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510(k) Data Aggregation
K Number
K232941Device Name
Megaloop Button System
Manufacturer
Date Cleared
2024-05-03
(226 days)
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Suzhou Endophix Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Megaloop Button System - Megaloop Button with Megaloop Adjustable Loop
The device is intended to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction.
Megaloop Button System - Megaloop AD Device
The device is intended to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction.
Megaloop Button System - Megaloop FLB Device, Megaloop FLW Device, Megaloop XL Button
Megaloop FLB Device and Megaloop FLW Device are used for fixation of soft tissue to bone in orthopedic procedures such as ACL repair.
When used in conjunction with the Megaloop FLB Device or Megaloop FLW Device, the Megaloop XL Button is intended for fixation of soft tissue to bone in orthopedic procedures such as ACL repairs.
Megaloop Button System - Megaloop DB Device, Megaloop AC Button with Megaloop Adjustable Loop
The Megaloop DB Device and Megaloop AC Button are 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 Megaloop DB Device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.
- The Megaloop AC Button is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
Device Description
The Megaloop Button System is a family of titanium buttons for the fixation of bone to bone or soft tissue to bone. The system includes a variety of buttons made of Ti-6AI-4V ELI titanium alloy, with or without pre-assembled nonabsorbable loops, sutures and needles. The loops and sutures are offered in non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) material. The long straight needles are offered in XM-16 stainless steel material. The sutures and needles are not implantable and are discarded after assisting with button placement.
The Megaloop Button System is provided sterile, non-absorbable, for single use only.
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K Number
K232725Device Name
Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor
Manufacturer
Date Cleared
2023-11-02
(57 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Suzhou Endophix Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Javelot Ti and Javelot Ti-D Suture Anchor are intended for connection and fixation of soft tissue to bone in the knee, hip, shoulder, elbow, ankle, foot, wrist and hand for the following indications: Shoulder: - · Bankart lesion repair - · SLAP lesion repair - · Acromio-clavicular separation repair - · Rotator cuff tear repair - · Capsular shift or capsulolabral reconstruction - · Biceps tenodesis - · Deltoid repair Foot and Ankle: - Hallux valgus repair - · Medial or lateral instability repair/reconstruction - · Achilles tendon repair/reconstruction - · Midfoot reconstruction - · Metatarsal ligament/tendon repair/reconstruction Elbow, Wrist and Hand: - Ulnar or radial collateral ligament reconstruction - · Lateral epicondylitis repair - · Biceps tendon reattachment - · Scapholunate ligament reconstrontion (not for 4.5-6.5mm pro anchors) Knee: - · Extra-capsular repair - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament - · Iliotibial band tenodesis - · Patellar realignment and tendon repair - Vastus medialis obliquus advancement Hip: (2.8-6.5mm anchors only) - · Capsular repair - · Acetabular labral repair
Device Description
Javelot titanium anchors and sutures are preassembled onto an inserter, which enables insertion of the anchor into bone. After the anchor is fully seated, the inserter is removed from the implant site, leaving the anchor in the bone and the suture looped through the anchor. Javelot titanium suture anchors come in various configurations, including: with attached non-absorbable needle(s). In certain configurations, the Javelot titanium suture anchors are packaged with a drill, a drill guide and a drill guide handle. The anchors are offered in titanium material. The sutures are offered in non-absorbable USP braid Ultra High Molecular Weight Polyethylene (UHMWPE) material. The preassembled inserter consists of an insertion rod and an insertion handle, the insertion rods are offered in stainless steel material, the insertion handles are offered in polycarbonate (PC) material. The needles are offered in 302 stainless steel material, the drills are offered in 630 stainless steel material, the drill guides are offered in 304 stainless steel material, and the drill guide handles are offered in polyphenylsulfone (PPSU) material. Javelot titanium suture anchors are provided sterile, non-absorbable, for single use only.
