# K200926: OrthoGold 100

- Pathway: 510(k) (Traditional)
- Applicant: Tissue Regeneration Technologies, LLC
- Decided: Aug 28, 2020 after 143 days
- Product code: PZL (Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers)
- Device class: 2
- Regulation: 21 CFR 878.4685
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN160037 (2017). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191961: OrthoGold, Tissue Regeneration Technologies (2019) Summary page 5.

## Most influential descendants
- K231710: OW100S (2023), 1 descendant of its own
- K233937: OW100S (2024), 0 descendants of its own

## Indications for use
The OrthoGold 100™ is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years and older). The OrthoGold 100 is indicated for use in conjunction with standard of care burn treatment(s).

Source page: https://510kreport.com/device/K200926
Methodology: https://510kreport.com/methodology