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The GRYPHON X Anchor is intended for: Shoulder: Biceps Tenodesis; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Medial Patellofemoral Ligament Reconstruction; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction The HEALIX TRANSTEND Anchor is intended for: Shoulder: Rotator Cuff, Partial Thickness Rotator Cuff, Biceps Tenodesis, Acromio-Clavicular Separation, Deltoid Repair; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Mid-Foot Reconstruction, Hallux Valgus Repair, Metatarsal Ligament/Tendon Repairs; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Lateral Epicondylitis Repair; Wrist: Scapholunate Ligament Reconstruction; Hip: Capsular Repair, Acetabular Labral Repair

The subject devices of this Traditional 510(k) are the GRYPHON X Anchors and the HEALIX TRANSTEND Anchors. The proposed GRYPHON X Anchor is suture anchor preloaded on a disposable inserter assembly and is intended for fixation of suture to bone for various orthopedic procedures. The proposed anchor will be available with various suture offerings: ORTHOCORD™ Suture, PERMACORD™ Suture, DYNACORD™ Suture, and PERMATAPE™ 1.3mm Suture, offered in either single strand or double strand configurations with needle attachments. The GRYPHON X Anchors are offered with either a push-in (“P”) or threaded (“T”) anchor design and are available in absorbable BIOCRYL RAPIDE (BR) (P and T anchors) or non-absorbable PEEK materials (P anchors only). The implant is supplied sterile, ready to use. The proposed HEALIX TRANSTEND Anchor is a suture anchor preloaded on a disposable inserter assembly and is intended for fixation of suture bone for various orthopedic procedures. This proposed device will be loaded with either one or two strands of PERMATAPE 1.3mm Suture and will be offered in PEEK material only. The implant is supplied sterile ready to use. The proposed GRYPHON X product portfolio also contains a reusable instrument sterilization tray with lid (sold separately) – it's intended to store and protect the reusable instruments during transport and sterilization

HEALIX ADVANCE Knotless anchors: The DePuy Mitek HEALIX ADVANCE Knotless BR anchors is indicated as follows: - · Shoulder: Rotator Cuff Repair - · Shoulder: Bicep Tenodesis - · Shoulder: Deltoid Repair - · Elbow: Ulnar Collateral Ligament (UCL) - · Elbow: Radial Collateral Ligament (RCL) - · Knee: Posterior Oblique - · Knee: Medial Collateral Ligament (MCL) - · Knee: Lateral Collateral Ligament (LCL) - · Knee: liotibial (IT) Band Tenodesis - · Knee: Anterior Cruciate Ligament (ACL) Repair - · Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair - · Knee: Meniscal Root Repair - · Foot and Ankle: Achilles Tendon Repair The DePuy Mitek HEALIX ADVANCE KNOTLESS PEEK Anchors is indicated as follows: - · Shoulder: Rotator Cuff Repair - · Shoulder: Bicep Tenodesis - · Shoulder: Deltoid Repair - · Elbow: Ulnar Collateral Ligament (UCL) - · Elbow: Radial Collateral Ligament (RCL) - · Knee: Posterior Oblique - · Knee: Medial Collateral Ligament (MCL) - · Knee: Lateral Collateral Ligament (LCL) - · Knee: liotibial (IT) Band Tenodesis - · Knee: Anterior Cruciate Ligament (ACL) Repair - · Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair - · Knee: Meniscal Root Repair - · Foot and Ankle: Achilles Tendon Repair - · Foot and Ankle: Lateral Stabilization - · Foot and Ankle: Medial Stabilization HEALIX ADVANCE Self-Punching anchors: The DePuy Mitek HEALIX ADVANCE SP Biocomposite Anchors is indicated as follows: - · Shoulder: Rotator Cuff Repair - · Shoulder: Bicep Tenodesis - · Shoulder: Deltoid Repair - · Elbow: Ulnar Collateral Ligament (UCL) - · Elbow: Radial Collateral Ligament (RCL) - · Knee: Posterior Oblique - · Knee: Medial Collateral Ligament (MCL) - · Knee: Lateral Collateral Ligament (LCL) - · Knee: liotibial (IT) Band Tenodesis - · Knee: Anterior Cruciate Ligament (ACL) Repair - · Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair - · Knee: Meniscal Root Repair The DePuy Mitek HEALIX ADVANCE SP PEEK Anchors is indicated as follows: - · Shoulder: Rotator Cuff Repair - · Shoulder: Bicep Tenodesis - · Shoulder: Deltoid Repair - · Elbow: Ulnar Collateral Ligament (UCL) - · Elbow: Radial Collateral Ligament (RCL) - · Knee: Posterior Oblique - · Knee: Medial Collateral Ligament (MCL) - · Knee: Lateral Collateral Ligament (LCL) - · Knee: liotibial (IT) Band Tenodesis - · Knee: Anterior Cruciate Ligament (ACL) Repair - · Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair - · Knee: Meniscal Root Repair - · Foot and Ankle: Achilles Tendon Repair - · Foot and Ankle: Lateral Stabilization - · Foot and Ankle: Medial Stabilization