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K Number
K231002Device Name
Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)
Manufacturer
Date Cleared
2023-06-07
(61 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Suzhou Endophix Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Javelot PK-S suture anchor is intended for the reattachment of soft tissue to bone for the following indications: Shoulder: -Bankart lesion repair -SLAP lesion repair -Acromioclavicular separation repair -Rotator cuff tear repair -Capsular shift or capsulolabral reconstruction -Biceps tenodesis -Deltoid repair Foot/Ankle: -Hallux Valgus repair -Medial or lateral instability repair/reconstruction -Achilles tendon repair/reconstruction -Midfoot reconstruction -Metatarsal ligament/tendon repair/reconstruction Elbow: -Ulnar or radial collateral ligament reconstruction -Lateral epicondylitis repair -Biceps tendon reattachment Knee: -Extra-capsular repair Medial collateral ligament Lateral collateral ligament Posterior oblique ligament -Iliotibial band tenodesis -Patellar realignment and tendon repair Vastus medialis obliquus advancement
The Javelot PK-S suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications: Shoulder: -Bankart repair - -SLAP lesion repair - -Acromioclavicular separation repair - -Rotator cuff repair - -Capsular shift or capsulolabral reconstruction - -Biceps tenodesis - -Deltoid repair Foot/Ankle: - -Hallux Valgus reconstruction - -Medial stabilization - -Lateral stabilization - -Achilles tendon repair - -Mid-foot reconstruction - -Metatarsal ligament/ tendon repair - -Bunionectorny Elbow: - -Ulnar/ radial collateral ligament reconstruction -Biceps tendon reattachment - -Lateral epicondylitis repair Hand/Wrist: - -Scapholunate ligament reconstruction - -Ulnar/Radial collateral ligament reconstruction Knee: - -Medial collateral ligament repair - -Lateral collateral ligament repair - -Posterior oblique ligament repair - -Iliotibial band tenodesis - -Patellar tendon repairs - -Anterior cruciate ligament repair (4.75-5.5mm anchors only) - -Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5mm anchors only) -Quadriceps tendon repair (4.75 mm anchors only) -Meniscal root repair (4.75 mm anchors only) Hip: -Capsular Repair -Acetabular labral repair - -Proximal hamstring repair (4.75-5.5mm anchors only) - -Gluteus Medius Repair (4.75-5.5mm anchors only)
The Javelot PK-P suture anchor is intended for the reattachment of soft tissue to bone for the following indications: Shoulder: - -Rotator cuff repair -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 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 Javelot PK-P suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications: - Shoulder: -Bankart repair - -SLAP lesion repair - -Acromioclavicular separation repair - -Rotator cuff repair - -Capsular shift or capsulolabral reconstruction - -Biceps tenodesis - -Deltoid repair - Foot/ Ankle: -Hallux Valgus reconstruction -Medial stabilization -Lateral stabilization -Achilles Tendon Repair -Mid-foot reconstruction -Metatarsal ligament repair/ tendon repair -Digital tendon transfers (2.5mm anchor only) -Bunionectomy (2.9-4.5mm anchors only) Elbow: -Ulnar or radial collateral ligament reconstructions -Biceps tendon reattachment - -Lateral epicondylitis repair (2.9-4.5mm anchors only) Hand/ Wrist: -Scapholunate ligament reconstruction -Ulnar collateral ligament reconstruction (2.9-4.5mm anchors only) -Radial collateral ligament reconstruction (2.9-4.5mm anchors only) -Carpal ligament reconstruction (2.5mm anchors only) -Repair/Reconstruction of collateral ligaments (2.5mm anchors only) -Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits (2.5mm anchors only) -Digital tendon transfers (2.5mm anchors only) Knee: -Medial collateral ligament repair -Lateral collateral ligament repair -Posterior oblique ligament repair -Iliotibial band tenodesis -Patellar tendon repairs Hip: (2.9-4.5mm anchors only) -Acetabular labral repair -Capsular repair
