510(k) · Cleared
ClearedOrthoGold 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tissue Regeneration Technologies, LLC · PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Cleared on Aug 28, 2020 as substantially equivalent to K191961 (Tissue Regeneration Technologies, 2019) after a 143-day review. Its family tree reaches back 2 generations to 2017. 2 later devices descend from it.
- Decided
- Aug 28, 2020
- Review
- 143 days
- Class
- Class II
- Product code
- PZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN160037 (2017). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN160037 dermaPACE SystemSanuwave, Inc. · 2017
- 1 generation backK191961 OrthoGoldTissue Regeneration Technologies · 2019
- This deviceK200926 OrthoGold 100Tissue Regeneration Technologies, LLC · 2020
- Descendant · cites it directly · 1 of its ownK231710 OW100SSoftwave/Trt, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK233937 OW100SSoftwave/Trt, LLC · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN160037 | dermaPACE System | Sanuwave, Inc. | 2017 | — |
| −1 | K191961 | OrthoGold | Tissue Regeneration Technologies | 2019 | — |
| 0 (this device) | K200926 | OrthoGold 100 | Tissue Regeneration Technologies, LLC | 2020 | — |
| +1 | K231710 | OW100S | Softwave/Trt, LLC | 2023 | — |
| +2 | K233937 | OW100S | Softwave/Trt, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K191961 | OrthoGoldSummary page 5…reatment of chronic wounds Extracorporeal shock wave device for treatment of chronic wounds 21 CFR 878.4685 PZL Device Name 510(k) Number Procode Class OrthoGold 100™ K191961 PZL II Page 1 of § 0148 K200926 Page 2 of 5 Tissue Regeneration Technologies, LLC Indications for Use The Ort… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231710 | OW100S | 2023 | 1 |
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?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K231710 (Softwave/Trt, LLC, 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K191961.
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. 2020, 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 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).
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/K200926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200926: OrthoGold 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200926
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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