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 · ISA Massager, Therapeutic, Electric
Cleared on May 5, 2021 as substantially equivalent to K173692 (Storz Medical AG, 2018) after a 78-day review. Its family tree reaches back 15 generations to 1995. 2 later devices descend from it.
- Decided
- May 5, 2021
- Review
- 78 days
- Class
- Class I
- Product code
- ISA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K943450 (1995). 192 ancestors in all, the oldest K800617 (1980). 2 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 2 generations backK112669 Tattoostar Effect YAsclepion Laser Technologies GmbH · 2012
- 1 generation backK173692 D-Actor 200 Vibration Massage SystemStorz Medical AG · 2018
- This deviceK210451 OrthoGold 100Tissue Regeneration Technologies, LLC · 2021
- Descendant · cites it directly · 0 of its ownK210166 Omnispec ED1000Medispec, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK213120 OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt · 2022
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 8 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 7 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 4 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 2 generations backK112669 Tattoostar Effect YAsclepion Laser Technologies GmbH · 2012
- 1 generation backK173692 D-Actor 200 Vibration Massage SystemStorz Medical AG · 2018
- This deviceK210451 OrthoGold 100Tissue Regeneration Technologies, LLC · 2021
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 |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −10 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −9 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −8 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −7 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −4 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −3 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −2 | K112669 | Tattoostar Effect Y | Asclepion Laser Technologies GmbH | 2012 | — |
| −1 | K173692 | D-Actor 200 Vibration Massage System | Storz Medical AG | 2018 | — |
| 0 (this device) | K210451 | OrthoGold 100 | Tissue Regeneration Technologies, LLC | 2021 | — |
| +1 | K210166 | Omnispec ED1000 | Medispec, Ltd. | 2023 | — |
| +1 | K213120 | OW100S (model OW100S-US) | Tissue Regeneration Technologies, LLC Dba AS Softwave Trt | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 5 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 16 | 0 |
| 1997 | 18 | 0 |
| 1998 | 11 | 0 |
| 1999 | 7 | 0 |
| 2000 | 18 | 0 |
| 2001 | 14 | 0 |
| 2002 | 22 | 0 |
| 2003 | 13 | 0 |
| 2004 | 8 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 ISA? 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 ISA device
- #1 K243488 Vmat Proscore 13.0 · 15 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 |
|---|---|---|---|
| * | K173692 | D-Actor 200 Vibration Massage SystemSummary page 5…r, Therapeutic, Electric Regulation Number: 21 CFR 890.5660 Product Codes: ISA Predicate Device: Storz Medical D-Actor 200 Vibration Massage System K173692 Device Description The OrthoGold 100™ is a pulsed acoustic wave device. It includes an electrically powered generator to genera… | 2018 |
What descends from it? (2)
2 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?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 8 of the 192 ancestors have a recall of any class.
- Of its descendants, K210166 (Medispec, Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K173692.
How does its category compare?
All ISA devicesISA Massager, Therapeutic, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · ISA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ISA
Too few ISA 510(k)s in any year since 2007 to give a median.
Recalls per year · ISA
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ISA
16in 2025
MAUDE reports naming product code ISA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 1 | 10 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 1 | 3 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 12 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 2 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 2 | — | 0 | 8 |
| 2023 | 2 | — | 0 | 14 |
| 2024 | 1 | — | 0 | 13 |
| 2025 | 1 | — | 2 | 16 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The OrthoGold 100 is intended for:
Relief of minor muscle aches and pains
Temporary increase in local blood circulation
Activation of connective tissue
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/K210451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210451: 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/K210451
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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