# K230517: Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)

- Pathway: 510(k) (Traditional)
- Applicant: Jarmon Medical, LLC (Dba Legends Orthopedics)
- Decided: Sep 11, 2023 after 196 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: 6 generations back to K961555 (1996). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111590: Rog Suture Anchor, Rog Knotless Suture Anchor, Rog Sports Medicine, Inc. (2011) Summary page 6.

## Indications for use
The Legends Orthopedics 5.5 mm Suture Anchors is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle, and knee. Specific indications are as follows: Shoulder: Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis. Wrist/Hand: Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction. Foot/Ankle: Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions. Elbow: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair. Knee: a Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure. The Legends Orthopedics 2.9 mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows: Shoulder: Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis. Wrist/Hand: Scapholunate ligament reconstruction. Elbow: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction. Knee: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement. The Legends Orthopedics 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows: Shoulder indications: - Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis. Wrist/Hand indications: - Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction. Foot/Ankle indications: - Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions. Elbow indications: - Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair. Knee indications: - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.

Source page: https://510kreport.com/device/K230517
Methodology: https://510kreport.com/methodology