# K160996: Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm

- Pathway: 510(k) (Traditional)
- Applicant: Dunamis, LLC
- Decided: Jul 6, 2016 after 89 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). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082215: Osteoraptor Suture Anchor, Smith & Nephew Inc., Endoscopy Division (2008) Summary page 4.
- K072785: Twinfix FT PK, Smith & Nephew Inc., Endoscopy Division (2007) Summary page 4.

## Most influential descendants
- K193245: Dunamis PunchTac Suture Anchors (2020), 0 descendants of its own

## Indications for use
The Dunamis Suture Anchor suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder Elbow, Wrist, and Hand Capsular Stabilization Ulnar or radial collateral ligament reconstructions - Bankart Repair Lateral epicondylitis repair - Anterior Shoulder Instability Biceps tendon reattachment - SLAP lesion repairs - Capsular Shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid Repairs Rotator Cuff tear repairs Biceps tenodesis Knee Extra-capsular repairs: - medial collateral ligament - lateral collateral ligament - posterior oblique ligament Patellar realignment and tendon repairs: Foot and Ankle - vastus medialis obliquous advancement Hallux vaigus repairs lliotibial band tenodesis Medial or lateral instablility repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairsi/reconstructions Bunionectomy

Source page: https://510kreport.com/device/K160996
Methodology: https://510kreport.com/methodology