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510(k) Data Aggregation
K Number
K193108Device Name
Bonecam Suture Anchor
Manufacturer
Valeris Medical Inc.
Date Cleared
2020-03-26
(139 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Valeris Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Shoulder
- Rotator Cuff Repair
- · Bankart Repair
- · SLAP Lesion Repair
- · Biceps Tenodesis
- · Acormio-Clavicular Separation Repair
- · Deltoid Repair
- Capsular Shift or Capsulolabral Reconstruction
Hand and 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
Foot and 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
- Posterior oblique ligament repair
- Illiotibial band tenodesis reconstruction
- Patellar ligament/tendon repair
Device Description
The BoneCam Suture Anchor Delivery Systems are for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The BoneCam Suture Anchor Delivery System consists of a single anchor with integrated multiple suture attachment. The anchors are provided loaded on individual inserters with integrated sutures with or without needles, sterile (EtO), for single use only. The BoneCam Suture Anchor Delivery Systems have a shelf life of 2 years. Implants are fabricated from Solvay Zeniva ZA-500, ZA-600, or ZA-600 CF30 PEEK (ASTM F2026).
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K Number
K192810Device Name
Apollo Suture Anchor System
Manufacturer
Valeris Medical
Date Cleared
2020-03-11
(162 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Valeris Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Apollo Medial, Medial with Needles, and Apollo XT Suture Anchor:
Shoulder
- · Rotator Cuff Repair
- · Bankart Repair
- · SLAP Lesion Repair
- · Biceps Tenodesis
- · Acromio-Clavicular Separation Repair
- · Deltoid Repair
- · Capisular Shift or Capsulolabral Reconstruction
Foot/Ankle
- · Lateral Stabilization
- · Medial Stabilization
- · Achilles Tendon Repair
Knee
- · Medial Collateral Ligament Repair
- · Lateral Collateral Ligament Repair
- · Posterior Oblique Ligament Repair
- · Illiotibial Band Tenodesis
Elbow
- · Biceps Tendon Reattachment
- · Ulnar or Radial Collateral Ligament Reconstruction
Hip
- · Capsular Repair
- · Acetabular Labral Repair
Apollo Knotless Anchor:
Shoulder
- · Rotator Cuff Repair
- · Bankart Repair
- · SLAP Lesion Repair
- · Biceps Tenodesis
- · Acromio-Clavicular Separation Repair
- · Deltoid Repair
- · Capisular Shift or Capsulolabral Reconstruction
Wrist/Hand
- · Scapholunate Ligament Reconstruction
- · Ulnar/Radial Collament Reconstruction
Foot/Ankle
- · Lateral Stabilization
- · Medial Stabilization
- · Achilles Tendon Repair/Reconstruction
- · Hallux Valgus Reconstruction
- · Mid- and Forefoot Reconstruction
Elbow
- · Biceps Tendon Reconstruction
- · Ulnar or Radial Collateral Ligament Reconstruction
- · Lateral Epicondylitis Repair (PEEK Anchor Only)
Knee
- · Medial Collateral Ligament Repair
- · Lateral Collateral Ligament Repair
- · Posterior Oblique Ligament Repair
- · Joint Capsule Closure
- · Iliotibial Band Tenodesis
- · Patellar Ligament/Tendon Repair
Device Description
The Apollo Medial Suture Anchor, Medial with Needles, XT Suture Anchor, Knotless Anchor Delivery Systems are delivery systems for anchors for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. These anchors consist of cannulated anchors with integrated suture attachment or separate suture punch eyelet. The Anchors are provided loaded on individual inserters with and without integrated sutures, sterile, for single use only. Implants are fabricated from Solvay Zeniva ZA-500, ZA-600, or ZA-600 CF30 PEEK (ASTM F2026).
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K Number
K152255Device Name
BoneCam Suture Anchors
Manufacturer
VALERIS MEDICAL
Date Cleared
2015-11-16
(98 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
VALERIS MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Valeris BoneCam Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.
