# K193245: Dunamis PunchTac Suture Anchors

- Pathway: 510(k) (Special)
- Applicant: Dunamis, LLC
- Decided: Feb 14, 2020 after 81 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: 9 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)
- K160996: Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm, Dunamis, LLC (2016) Summary page 6.
- K082215: Osteoraptor Suture Anchor, Smith & Nephew Inc., Endoscopy Division (2008) Summary page 6.
- K112526: Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, Smith & Nephew, Inc. (2012) Summary page 6.

## Indications for use
The Dunamis PunchTac Suture Anchors are intended to be used for reattachment of soft tissue to bone for the following indications: Shoulder Capsular stabilization Bankart repair Anterior shoulder instability repair SLAP lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis Elbow Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Foot and Ankle Hallux valgus repairs Medial or lateral instability repairs/ reconstructions Achilles tendon repairs/ reconstructions Midfoot reconstructions Metatarsal ligament/ tendon repairs/ reconstructions Bunionectomy Knee Extra-capsular repairs: medial collateral ligament, lateral collateral ligament, posterior oblique ligament Patellar realignment and tendon repairs: vastus medialis obliquous advancement, Iliotibial band tenodesis Hip Hip capsule repair Acetabular labrum reattachment Abductor tendon repair (in anchors 4.5mm-6.5mm)

Source page: https://510kreport.com/device/K193245
Methodology: https://510kreport.com/methodology