# K191961: OrthoGold

- Pathway: 510(k) (Traditional)
- Applicant: Tissue Regeneration Technologies
- Decided: Nov 26, 2019 after 126 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: 1 generation back to DEN160037 (2017). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160037: dermaPACE System, Sanuwave, Inc. (2017) Summary page 4.

## Most influential descendants
- K200926: OrthoGold 100 (2020), 2 descendants of its own
- K231710: OW100S (2023), 1 descendant of its own
- K202112: Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece (2021), 1 descendant of its own
- K243279: DOLORCLAST Focused Shock Waves (2025), 0 descendants 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 chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OrthoGold 100 is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.

Source page: https://510kreport.com/device/K191961
Methodology: https://510kreport.com/methodology