The subject devices of this Special 510(k) are the HEALIX ADVANCE Knotless anchors and HEALIX ADVANCE Self-Punching (SP) anchors. The HEALIX ADVANCE Knotless Anchor is a one-piece implantable cannulated, threaded anchor designed to secure soft tissue to bone utilizing suture (provided separately). The anchor is preloaded on a disposable inserter shaft with handle, held in place by a #2 ORTHOCORD stay suture comprised of Ultra-High Molecular Weight Polyethylene (UHMWPE) and violet Polydioxanone (PDS). During implantation, the stay suture may be discarded or incorporated into the repair at the surgeon's discretion. The anchor is provided preloaded on a single-use driver. The anchor is offered in three sizes: 4.75mm, 5.5mm and 6.5mm. The anchors are available in two materials: Biocryl Rapide® (BR) and Polyetheretherketone (PEEK) materials. The Biocryl Rapide material is a biocomposite material of 70% PLGA copolymer (85% PLLA/15% PGA) and 30% β-TCP. The HEALIX ADVANCE KNOTLESS Anchor is provided sterile and is for single use only. The HEALIX ADVANCE SP Anchor is a two-piece "self-punching" design consisting of a cannulated, threaded anchor and dilator designed to secure soft tissue to bone utilizing suture (provided separately). The anchor-dilator are preloaded on a disposable inserter shaft with handle, held in place by a non-absorbable stay suture comprised of Ultra-High Molecular Weight Polyethylene (UHMWPE) and Green poly (ethylene terephthalate) (PET). During implantation, the stay suture may be discarded or incorporated into the repair at the surgeon's discretion. The HEALIX ADVANCE SP Anchor is offered in three sizes: 4.9mm, 5.5mm and 6.5mm. The anchors are available in two materials: Biocomposite (Biocryl) and Polyetheretherketone (PEEK) material. Biocryl is an absorbable biocomposite of Polylactic Acid (PLA) and Tricalcium Phosphate (TCP). The HEALIX ADVANCE SP Anchor is provided sterile and is for single use only.

