# K082810: Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak and Bio-Composite Corkscrew

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jan 23, 2009 after 121 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K961555 (1996). 6 ancestors in all.
159 later devices descend from it; 13 cite it directly.
0 of 166 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071177: Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak, Bio-Composite Corkscrew, Arthrex, Inc. (2007) Summary page 1.

## Most influential descendants
- K101823: Arthrex Swivelock Anchors (2011), 103 descendants of its own
- K101679: Arthrex Pushlock Anchors (2010), 41 descendants of its own
- K110545: Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK) (2011), 40 descendants of its own
- K151342: Arthrex SwiveLock Anchors (2016), 38 descendants of its own
- K171141: Arthrex SwiveLock Anchors (2017), 29 descendants of its own

## Indications for use
The Arthrex Bio-Composite PushLockTm is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, lup, and pelvis in the following procedures Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle Lateral Stabtization, Medial Stabiliation, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bumonectomy Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Obhque Ligament Repair, lhotibial Band Tenodesis HandlWrts Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Elbow. Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair Pe/s- Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency Hip, Capsular Repair, acetabular labral repair The Arthrex Bio-Composite Corkscrew is intended for fixation of suture (soft issue) to bone in the shoulder, foot/anilde, hip, knee, hand/wrist, elbow, and pelvis in,but not lmiuted to, the following procedures Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabihzation, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repar/Tendon Repair, Bunionectomy Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Ihotibial Band Tenodesis Hand/Wrst Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment; Tennus Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondyhtis Repair Pelvi: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency Hqp: Capsular Repair, acetabular labral repair The Arthrex Bio-Composite TakTm is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, shoulder, elbow, and m select maxillofacial apphcations Specific indications are listed below and are size appropriate per patient needs Skull: Stabilization and fixation of oral cramo-maxillofacial skeletal bone, mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift; Temporomandibular Joint (CMi) reconstruction, Soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and penoorbital bones of the skull Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acrormo-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Hand/Wrst 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, Ihotibial Band Tenodesis Pelvt: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency Hip: Capsular Repair, acetabular labral repair

Source page: https://510kreport.com/device/K082810
Methodology: https://510kreport.com/methodology