# K110229: Rog Suture Anchor 5.5MM, 2.9MM

- Pathway: 510(k) (Traditional)
- Applicant: Rog Sports Medicine, Inc.
- Decided: May 18, 2011 after 112 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: 4 generations back to K961555 (1996). 11 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071481: Healix Anchor, Depuy Mitek, A Johnson & Johnson Company (2007) Summary page 1.
- K060693: Microstrike and Allthread Peek Suture Anchor, Arthrotek, Inc. (2006) Summary page 1.
- K061863: Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family, Arthrex, Inc. (2006) Summary page 1.

## Most influential descendants
- K111590: Rog Suture Anchor, Rog Knotless Suture Anchor (2011), 5 descendants of its own
- K113299: Rog Suture Anchor (2011), 2 descendants of its own
- K112991: Modified Rog Suture Anchor (2011), 1 descendant of its own
- 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) (2023), 0 descendants of its own
- K192949: Flower Suture Anchor Set (2020), 0 descendants of its own

## Indications for use
The RoG 5.5 mm 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. The RoG 2.9mm Suture Anchor is indicated for use in soft tissue reattachment procedures. 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. * 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.

Source page: https://510kreport.com/device/K110229
Methodology: https://510kreport.com/methodology