# K192949: Flower Suture Anchor Set

- Pathway: 510(k) (Traditional)
- Applicant: Flower Orthopedics Corporation
- Decided: Oct 7, 2020 after 355 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: 7 generations back to K961555 (1996). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113299: Rog Suture Anchor, Rog Sports Medicine, Inc. (2011) Summary page 5.
- K061863: Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family, Arthrex, Inc. (2006) Summary page 5.
- K110229: Rog Suture Anchor 5.5MM, 2.9MM, Rog Sports Medicine, Inc. (2011) Summary page 5.
- K110230: Rog Knotless Suture Anchor, Rog Sports Medicine, Inc. (2011) Summary page 5.
- K111590: Rog Suture Anchor, Rog Knotless Suture Anchor, Rog Sports Medicine, Inc. (2011) Summary page 5.
- K112991: Modified Rog Suture Anchor, Rog Sports Medicine, Inc. (2011) Summary page 5.

## Indications for use
The Flower Suture Anchor Set is intended to be used to aid arthroscopic and orthopedic reconstructive procedures needing soft tissue fixation, due to injury or degenerative disease. The FlowerAnchor, 3.0mm is indicated for use in 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: Scapholunate ligament reconstruction. • Foot/Ankle indications: Tendon repair/reconstruction, hallux valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions. • Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction. • Knee indications: 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 FlowerAnchor, 5.0mm and FlowerAnchor, Knotless 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, hallux 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/K192949
Methodology: https://510kreport.com/methodology