# K973812: Arthrex Puddu Osteotomy System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jun 10, 1998 after 246 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
No predicates in its family tree.
30 later devices descend from it; 4 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Intermedics bone plates: named in the summary without a submission number

## Most influential descendants
- K033303: Wafer System (2004), 23 descendants of its own
- 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

## Indications for use
The Arthrex Opening Wedge Osteotomy System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial or Distal Femoral opening wedge osteotomies.

Source page: https://510kreport.com/device/K973812
Methodology: https://510kreport.com/methodology