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The Parcus Synd-EZ SS is intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. The Parcus Synd-EZ SS is intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of the syndesmosis (syndesmosis disruptions) in connection with Weber B and Weber C ankle fractures.

The Parcus Synd-EZ SS consists of two buttons with suture connecting them and are designed to be used for stabilizing the syndesmosis during healing. Building upon the technology of the Parcus Synd-EZ Ti, the Synd-EZ SS is easily adjusted for length and resists elongation without requiring knots to secure the fixation. The device is made from medical grade titanium, stainless steel and UHMWPE suture and is provided sterile.

The Parcus Titanium Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair

The Parcus Titanium Interference Screw is a cannulated, threaded, tapered fastener for use in interference fixation of ligaments and tendons in patients requiring ligament or tendon repair. The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136) and is available in sizes ranging from 7-12mm in diameter and 20-35mm in length.

The Parcus GFS II and GFS Mini are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The Parcus GFS Naked devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The GFS Ultimate devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The GFS BTB devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The Parcus ATLAS is indicated for adjunct fixation of the 1st and 2nd metacarpals in CMC arthroplasty. The Parcus Actiflip Naked, Actiflip Cinch, and Actiflip Whip are used for fixation of bone or soft tissue to bone, and is intended as fixation post, a distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications: anterior cruciate ligament, pectoralis repair (minor), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction. The Parcus GFS Ultimate Hip is used for fixation of soft tissue to bone in the hip and is indicated for ligamentum teres reconstruction. The Parcus Synd-EZ Ti are intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. The Parcus Synd-EZ Ti are intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of the syndesmosis disruptions) in connection with Weber B and Weber C ankle fractures.

The Parcus GFS II, GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip are a range of devices design for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. Each device is made from a medical grade titanium alloy, Ti-6AI4V ELI, and may also include an UHMWPE polyblend suture component. Each device is provided sterile.

The Parcus Miti Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications: Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC. The Parcus V-lox™ Titanium Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications: Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC. Hip: Acetabular Labral Repair

The Parcus Miti and V-lox Titanium Suture Anchors are a family of threaded, tapered fasteners for use in attachment of soft tissue to bone. The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136). It comes preloaded with either one, two, or three strands of sutures between 3-0 and #2 in size or suture tape between 1.4mm and 2.0mm wide. The suture and suture tape is available either with or without attached needles, and is provided sterile and attached to a driver. The Miti Suture Anchor is available in diameters of 2.0mm, 2.5mm and the V-lox Titanium Suture Anchor is available in diameters of 4.5mm, 5.0mm, 5.5mm and 6.5mm.

The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications: Shoulder Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair. Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, lliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair. Foot/Ankle Lateral Stabilization. Medial Stabilization. Midfoot Reconstruction. Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. Elbow Tennis Elbow Repair, Biceps Tendon Reattachment. Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC. Hip Acetabular Labral Repair

The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are tapered fasteners with an eyelet at the distal tip and circumferential barbs used to secure the implant in bone and provide suture fixation without the need for knot tying. After passing through the target tissue, sutures are passed through the distal eyelet of the anchor, it is pounded into place which secures both the anchor and the suture in place. This is the same design and insertion technique as the predicate Knotless PEEK CF Push-In Suture Anchors. The predicate device was originally provided in 3.5mm and 4.5mm diameters and this 510(k) will expand that size range to include 2.8mm and 5.5mm options. The Knotless PEEK Push-In Suture Anchor is made from polyetheretherketone (PEEK) and the Knotless PEEK CF Push-In Suture Anchors are made from carbon fiber polyetheretherketone (PEEK CF). The Parcus predicate device is comprised of carbon fiber polyetheretherketone (PEEK CF). The Parcus reference devices consist of devices comprised of either PEEK or PEEK CF. The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are provided sterile with a single use suture passer and either with or without a single use inserter.

The Parcus AcTiFlip is used for fixation of bone or soft tissue to bone, and is intended as fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications; anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction. The Parcus GFS Ultimate Hip is used for fixation of soft tissue to bone in the hip and is indicated for ligamentum teres reconstruction.

The Parcus AcTiFlip and GFS Ultimate Hip devices are designed for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The devices are made from medical grade titanium and UHMWPE suture and are provided sterile.

The Parcus Synd-EZ SS is intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. The Parcus Synd-EZ SS is intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of the syndesmosis (syndesmosis disruptions) in connection with Weber B and Weber C ankle fractures.

The Parcus Synd-EZ SS consists of two buttons with suture connecting them and are designed to be used for stabilizing the syndesmosis during healing. Building upon the technology of the Parcus Synd-EZ Ti, the Synd-EZ SS is easily adjusted for length and resists elongation without requiring knots to secure the fixation. The device is made from medical grade titanium, stainless steel and UHMWPE suture and is provided sterile.

The Parcus Knotless AP Suture Anchors are indicated for the attachment of soft tissue to bone. This product is intended for the following indications: | Shoulder | Rotator Cuff Repair, Acromioclavicular Separation Repair,<br>Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or<br>Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion<br>Repair. | |------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Knee | Medial Collateral Ligament Repair, Lateral Collateral Ligament<br>Repair, Posterior Oblique Ligament Repair, Extra Capsular<br>Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and<br>Tendon Avulsion Repair. | | Foot/Ankle | Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction,<br>Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal<br>Ligament Repair. | | Elbow | Tennis Elbow Repair, Biceps Tendon Reattachment. | | Hand/Wrist | Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral<br>Ligament Reconstruction, TFCC. |

The Parcus Knotless AP Suture Anchors consist of ribbed anchor bodies in 2.8mm, 4.5mm, and 5.5mm diameters. The anchor body is comprised of Parcus Medical's Advanced Polymer (AP) which is a formulation of ß-TCP and PLGA that has a proven record as a safe and effective absorbable material that has been used in the industry for over 10 years. This material has been developed such that it will maintain the necessary strength to insert successfully and provide the necessary resistance to pull-out long enough for the body to heal and then, over time, break down, be absorbed into the body and eventually replaced by bone. The presence of the osteoconductive ß-TCP will allow for boney replacement at the insertion site as the anchor is absorbed. Knotless AP Suture Anchors are provided with a single use suture threader and a single use driver. These devices are individually packaged and provided sterile.

The Parcus Synd-EZ Ti is intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. The Parcus Synd-EZ Ti is intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of the syndesmosis (syndesmosis disruptions) in connection with Weber B and Weber C ankle fractures.

The Parcus Synd-EZ Ti consists of two buttons with suture connecting them and are designed to be used for stabilizing the syndesmosis during healing. Building upon the technology of the Parcus GFS Ultimate, the Synd-EZ Ti is easily adjusted for length and resists elongation without requiring knots to secure the fixation. The device is made from medical grade titanium and UHMWPE suture and is provided sterile.

The Parcus ATLAS is indicated for CMC Arthroplasty.

The Parcus ATLAS is designed for use in CMC arthroplasty. The ATLAS is comprised of medical grade titanium, PEEK-OPTIMA™ from Invibio™, and UHMWPE. The ATLAS is provided sterile.