# K212381: VersaTap, VersaLat, DueLock, VersaTi, MiniTi - Pathway: 510(k) (Traditional) - Applicant: Ortho-Design (Pty), Ltd. - Decided: Dec 6, 2021 after 126 days - Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue) - Device class: 2 - Regulation: 21 CFR 888.3040 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 12 generations back to K911837 (1991). 188 ancestors in all. 1 later device descends from it; 1 cites it directly. 0 of 190 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K120942: Parcus Twist 4 5MM Peek Suture Anchor, Parcus Twist 5.5MM Peek Suture Anchor & Parcus Triple Twist 5.5MM Peek Suture Anc, Parcus Medical, LLC (2012) Summary page 5. - K061665: Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT, Arthrex, Inc. (2006) Summary page 5. - K173788: Arthrex Corkscrew FT, Arthrex, Inc. (2018) Summary page 5. - K130917: Healix Advance Knotless BR Anchor, Depuy Mitek, A Johnson & Johnson Company (2013) Summary page 8. - K190728: Arthrex SwiveLock Anchors, Arthrex, Inc. (2019) Summary page 8. - K203495: Arthrex SwiveLock Anchor, Arthrex, Inc. (2021) Summary page 8. - K201786: Arthrex Mini Hip PushLock, Arthrex, Inc. (2020) Summary page 10. - K101679: Arthrex Pushlock Anchors, Arthrex, Inc. (2010) Summary page 10. - K193295: Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor, Parcus Medical, LLC (2020) Summary page 10. - K121018: Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an, Smith & Nephew, Inc. (2012) Summary page 10. - K050358: Artherx Corkscrew FT II Suture Anchor, Arthrex, Inc. (2005) Summary page 13. - K201083: Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors, Parcus Medical, LLC (2020) Summary page 13. - K071257: Mini Quickanchor and Quickanchor Plus with Orthocord, Depuy Mitek, A Johnson & Johnson Company (2007) Summary page 16. - K111000: Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture Anchor, Parcus Medical, LLC (2011) Summary page 16. - (no number) Rejoin Medical 2mm Ti Anchor: named in the summary without a submission number ## Most influential descendants - K242296: VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK) (2024), 0 descendants of its own ## Indications for use The VersaTapT ' Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaTap TM Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Elbow: Tennis elbow repair Knee: Medial and lateral collateral ligament repair. Wrist: Scapholunate ligament reconstruction The VersaLatTM Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: Shoulder: Rotator Cuff Repair, Biceps Tenodesis Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Iliotibial Band Tenodesis The DueLockTM Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The DueLockTM Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Capsular Shift and Capsulolabral Reconstruction, Subscapularis Tendon Tears Elbow: Ulnar/Radial Collateral Ligament Reconstruction, and Lateral Epicondylitis repair Foot/Ankle: Lateral Stabilization, Medial Stabilization, Mid-foot Reconstruction, Hallux Valgus Reconstruction, Metatarsal Ligament Repair, Metatarsal Tendon Repair. Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction. Hip: Acetabular labral repair. The VersaTiTM Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Elbow: Tennis elbow repair Knee: Medial and lateral collateral ligament repair, Joint capsule closure Wrist: Scapholunate ligament reconstruction Hip: Capsular Repair, acetabular labral repair The MiniTi~m Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The MiniTiTM Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: Elbow: Ulnar/Medial Collateral Ligament Repair Foot/Ankle: Achilles Tendon Repair, Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-foot Reconstruction, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction. Source page: https://510kreport.com/device/K212381 Methodology: https://510kreport.com/methodology