510(k) · Cleared
ClearedEndoform Silver Dermal Template
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aroa Biosurgery · FRO Dressing, Wound, Drug
Cleared on Nov 17, 2017 as substantially equivalent to K100261 (Tei Biosciences, Inc., 2010) after a 108-day review. Its family tree reaches back 7 generations to 1988.
- Decided
- Nov 17, 2017
- Review
- 108 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K881854 (1988). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 6 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 5 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 4 generations backK023778 DressskinTei Biosciences, Inc. · 2003
- 3 generations backK061407 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2006
- 2 generations backK083440 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2008
- 1 generation backK100261 Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc. · 2010 · Recalled
- This deviceK172318 Endoform Silver Dermal TemplateAroa Biosurgery · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −6 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −5 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −4 | K023778 | Dressskin | Tei Biosciences, Inc. | 2003 | — |
| −3 | K061407 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2006 | — |
| −2 | K083440 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2008 | — |
| −1 | K100261 | Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold | Tei Biosciences, Inc. | 2010 | 3 |
| 0 (this device) | K172318 | Endoform Silver Dermal Template | Aroa Biosurgery | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 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 FRO? 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 FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 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 |
|---|---|---|---|
| * | K100261 | Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldSummary page 4…Dressing, wound, drug Predicate device PriMatrix Ag Antimicrobial Dermal Repair Scaffold (K100261) Reference device Endoform Dermal Template (K092096) Device Description Endoform Silver De… | 2010 |
| † | K092096 | Endoform Dermal Template | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 1 other device also cites its predicate K100261.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, 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 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
Endoform Silver Dermal Template is supplied sterile and is intended for single use in the management of the following wounds:
* partial and full-thickness wounds
* pressure ulcers
* venous ulcers
* diabetic ulcers
* chronic vascular ulcers
* tunnelled / undermined wounds
* surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric,
wound dehiscence)
* trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
* draining wounds
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/K172318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172318: Endoform Silver Dermal Template.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172318
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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