 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
- Hip: Acetabular Labral Repair and Reconstruction
The Arthrex PEEK Mini Hip SutureTak is intended to be used for suture (soft tissue) fixation to bone in the hip. Specifically, Acetabular Labral Repair and Reconstruction.
The fundamental technology of the Arthrex SutureTak Suture Anchor is that the Arthrex SutureTak Suture Anchors are "hard-bodied" fixation devices with anchors manufactured from either BioComposite or PEEK material. The subject anchors are preassembled to suture manufactured from UHMWPE and Polyester. The anchor is first impacted into a pilot hole. Once the anchor is set, the suture is passed around the soft tissue and is fixated via its surgical technique. The devices are provided sterile, are single-use, and are packaged in a dual barrier packaging configuration.
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(111 days)
The Arthrex Synergy Vision imaging system is intended to provide visible light imaging in a variety of diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery.
The Arthrex Synergy Vision imaging system is indicated for use to provide real-time visible and near-infrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the system enables surgeons to perform open and minimally invasive surgery using standard endoscope visible light as well as visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the Arthrex Synergy Vision imaging system is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. Additionally, the system is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgical procedures.
Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex Synergy Vision imaging system is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved label, the Arthrex Synergy Vision imaging system is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
The Arthrex NanoNeedle Scope when used with the Synergy Vision imaging system is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery. For pediatric patients, the Arthrex NanoNeedle Scope is indicated for laparoscopy and orthopedic procedures.
The Arthrex 4K Open Scope 0° NIR is intended to be used as an accessory with the Synergy Vision imaging system to provide visible light imaging and near-infrared fluorescence imaging during open surgical procedures.
The Synergy Vision Imaging System includes a camera control unit (CCU) console, camera head, scope, and a laser light source. The system provides real-time visible light and near-infrared (NIR) illumination and imaging.
The Synergy Vision Imaging System uses an integrated LED light to provide visible light illumination and imaging of a surgical site. For NIR imaging, the system interacts with the laser light source to visualize the presence of a fluorescence contrast agent, indocyanine green (ICG) and pafolacianine. The contrast agent fluoresces when illuminated through the scope with NIR excitation light from the laser light source and the fluorescent response is then imaged with the camera, processed, and displayed on a monitor.
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(36 days)
The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the elbow, shoulder, hand/wrist, foot/ankle, knee, and hip the following procedures:
- Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Hand/Wrist: Scapholunate 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, Carpal Ligament Reconstruction and Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty)
- 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
- Hip: Acetabular Labral Repair and Reconstruction
The fundamental technology of the Arthrex FiberTak Suture Anchors is that the Arthrex FiberTak Anchors are "all-suture" soft-tissue fixation devices with a push-in design. The subject device is FiberTak Anchor with 1.3 mm SutureTape (White/Blue) and is a knotted FiberTak with a Polyester Sheath and a Polyester/UHMWPE repair suture.
The subject device is preloaded on a disposable inserter, which facilities deployment. The subject anchor and connected sutures are impacted into a pilot hole. The suture is then manually tensioned to set the anchor by "bulging/bunching" the suture sleeve within the pilot hole. Once the anchor is set, the suture is passed around the soft tissue and is fixated via its surgical technique. The device is provided sterile and is intended for single-use.
The provided FDA 510(k) Clearance Letter concerns a physical medical device (suture anchor) and not an AI/Software as a Medical Device (SaMD). Therefore, the questions related to AI acceptance criteria, training sets, ground truth establishment by experts, MRMC studies, and stand-alone algorithm performance are not applicable to this document.
The clearance for the Arthrex FiberTak Suture Anchor is based on substantial equivalence to existing predicate devices, primarily demonstrated through performance testing rather than clinical study data from image analysis or diagnostic tasks.
Here's an analysis of the provided text based on the nature of the device:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Mechanical Performance: Equivalent or superior mechanical properties (e.g., pull-out strength, fixation strength) to predicate devices in relevant anatomical applications for soft tissue-to-bone fixation. | Straight Pull testing (method based on ASTM F3690) was conducted.The test data demonstrates that the subject device performs statistically equivalent to the predicate and reference devices for the intended indications for use. |
| Biocompatibility: Materials are biocompatible for implantation. | Not explicitly detailed in the provided text, but assumed to be part of the predicate device's established safety profile, or covered by material specifications not included here. |
| Sterility: Device is sterile for single-patient use. | The device is provided sterile and is intended for single-use. |
| Design/Technology Equivalence: Fundamental technology, design, and operating principles are equivalent to predicate devices. | The subject Arthrex FiberTak Suture Anchor is identical to the primary predicate Arthrex FiberTak Suture Anchor except that it is seeking the additional Acetabular Labral Reconstruction indication.The subject Arthrex FiberTak Suture Anchor and reference device Smith & Nephew Microraptor Knotless Suture Anchor have similar technologies.Any differences between the subject and predicate devices are considered minor and do not raise any new or different questions concerning safety or effectiveness. |
| New Indication Equivalence: The new indication (Acetabular Labral Reconstruction) is supported by equivalence to a predicate/reference device that already has this indication. | The reference device, Smith & Nephew Microraptor Knotless Suture Anchor, has Acetabular Labrum Reconstruction indication, which is equivalent to the indication Arthrex is seeking. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text. The document states "Straight Pull testing... was conducted." For mechanical testing, the "sample size" would refer to the number of anchors tested, which is typically outlined in the test report referenced (ASTM F3690).
- Data Provenance: Not specified. It's likely that the testing was performed in a lab setting (in vitro) to regulatory standards (ASTM F3690). This is not retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device clearance based on mechanical testing and substantial equivalence, not on diagnostic accuracy established by expert consensus. There is no "ground truth" established by experts in the context of image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As per point 3, there is no expert panel or image interpretation data that would require adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context refers to the objective mechanical performance characteristics of the device (e.g., force at failure, displacement) as measured by standardized engineering tests (e.g., ASTM F3690). The "truth" is derived from these empirical measurements, not expert interpretation of clinical data.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not a machine learning model.
9. How the ground truth for the training set was established:
- Not Applicable. There is no "training set" or "ground truth" in the context of machine learning for this device.
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