MILAGRO ADVANCE PEEK Interference Screws (7x23mm, 8x23mm, 9x23mm): The DePuy Mitek MILAGRO ADVANCE PEEK Interference Screw is indicated as follows: · Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures. - · Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction - · Knee: Medial and lateral collateral ligament repair - · Knee: Medial patellofemoral ligament reconstruction (femur fixation) - · Shoulder: Proximal Biceps Tenodesis - · Elbow: Distal Biceps Tenodesis · Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction. Tendon Transfer in the Foot and Ankle MILAGRO ADVANCE PEEK Interference Screws (7x30mm, 8x30mm): The DePuy Mitek MILAGRO ADVANCE PEEK Interference Screw is indicated as follows: · Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures. · Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction · Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Recorstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle MILAGRO ADVANCE BR Interference Screws (7x23mm, 8x23mm, 9x23mm): The DePuy Mitek MILAGRO ADVANCE BR Interference Screw is indicated as follows: · Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures. - · Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction - · Knee: Medial and lateral ligament repair, medial patellofemoral ligament reconstruction (femur fixation) - Shoulder: Proximal Biceps Tenodesis - · Elbow: Distal Biceps Tenodesis · Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction. Tendon Transfer in the Foot and Ankle MILAGRO ADVANCE BR Interference Screws (8x30mm, 7x30mm): The DePuy Mitek MILAGRO ADVANCE BR Interference Screw is indicated as follows: · Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures. · Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction · Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Recor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle MILAGRO BR Interference Screws (7x15mm, 6x12mm, 5x12mm): The DePuy Mitek MILAGRO BR Interference Screws designed to attach soft tissues to bone in orthopedic surgical procedures for the following indications: · Shoulder: Proximal Biceps Tenodesis, Acromio-Clavicular Repair · Elbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament Repair · Knee: Collateral Ligament Repair, Medial Patellofemoral Ligament Reconstruction (patella fixation) · Foot and Ankle: Lateral Stabilization. Medial Stabilization. Mid-Foot Reconstruction. Tendon Transfer in the Foot and Ankle MILAGRO BR Interference Screws (5x23mm, 6x23mm, 6x30mm, 6x30mm): The DePuy Mitek MILAGRO Interference Screw is indicated as follows: - · Knee: (ST) graft to the tibia and/or femur during cruciate ligament reconstruction procedures - · Knee: Medial and lateral collateral ligament repair* - · Shoulder: Proximal bicep tenodesis * - Elbow: Distal bicep tenodesis* · Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Recor Hallucis Longus for Achilles Tendon Reconstruction. Tendon Transfer in the Foot and Ankle * These indications do not apply to 5x30mm Screws and 6x30mm Screws

The subject devices of this Special 510(k) are the MILAGRO Interference Screws and the Milagro ADVANCE Interference Screws. These interference screws are cannulated, threaded, tapered fasteners for use in interference fixation of soft tissue grafts and/or bone-tendon-bone grafts. The MILAGRO Interference Screws and MILAGRO ADVANCE Interference Screws are offered in varying sizing configurations. The devices are offered in absorbable Biocryl Rapide material which is a biocomposite material of 70% PLGA copolymer (85% PLLA/15% PGA) and 30% β-TCP or PEEK (Polyether ether ketone) material. The devices are provided sterile via Ethylene Oxide (EO) sterilization and are for single use only.

The FMS VUE™ Fluid Management and Tissue Debridement System is intended to provide controlled fluid distention and suction, controlled cutting, shaving and abrading of bone and tissue for use in arthroscopic surgery of the shoulder, knee, ankle, elbow, wrist and hip joints.

The FMS VUE Fluid Management and Tissue Debridement System is an arthroscopic pump system designed to provide optimal visibility of the surgical field by computer-controlled fluid regulation of intra-articular pressure, and flow during arthroscopic procedures. The system integrates a tissue debridement for controlled cutting, burring, shaving and abrading of bone and soft tissue. The FMS VUE Fluid Management and Tissue Debridement System consists of irrigation pump, which controls joint pressure, and the suction pump, which controls the flow of saline and waste from the joint. The FMS VUE Fluid Management and Tissue Debridement System includes an integrated shaver console, intended to provide controlled cutting, burring, shaving and abrading of bone and soft tissue. The FMS VUE Fluid Management and Tissue Debridement System is designed to work with the existing FMS VUE platform accessories including: foot pedal, remote hand control, shaver handpieces, FMS connect cable, tubing sets, blades, and burrs. The FMS VUE Fluid Management and Tissue Debridement System contains updates in the hardware, which include replaced near obsolescence components and new real panel connectors. The FMS VUE Fluid Management and Tissue Debridement System software modification includes an additional shaver oscillation profile algorithm.

Milagro Interference Screw (5x12, 6x12, 7x15, 8x15) The MILAGRO BR Interference Screws are designed to attach soft tissues to bone in Orthopedic surgical procedures for the following indications: Shoulder: Proximal Biceps Tenodesis, Acromio-Clavicular Repair Elbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament Repair Knee: Collateral Ligament Repair, Medial Patellofemoral Ligament Reconstruction (patella fixation) Milagro Advance Interference Screw (7x23, 8x23, 9x23) The MILAGRO ADVANCE Interference Screw is intended for attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures. Additionally, the 7, 8 and 9mm x 23mm screws are indicated for: medial and lateral ligament repart, medial patellofemoral ligament reconstruction (femur fixation) of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

The proposed devices are interference screws used for attachment of soft tissue to bone in Orthopedic surgeries. The proposed devices are cannulated, threaded interference screws, made of absorbable Biocryl® Rapide™ (composite of β-TCP and PLGA copolymer). The devices are provided as sterile (EtO), and are for single patient use only. There is no accessory accompanied with the devices. Manual Orthopedic instruments such as tap and driver are used for screw insertion. Instruments are classified as LXH: Orthopedic Manual Surgical Instruments, Class I Exempt device, regulated per 21 CFR 888.4540. No new instrumentation is developed for the purpose of this submission.

