# K013553: Pre-Loaded Ultrafix RC

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Dec 19, 2001 after 55 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: 3 generations back to K921873 (1992). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963812: LM Bone Anchor (Orthopedics), Li Medical Technologies, Inc. (1996) Summary page 2.

## Indications for use
The Pre-Loaded UltraFix® RC is intended to be used for rotator cuff repairs in the shoulder either arthroscopically or in an open technique.

Source page: https://510kreport.com/device/K013553
Methodology: https://510kreport.com/methodology