# K113084: Renovis Cannulated Screw System

- Pathway: 510(k) (Special)
- Applicant: Renovis Surgical Technologies, LLC
- Decided: Dec 9, 2011 after 52 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 1 generation back to K092082 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092082: Synergy Cannulated Screw System, Synergy Surgical Technologies, LLC (2009) Summary page 1.

## Indications for use
The Renovis Cannulated Screw System is intended for long and small bone fracture fixation, including: fractures of the tarsals and metatarsals; metatarsal and phalangeal osteotomnies; fractures of the carpals and metacarpals; carpal and metacarpal arthrodesis; small fragments of the hand and wrist; ligament fixation as appropriate; sacroiliac joint disruptions; fractures of the distal Femur and proximal tibia; intracapsular fractures of the hip; ankle arthrodesis;- and pelvis and acetabulurn fractures. T'his system is not indicated for use in the spine.

Source page: https://510kreport.com/device/K113084
Methodology: https://510kreport.com/methodology