# K161174: Nanova Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Nanova Biomaterials, Inc.
- Decided: Nov 3, 2016 after 191 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K971358 (1997). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032224: Biorci Screw, Smith & Nephew, Inc. (2003) Summary page 4.
- K060830: Milagro Interference Screw, Depuy Mitek, A Johnson & Johnson Company (2006) Summary page 4.

## Indications for use
Nanova'™ Interference Screw is indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee. The 7, 8 and 9mm x 23mm screws are also indicated for: medial and lateral collateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

Source page: https://510kreport.com/device/K161174
Methodology: https://510kreport.com/methodology