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The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.

The Y-Knotless™ Flex Anchors may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor systems thereby stabilize the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The Y-Knotless™ Flex Anchors may be used in the following orthopedic procedures:

1. Shoulder Labrum
2. MPFL Reconstruction
3. Foot and Ankle
4. Biceps
5. Meniscal Root Repair

The Y-Knotless™ Flex Anchors are a non-absorbable, all-suture, knotless implant, that are supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10-6. The implant anchors are composed of a white flat braided ultra-high molecular weight polyethylene (UHMWPE) suture anchor, a tapered #2 Hi-Fi® repair suture either white/black or green/white/black, and a #2-0 Hi-Fi® shuttle suture, blue and black. The implants are pre-loaded on a disposable driver with sutures cleated to the handle. The anchors require a 1.8 mm pre-drilled bone hole created using Class I, exempt instrumentation.

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The Aevumed PROTEKT™ Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular 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

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

Hip: Capsular repair, Acetabular Labral Repair

The Aevumed PROTEKT™ Sutures Anchor with HS Fiber™ suture is a suture anchor manufactured from polyetheretherketone (PEEK) material and are preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. The Aevumed PROTEKT™ Suture Anchors is available in diameter size: 6.5 mm. It is offered sterile and is for single use only.

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The QuadLock™ Fixation System is intended for fixation of suture/tape (soft tissue) to bone during surgical procedures, in skeletally mature pediatric and adult patients for the following indications for use:

• Knee:

• ACL/PCL Repair: using non-absorbable UHMWPE USP #2 sutures or larger, or non-absorbable UHMWPE 1.4mm tapes or larger.
• ACL Reconstruction: using non-absorbable UHMWPE USP #2 sutures or larger, or non-absorbable UHMWPE 1.4mm tapes or larger.

QuadLock™ Fixation System is a medical device designed for fixation of suture and/or tape (soft tissue) to bone during surgical procedures.

QuadLock™ Fixation System is a medical device comprised of an implantable device supplied with specific single-use surgical accessories to facilitate its implantation. The implant component consists of a PEEK Cap and a Titanium Alloy Screw. The Cap component is inserted into a bone tunnel in a press fit manner through which the sutures and/or tape are threaded. The Screw component screws onto the Cap, securing the sutures/tapes in place in ACL/PCL repairs or ACL reconstruction surgery.

QuadLock™ Fixation System is currently available in 3 different sizes: 9 mm, 10mm and 11mm. QuadLock™ Fixation System is supplied sterile, sterilized via Ethylene Oxide.

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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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The Tigon Medical Knotless and Dual Javelin All-Suture Anchors are an extension to the Tigon Medical All-Suture Anchor line cleared in K242529 (December 20, 2024). The Tigon Medical Javelin All-Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:

• 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 Repair
• Hand/Wrist: Scaphulolunate 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 Repair
• 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: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair

The Tigon Medical Knotless and Dual Javelin All-Suture Anchors are an extension to the Tigon Medical All-Suture Anchor line cleared in K242529 (December 20, 2024). The Knotless Javelin All-Suture Anchor serves as a soft tissue fixation device that enhances surgical efficiency by eliminating the need for knot tying. The Dual Javelin All-Suture Anchor enhances the line by creating a double sock, knotless construct, eliminating the steps of tying a knot and passing suture through tissue. The devices are UHMWPE per ASTM F2848, permanent, soft-tissue fixation devices provided EtO sterilized and preloaded on an inserter. The anchors, available in 1.6 mm, 2.3 mm, and 2.6 mm sizes, come in various load configurations consisting of one or more working sutures, USP 2 suture cable, 1.5 mm suture tape, USP 5 suture cable, and/or 2 mm suture tape. The anchors can be implanted via self-punching or drilling and are intended to deploy under the cortical layer of the bone. The inserters can be reprocessed after use and are made from stainless steel. The device is intended for single-use in a surgical setting.

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The GMReis Suture Anchors is intended to be used for soft tissue reattachment in the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip. Specific indications are listed below:

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, 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, 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: Capsular repair, acetabular labral repair.

The Suture Anchors, manufactured by GM dos Reis Industria e Comercio Ltda, are anchor-type implants, and are manufactured in PEEK (polyetheretherketone). The anchors are made available preloaded in a disposable inserter device, composed of a metal rod and a polymeric handle. The implant and disposable inserter devices are unique products and cannot be sold separately. Implants of the Suture Anchors are classified as surgically invasive, non-absorbable, and non-active implantable medical devices. In addition, the implants, as well as the inserter device, are for single-use and sold in sterile form by Ethylene Oxide.

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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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The Aevumed FASE™ Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular 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

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

Hip: Capsular repair, Acetabular Labral Repair

The Aevumed FASE™ Sutures Anchor with HS Fiber™ suture is a suture anchor manufactured from polyetheretherketone (PEEK) material and are preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. The Aevumed FASE™ Suture Anchors are available in diameter sizes: 4.75mm and 5.5mm. They are offered sterile and are for single use only.

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The Mini Superhawk Suture Anchors are intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, 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, Bunionectomy, Digital Tendon Transfers.

• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.

• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.

• Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

• Hip: Capsular Repair, Acetabular Labral Repair.

The Mini Superhawk Suture Anchors are anchor devices comprised of polyether ether ketone (PEEK) material that are designed for the fixation of soft tissue to bone. The subject Mini Superhawk system features one 3.75mm diameter Screw-in (start) suture anchor preloaded on an inserter with a 1.5mm suture tape and one knotless 3.75mm diameter Push-in suture anchor preloaded on an inserter with a suture pull tab. The Push-in anchor also includes an auxiliary #0 suture that holds the anchor in place on the inserter until use and is then discarded. The Mini Superhawk Suture Anchors and inserters are assembled as a kit and provided to the end user sterile via ethylene oxide (EO) sterilization.

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The SutureTech All-Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip 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 Repair.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-Foot Reconstruction, Metatarsal Ligament Repair, Digital Tendon Transfers.

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Repairs.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair.

The All-Suture Dual Anchor System is intended to fixate soft tissue to bone. The device consists of an implant and a set of single use instruments. The implant is available in two configurations to accommodate varying clinical needs: the implant may be used knotted or knotless. The implant and single use instruments are provided ethylene oxide (EO) sterilized and packaged together.

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