The VAPR Electrodes, for use with the VAPR VUE Radiofrequency System, are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.

The VAPR TRIPOLAR 90 Suction Electrode is a single use, one-piece bipolar RF suction electrode for use in a surgical setting by a surgeon trained in arthroscopic surgery. The VAPR TRIPOLAR 90 Suction Electrode is an RF device which incorporates 3 electrodes in the probe tip: one active electrode and two return electrodes. This configuration optimizes ablation and coagulation in a single device. It has been designed to facilitate access and control the delivery of RF energy to the joint space. The connector plug of the VAPR TRIPOLAR 90 Suction Electrode is designed to interface only with the VAPR VUE Radiofrequency Generator. It has an internal identification code which automatically adjusts the VAPR VUE Generator to the optimal default and accessible powers and waveforms. If required, the settings for the VAPR TRIPOLAR 90 Suction Electrode can be modified within safe pre-determined limits by accessing the generator or footswitch control. It is intended to be only operated with the VAPR VUE generator at pre-determined default settings specific for this device. The VAPR TRIPOLAR 90 Suction Electrode has three sets of buttons to address surgeon preference when holding the electrode. Each pair of buttons offers the same functionality and are ergonomically positioned for surgeon comfort. In addition the VAPR TRIPOLAR 90 Suction Electrode features vacuum fluid extraction which enhances the efficiency of the electrode and assists in the removal of bubbles and debris created during activation within the operating site. The design includes the ability to vary flow rate to allow the surgeon to make adjustments depending on particular procedural requirements.

The Healix Ti Anchor is intended for: - Shoulder: Rotator Cuff Repair, 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 - Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair - Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction - Hip: Capsular Repair, Acetabular Labral Repair

The Healix Ti™ Anchor with Permacord™ is a non-absorbable suture anchor preloaded on a disposable inserter assembly intended for fixation of suture to bone. The Healix Ti Anchors are manufactured of Titanium material. Permacord suture is non-absorbable. The anchor is provided in three sizes: 4.5mm, 5.5mm and 6.5mm. The Healix Ti Anchor with Permacord suture is supplied sterile and is for single use only.

The VAPR® ARCTIC™ Suction Electrode for use with the VAPR VUE® RF System is intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the hip.

The VAPR® ARCTIC™ Electrode is a single use, one-piece bipolar suction articulating electrode for use in arthroscopic surgery of the hip. The electrode has a hand-controlled articulating tip to improve access and suction capabilities. This will enhance the efficiency of the electrode and extend the utility of the system by assisting in the removal of bubbles and debris created during activation within the operating site. The ARCTIC Electrode has been designed to facilitate access and control the delivery of RF energy to the joint space. The plug of the ARCTIC Electrode is designed to fit the VAPR VUE® generator socket only. It has an internal identification capacitor code which automatically adjusts the VAPR VUE Generator to the optimal default and accessible powers and waveforms. If required, the settings for the device can be modified within safe pre-determined limits by accessing the generator or footswitch control. It is intended to be run only off the VAPR VUE electrosurgical generator at pre-determined default settings specific for the device.

Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction Hip: Capsular Repair, Acetabular Labral Repair

The proposed device is a suture-anchor to be used for soft tissue fixation to bone. The Gryphon Anchor is a cannulated, ribbed anchor, made of either non-absorbable PEEK (Polyetheretherketone) or absorbable Biocryl® RapideTM (composite of β-TCP and PLGA copolymer). Size #1 blue Permacord™ suture (UHMWPE braided suture) is preloaded on the anchor. The suture incorporates a pre-tied sliding knot (ProKnot knot). The Permacord suture is a non-absorbable suture that conforms to USP except for oversized diameter. The device is provided as sterile; the device is for single patient use only.