# K151220: Dunamis Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Dunamis, LLC
- Decided: Oct 14, 2015 after 160 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). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083635: Smith & Nephew Biosure PK Interference Screw, Smith & Nephew Endoscopy, Inc. (2009) Summary page 4.

## Indications for use
The Dunamis Interference Screw are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameters of 9mm or less and a length of 25mm or less are also intended for use in the following procedures: Knee • ACL Repairs • PCL Repairs • Extra-capsular repairs ̵ Medial collateral ligament ̵ Lateral collateral ligament ̵ Posterior oblique ligament • Patellar realignment and tendon repairs ̵ Vastus medialis obliquous advancement • Iliotibial band tenodesis Foot and Ankle • Hallux valgus repairs • Medial or lateral instability repairs/reconstructions • Achilles tendon repairs/reconstructions • Midfoot reconstructions • Metatarsal ligament/tendon repairs/reconstructions • Bunionectomy • Flexor Hullucis Longus (FLH) • Tendon Transfers Shoulder • Capsular stabilization ̵ Bankart repair ̵ Anterior shoulder instability ̵ SLAP lesion repairs ̵ Capsular shift or capsulolabral reconstructions • Acromioclavicular separation repairs • Deltoid repairs • Rotator cuff tear repairs • Biceps tenodesis Elbow, Wrist, and Hand • Biceps tendon reattachment • Ulnar or radial collateral ligament reconstructions • Lateral epicondylitis repair • Scapholunate ligament reconstruction • Tendon Transfers • Carpometacarpal Joint Arthroplasty • Carpal Ligament Reconstruction

Source page: https://510kreport.com/device/K151220
Methodology: https://510kreport.com/methodology