# K033303: Wafer System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Jun 24, 2004 after 254 days
- Product code: HRS (Plate, Fixation, Bone)
- 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: 1 generation back to K973812 (1998). 2 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973812: Arthrex Puddu Osteotomy System, Arthrex, Inc. (1998) Summary page 1.
- K011583: Spiked Washer, Synthes (Usa) (2002)

## Most influential descendants
- K053336: Staxx FX System (2006), 12 descendants of its own
- K063606: Modification to Staxx FX System (2007), 11 descendants of its own
- K132817: Kiva VCF Treatment System (2014), 9 descendants of its own
- K052670: Staxx XD System (2006), 8 descendants of its own
- K090315: Staxx XD System (2009), 6 descendants of its own

## Indications for use
The Wafer System, in conjunction with commercially available supplemental fixation, is intended for use in proximal tibial opening wedge osteotomies as a means to restore anatomical alignment and relative position.

Source page: https://510kreport.com/device/K033303
Methodology: https://510kreport.com/methodology