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The OSSIOfiber® Suture Anchors are indicated for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, in the following procedures: - **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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy. - **Knee:** Anterior Cruciate Ligament Repair (4.75-5.5 Anchors Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair and Meniscal Root Repair. Secondary or adjunct fixation of ACL/PCL reconstruction or repair (4.75 – 5.5 Anchors only). - **Hand/Wrist:** Scapholunate Ligament Reconstruction, Ulnar or Radial Collament Reconstruction. - **Elbow:** Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair (Tennis Elbow).

The OSSIOfiber® Suture Anchor consists of an eyelet and anchor body preloaded on an inserter. The anchor body and eyelet are made from poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. OSSIOfiber® implants have been shown to be biocompatible. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the bone. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery. Sutures, needles and suture snare may also be provided with the device depending on configuration. The OSSIOfiber® Suture Anchors are sterile, single-use, and non-pyrogenic.

The Knotilus+ Biocomposite Knotless Anchor is intended to be used for soft-tissue to bone fixation in the shoulder, foot and ankle, knee, hand and wrist, elbow, and hip in skeletally mature pediatric and adult patients. It is indicated for use in the following procedures: **2.4x11.3mm, 2.9x12.5mm, and 2.9x15.5mm:** - **Shoulder:** Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift, or Capsulolabral Reconstruction - **Foot and Ankle:** Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament and Tendon Repair - **Knee:** Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis - **Hand and Wrist:** Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction - **Elbow:** Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair - **Hip:** Acetabular Labral Repair **2.4x8.9mm:** - **Hip:** Acetabular Labral Repair

The Knotilus+ Biocomposite Knotless Anchors are hard-body, push-in, knotless bone anchors. The subject device is comprised of a poly-ether-ether-ketone (PEEK) eyelet and poly-L-lactide ("PLLA") and beta-tricalcium phosphate ("β-TCP") anchor body, pre-assembled onto a disposable stainless-steel inserter, which enables insertion of the anchor into bone after creation of a pilot hole. The devices are single use, provided sterile, and are packaged in sterile barrier systems (SBS).

The Stryker AlphaVent™ Knotless SP Biocomposite Anchor is intended to be used for soft-tissue to bone fixation in the shoulder, foot and ankle, knee, hand and wrist, elbow, and hip in skeletally mature pediatric and adult patients. It is indicated for use in the following procedures: - **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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair - **Knee:** Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Secondary or Adjunct Fixation for ACL/PCL Reconstruction or Repair, Meniscal Root Repair, MPFL Repair/Reconstruction - **Hand/Wrist:** Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction - **Elbow:** Biceps Tendon Reattachment, Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair - **Hip:** Capsular Repair, Acetabular Labral Repair, Gluteus Medius Repair, Proximal Hamstring Repair

The AlphaVent Knotless SP Biocomposite Anchors (herein referred to as the subject device(s)) are bone anchors with a screw-in mechanism. The subject device is comprised of a poly-ether-ether-ketone (PEEK) eyelet and a biocomposite (Poly-L-lactic Acid (PLLA)/beta-tricalcium phosphate (β-TCP)) anchor body, pre-assembled onto a disposable stainless-steel inserter, which enables insertion of the anchor into bone either via a self-punching mechanism or after creation of a pilot hole. The devices are single use, provided sterile, and are packaged in sterile barrier systems (SBS).

The OSSIOfiber® Suture Anchors 2.5-3.5 mm, are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder, in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation. Specific indications are listed below: • **Shoulder:** Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, AcromioClavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction • **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, Joint Capsule Closure • **Hand/Wrist:** Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers • **Elbow:** Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair (Tennis Elbow)

The OSSIOfiber® Suture Anchor 2.5-3.5 mm, consists of an anchor preloaded on an inserter. The anchor is made from poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the bone. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery. Sutures, needles and suture snare may also be provided with the device depending on configuration. The OSSIOfiber® Suture Anchors 2.5-3.5mm are supplied sterile, for single patient use only. The OSSIOfiber® Suture Anchors 2.5-3.5mm are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.

The Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder. Specifically, rotator cuff repairs.

The Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is a fully threaded knotless suture anchor that is pre-loaded on a disposable inserter with Arthrex sutures. The anchor may be manufactured from either BioComposite (PLLA/betaTCP TriCalcium Phosphate) or PEEK (Polyether-ether-ketone). The Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is provided sterile (Ethylene Oxide), single-use, and is packaged in a single-pack or 5-pack.

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

The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure: shoulder, foot/ankle, knee, hand/wrist and elbow. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction 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 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 Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

The Fix2Lock (Bioabsorbable bone anchor) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery. This product consists of an absorbable and/or non-absorbable suture and driver shaft and handle.

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.

The Arthrex AlloSync™ PushLock® suture anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, Superior Labrum from Anterior (SLAP) Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

The Arthrex AlloSync™ PushLock® Suture Anchor is a two-component suture anchor comprised of a hollow anchor body manufactured from human cortical bone, a Polyetheretherketone (PEEK) eyelet, and a disposable driver inserter. The anchor will be offered in a 2.9mm diameter and 12.5mm in total length (anchor + eyelet). The anchor is sold sterile, single-use.