510(k) · Cleared
Recalled · Class II · 2023Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tei Biosciences, Inc. · FRO Dressing, Wound, Drug
Cleared on Dec 10, 2010 as substantially equivalent to K083440 (Tei Biosciences, Inc., 2008) and 3 other predicates after a 316-day review. Its family tree reaches back 6 generations to 1988. 6 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 10, 2010
- Review
- 316 days
- Class
- Class U
- Product code
- FRO
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 6 generations to K881854 (1988). 15 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 5 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 4 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 3 generations backK023778 DressskinTei Biosciences, Inc. · 2003
- 2 generations backK061407 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2006
- 1 generation backK083440 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2008
- This deviceK100261 Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK120605 Permacol Surgical ImplantCovidien, LLC · 2012
- Descendant · 2 generations on · 1 of its ownK160181 Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC · 2016
- Descendant · 2 generations on · 1 of its ownK133011 Diaphragmatic Hernia GraftCook Biotech, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK171817 Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK172318 Endoform Silver Dermal TemplateAroa Biosurgery · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K120605Permacol Surgical ImplantCovidien, LLC · 2012 · cites it directly4descendants
- K160181Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC · 2016 · 2 generations on1descendant
- K133011Diaphragmatic Hernia GraftCook Biotech, Inc. · 2014 · 2 generations on1descendant
- K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated · 2018 · 3 generations on0descendants
- K172318Endoform Silver Dermal TemplateAroa Biosurgery · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −5 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −4 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −3 | K023778 | Dressskin | Tei Biosciences, Inc. | 2003 | — |
| −2 | K061407 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2006 | — |
| −1 | K083440 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2008 | — |
| 0 (this device) | K100261 | Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold | Tei Biosciences, Inc. | 2010 | — |
| +1 | K120605 | Permacol Surgical Implant | Covidien, LLC | 2012 | — |
| +2 | K160181 | Colorado Therapeutics Xenograft Implant | Colorado Therapeutics, LLC | 2016 | — |
| +2 | K133011 | Diaphragmatic Hernia Graft | Cook Biotech, Inc. | 2014 | 1 |
| +3 | K171817 | Biodesign Diaphragmatic Hernia Graft | Cook Biotech Incorporated | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 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? (4)
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 |
|---|---|---|---|
| * | K083440 | Primatrix Dermal Repair ScaffoldSummary page 1…and intended use to: Predicate Devices Manufacturer 510(k) Numberj PriMatrix TEI Biosciences K083440 DressSki6 TEl Biosciences K023778 ColActive Ag Covalon Technologies… | 2008 |
| * | K023778 | DressskinSummary page 1…510(k) Numberj PriMatrix TEI Biosciences K083440 DressSki6 TEl Biosciences K023778 ColActive Ag Covalon Technologies K043296 Exsalt S07 Exciton Technologies… | 2003 |
| * | K043296 | Colactive AG Collagen with Silver Antimicrobial DressingSummary page 1…es K083440 DressSki6 TEl Biosciences K023778 ColActive Ag Covalon Technologies K043296 Exsalt S07 Exciton Technologies K083870 Summary of Technological Characteristic… | 2005 |
| * | K083870 | Exsalt SD7 Wound DressingSummary page 1…es K023778 ColActive Ag Covalon Technologies K043296 Exsalt S07 Exciton Technologies K083870 Summary of Technological Characteristics and Biocompatibility PriMatrix Ag Antimicrobial is substantially equ… | 2009 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2023 | Class II | Z-2082-2023 | Under Investigation by firm | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Class II | Z-2081-2023 | Under Investigation by firm | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Class II | Z-2080-2023 | Under Investigation by firm | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K120605 (Covidien, LLC, 2012) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K083440.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
PriMatrix Ag Antimicrobial is intended for the management of wounds that include:
* Partial and full thickness wounds
* Pressure, diabetic, and venous ulcers
* Second-degree burns
* Surgical wounds-donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence
* Trauma wounds-abrasions, lacerations, and skin tears
* Tunneled/undermined wounds
* Draining wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100261: Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100261
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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