The Javelot PK-L suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications: - Shoulder: - -Bankart lesion repair - -SLAP lesion repair - -Acromioclavicular separation repair - -Rotator cuff tear repair - -Capsular shift or capsulolabral reconstruction - -Biceps tenodesis - -Deltoid repair - -Anterior shoulder instability (3.7mm anchors only) Foot/ Ankle: - -Hallux Valgus repair - -Medial or lateral instability repair - -Midfoot reconstruction - -Metatarsal ligament/tendon repair/reconstruction - -Achilles tendon repair/reconstruction - -Bunionectomy (3.7mm anchors only) Elbow: - -Ulnar or radial collateral ligament reconstruction -Biceps tendon reattachment -Lateral epicondylitis repair (3.7mm anchors only) - Hand/Wrist: - -Scapholunate ligament reconstruction - -Ulnar collateral ligament reconstruction - -Radial collateral ligament reconstruction Knee: - -Medial collateral ligament repair -Lateral collateral ligament repair -Posterior oblique ligament repair - -Iliotibial band tenodesis - -Patellar tendon repair Hip: (3.7mm anchors only) -Hip capsule repair Acetabular labrum reattachment/ reconstruction
Device Description
All Javelot PEEK suture anchors are preassembled onto an inserter, which enables insertion of the anchor into bone after creation of a pilot hole. The anchors are offered in a polyetheretherketone (PEEK) material with a screw-in, push-in (with or without lock-in) design. The sutures are offered in non-absorbable USP braid ultrahigh molecular weight polyethylene (UHMWPE) material. The preassembled inserter consists of an insertion rod and an insertion handle, the insertion rod is offered in stainless steel material, the insertion handle is offered in acrylonitrile butadiene Styrene copolymers (ABS) material. Javelot PEEK suture anchors come in various configurations, including: with attached nonabsorbable suture(s). Javelot PEEK suture anchors are non-absorbable, provided sterile, for single use only.
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K Number
K230874Device Name
Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath
Manufacturer
Date Cleared
2023-05-23
(54 days)
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Suzhou Endophix Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Syntheface PEEK Interference Screw is indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9mm or less are also indicated for use in the following procedures: Knee -ACL Repair -PCL Repair -Extra-capsular repair Medial collateral ligament Lateral collateral ligament Posterior oblique ligament -Patellar realignment and tendon repair Vastus medialis obliquus advancement -Iliotibial band tenodesis Shoulder -Capsular stabilization Bankart repair Anterior shoulder instability SLAP lesion repair Capsular shift or capsulolabral reconstruction -Acromioclavicular separation repair -Deltoid repair -Rotator cuff tear repair -Biceps tenodesis Foot and Ankle -Hallux valgus repair -Medial or lateral instability repair/reconstruction -Achilles tendon repair/reconstruction -Midfoot reconstruction -Metatarsal ligament/tendon repairs/reconstruction -Bunionectomy -Flexor Hullucis Longus (FLH) -Tendon Transfer Elbow, Wrist, and Hand -Biceps tendon reattachment -Ulnar or radial collateral ligament reconstruction -Lateral epicondylitis repair -Scapholunate ligament reconstruction -Tendon Transfer -Tendon Transfer -Carpometacarpal Joint Arthroplasty -Carpal Ligament Reconstruction
The Syntheface PEEK Screw Sheath is indicated for use in combination with Syntheface PEEK Interference Screw for fixation of soft tissue to bone during cruciate ligament reconstruction.
Device Description
All Syntheface PEEK Interference Screws are non-absorbable. All interference screws are offered in a polyetheretherketone (PEEK) material. Syntheface PEEK Interference Screws are provided sterile, for single use only. The Syntheface PEEK Interference Screws are composed of 6 different configurations ranging from 6mm to 11mm in diameter and 25mm in length. The Syntheface PEEK Interference Screw can be used alone or be used in conjunction with the Syntheface PEEK Screw Sheath. The Syntheface PEEK Screw Sheath shall be used in conjunction with the Syntheface PEEK Interference Screw. All Syntheface PEEK Screw Sheaths are non-absorbable, and are intra-tunnel devices used to secure soft tissue grafts to bone during cruciate ligament reconstruction procedures. The Syntheface PEEK Screw Sheath is a polyetheretherketone (PEEK) material implant for use with Syntheface PEEK Interference Screw. Syntheface PEEK Screw Sheaths are provided sterile, for single use only.
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