# K160500: Elite SPK, Compasso, Elite SPK Kit

- Pathway: 510(k) (Traditional)
- Applicant: Ncs Lab Srl
- Decided: Apr 20, 2016 after 57 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: 11 generations back to K911837 (1991). 86 ancestors in all.
No later device cites it as a predicate yet.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120356: NCS Fish-Fit MD System Fish-Fit MD Compass MD, Ncs Lab Srl (2012) Summary page 5.

## Indications for use
The implantable device Elite SPK is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tears. It is intended to be implanted using the Compasso surgical instruments. Compasso is a series of surgical instruments intended for use for the implantation of the Elite SPK or the Sharc-FT bone anchor.

Source page: https://510kreport.com/device/K160500
Methodology: https://510kreport.com/methodology