Shoulder Rotator Cuff Repair Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acormio-Clavicular Separation Repair Deltoid Repair Capisular 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 Posterior Oblique Ligament Repair Iliotibial Band Tenodesis Reconstruction Patellar Ligament/Tendon Repair
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
Device Description
The BoneCam Suture Anchor Delivery Systems are delivery systems for anchors for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, hip, and hand/wrist procedures. These anchors consist of anchors with integrated suture attachment. The Anchors are provided loaded on individual inserters with integrated UHMWPE sutures. Sterile, for single use only. Anchor implants are made from either a titanium alloy (6AI4V ELI) per ASTM F136, or PEEK (Zeniva ZA-500) per ASTM F2026 from Solvay Advanced Polymers. Anchors range in size from 2.9mm to 3.3mm in diameter and 6mm to 10mm in length.
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K Number
K142230Device Name
Apollo Suture Anchor System and Titan Screws
Manufacturer
Valeris Medical
Date Cleared
2014-09-10
(28 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Valeris Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Apollo Suture Anchors and Titan Screws are indicated for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The screws are intended for use in the following procedures:
Indications - Apollo Medial Suture Anchor and Apollo XT Suture Anchors: 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 Collateral Ligament Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis), Elbow (Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction), Hip (Capsular Repair, Acetabular Labral Repair).
Indications - Apollo Labral Suture Anchor: Shoulder (Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction), Wrist (Scapholunate Ligament Reconstruction), Elbow (Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction), Hip (Capsular Repair, Acetabular Labral Repair), Knee (Extracapsular Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Joint Capsule Closure, Iliotibial Band Tenodesis Reconstruction, Patellar Ligament/Tendon Repair, Vastus Medialis Obliquus Muscle Advancement).
Indications - Apollo Lateral Anchor: Shoulder (Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction), Wrist/Hand (Scapholunate Ligament Reconstruction, Ulnar/Radial Collateral Ligament Reconstruction), Foot/Ankle (Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair/Reconstruction, Hallux Valgus Reconstruction, Mid and Forefoot Reconstruction), Elbow (Biceps Tendon Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair (PEEK Anchor Only)), Knee (Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Joint Capsule Closure, Iliotibial Band Tenodesis, Patellar Ligament/Tendon Repair).
Indications –Interference Screws: The Titan Interference Screws are 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 9 mm or less and a length of 23 mm or less are also intended for the use in the following procedures: Knee (ACL repairs, PCL repairs, Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis oliquous advancement), Iliotibial band tenodesis), Shoulder (Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift of capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis), Foot and Ankle (Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy, Flexor Hullucis Longus, Tendon transfers), Elbow, Wrist, and Hand (Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Scapholunate ligament reconstruction, Tendon transfers).
Indications –Titan Mini-Interference Screws: The Titan Mini-Interference Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. The Mini-Interference Screws are intended to provide soft tissue reattachment (i.e. fixation of ligament and tendon graft tissue). See below for specific indications. Shoulder (Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift of capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis), Foot and Ankle (Hallux valgus reconstruction, Medial stabilization, Lateral stabilization, Achilles Tendon Repair, Midfoot reconstructions, Metatarsal ligament repair, Bunionectomy, Flexor Hullucis Longus for Achilles Tendon reconstruction, Tendon transfers in the foot and ankle), Knee (Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, Posterior Cruciate Ligament Repair), Elbow (Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction), Wrist and Hand (Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometalcarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, Tendon transfer in the hand/wrist, Lateral Epicondylitis repair).
Device Description
Apollo Family: The Apollo Medial Suture Anchor, XT Suture Anchor, Lateral Anchor, and Labral Suture Anchor are delivery systems for anchors for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. These anchors consist of cannulated anchors with integrated suture attachment or separate suture punch eyelet. The Anchors are provided loaded on individual inserters with and without integrated sutures, sterile, for single use only.
Titan Family: The Titan Interference and Mini-Interference Screws are interference screws for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The screws are provided sterile, for single use only.
Screw and anchor implants are made from either a titanium alloy (6AI4V) per ASTM F136, or PEEK (Zeniva ZA-500) per ASTM F2026 from Solvay Advanced Polymers.
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