# 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)

- Pathway: 510(k) (Special)
- Applicant: Ortho-Design (Pty), Ltd.
- Decided: Aug 29, 2024 after 27 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: 13 generations back to K911837 (1991). 189 ancestors in all.
No later device cites it as a predicate yet.
0 of 190 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212381: VersaTap, VersaLat, DueLock, VersaTi, MiniTi, Ortho-Design (Pty), Ltd. (2021) Summary page 5.
- K130917: Healix Advance Knotless BR Anchor, Depuy Mitek, A Johnson & Johnson Company (2013) Summary page 15.

## Indications for use
VersaTap™ Suture Anchor The VersaTap™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaTap™ 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 VersaPEEK™ Suture Anchor The VersaPEEK™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaPEEK™ 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 MicroTi™ Suture Anchor The MicroTi™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The MicroTi™ 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. VersalLat™ Ti Suture Anchor The VersalLat™ Ti 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 lliotibial Band Tenodesis Foot/Ankle: Lateral stabilization, medial stabilization, Achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, metatarsal tendon repair, bunionectomy, and digital tendon transfers. VersalLat™ Suture Anchor The VersalLat™ 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 lliotibial Band Tenodesis. Foot/Ankle: Lateral stabilization, medial stabilization, Achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, metatarsal tendon repair, bunionectomy, and digital tendon transfers.

Source page: https://510kreport.com/device/K242296
Methodology: https://510kreport.com/methodology