510(k) · Cleared
ClearedOrthoGold
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tissue Regeneration Technologies · PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Cleared on Nov 26, 2019 as substantially equivalent to DEN160037 (Sanuwave, Inc., 2017) after a 126-day review. Its family tree reaches back 1 generation to 2017. 5 later devices descend from it.
- Decided
- Nov 26, 2019
- Review
- 126 days
- Class
- Class II
- Product code
- PZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN160037 (2017). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backDEN160037 dermaPACE SystemSanuwave, Inc. · 2017
- This deviceK191961 OrthoGoldTissue Regeneration Technologies · 2019
- Descendant · cites it directly · 2 of its ownK200926 OrthoGold 100Tissue Regeneration Technologies, LLC · 2020
- Descendant · cites it directly · 1 of its ownK231710 OW100SSoftwave/Trt, LLC · 2023
- Descendant · cites it directly · 1 of its ownK202112 Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia…Storz Medical AG · 2021
- Descendant · 2 generations on · 0 of its ownK243279 DOLORCLAST Focused Shock WavesE.M.S Electro Medical Systems S.A · 2025
- Descendant · 2 generations on · 0 of its ownK233937 OW100SSoftwave/Trt, LLC · 2024
Most influential descendants
Showing 5 of 5 · See all- K200926OrthoGold 100Tissue Regeneration Technologies, LLC · 2020 · cites it directly2descendants
- K231710OW100SSoftwave/Trt, LLC · 2023 · cites it directly1descendant
- K202112Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia HandpieceStorz Medical AG · 2021 · cites it directly1descendant
- K243279DOLORCLAST Focused Shock WavesE.M.S Electro Medical Systems S.A · 2025 · 2 generations on0descendants
- K233937OW100SSoftwave/Trt, LLC · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN160037 | dermaPACE System | Sanuwave, Inc. | 2017 | — |
| 0 (this device) | K191961 | OrthoGold | Tissue Regeneration Technologies | 2019 | — |
| +1 | K200926 | OrthoGold 100 | Tissue Regeneration Technologies, LLC | 2020 | — |
| +1 | K231710 | OW100S | Softwave/Trt, LLC | 2023 | — |
| +1 | K202112 | Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece | Storz Medical AG | 2021 | — |
| +2 | K243279 | DOLORCLAST Focused Shock Waves | E.M.S Electro Medical Systems S.A | 2025 | — |
| +2 | K233937 | OW100S | Softwave/Trt, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PZL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PZL device
- #1 K243279 DOLORCLAST Focused Shock Wavesscore 10.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All PZL devicesPZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PZL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PZL
Too few PZL 510(k)s in any year since 2007 to give a median.
Recalls per year · PZL
No recall names PZL since 2007.
Adverse event reports per year · PZL
No MAUDE report names PZL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191961: OrthoGold.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191961
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026