510(k) · Cleared
Recalled · Class II · 2023PriMatrix Dermal Repair Scaffold
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tei Biosciences, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Feb 22, 2016 as substantially equivalent to K131286 (Tei Biosciences, Inc., 2013) after a 61-day review. Its family tree reaches back 7 generations to 1988. 4 later devices descend from it. It has been recalled 4 times.
- Decided
- Feb 22, 2016
- Review
- 61 days
- Class
- Class U
- Product code
- KGN
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 7 generations to K881854 (1988). 13 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- 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 backK131286 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2013
- This deviceK153690 PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK201577 MatriDermMedskin Solutions Dr. Suwelack AG · 2021
- Descendant · 2 generations on · 0 of its ownK261224 MatriDermMedskin Solutions Dr. Suwelack AG · 2026
- Descendant · 2 generations on · 0 of its ownK250864 MatriDerm pluS+ Bi-LayerMedskin Solutions Dr. Suwelack AG · 2025
- Descendant · cites it directly · 0 of its ownK250397 Helios Dermal ScaffoldHelios Biomedical, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K201577MatriDermMedskin Solutions Dr. Suwelack AG · 2021 · cites it directly2descendants
- K261224MatriDermMedskin Solutions Dr. Suwelack AG · 2026 · 2 generations on0descendants
- K250864MatriDerm pluS+ Bi-LayerMedskin Solutions Dr. Suwelack AG · 2025 · 2 generations on0descendants
- K250397Helios Dermal ScaffoldHelios Biomedical, Inc. · 2025 · cites it directly0descendants
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 | K131286 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2013 | — |
| 0 (this device) | K153690 | PriMatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2016 | — |
| +1 | K201577 | MatriDerm | Medskin Solutions Dr. Suwelack AG | 2021 | — |
| +2 | K261224 | MatriDerm | Medskin Solutions Dr. Suwelack AG | 2026 | — |
| +2 | K250864 | MatriDerm pluS+ Bi-Layer | Medskin Solutions Dr. Suwelack AG | 2025 | — |
| +1 | K250397 | Helios Dermal Scaffold | Helios Biomedical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 KGN? 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 KGN device
- #1 K231325 Corplex P / Theracor P / Allacor Pscore 17.9 · 8 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 |
|---|---|---|---|
| * | K131286 | Primatrix Dermal Repair ScaffoldSummary page 4…cation: Unclassified Product Code: KGN Predicate Device: PriMatrix™ Dermal Repair Scaffold 510(k) No. K131286; Product Code: KGN Device Intended Use: PriMatrix is intended for… | 2013 |
What descends from it? (4)
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-2078-2023 | 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-2077-2023 | 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-2079-2023 | Under Investigation by firm | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| Jun 15, 2017 | Class II | Z-0383-2018 | Error in labeling | During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (IFUs) from Lot RM1608011 Part 520-002v10 contained extra pages and/or missing pages: " 22 IFUs contained duplicate pages 15 - 26 & 51 - 62… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K201577 (Medskin Solutions Dr. Suwelack AG, 2021) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KGN devicesKGN Wound Dressing With Animal-Derived Material (S): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · KGN
15so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KGN
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGN
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGN
15in 2025
MAUDE reports naming product code KGN, 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 | 3 | 32 | 0 | 0 |
| 2008 | 6 | 87 | 0 | 1 |
| 2009 | 8 | 121 | 0 | 2 |
| 2010 | 4 | 175 | 0 | 3 |
| 2011 | 7 | 228 | 0 | 6 |
| 2012 | 8 | 123 | 0 | 4 |
| 2013 | 6 | 147 | 0 | 6 |
| 2014 | 5 | 188 | 0 | 12 |
| 2015 | 7 | 87 | 0 | 9 |
| 2016 | 4 | 164 | 0 | 6 |
| 2017 | 7 | 136 | 1 | 8 |
| 2018 | 6 | 148 | 3 | 15 |
| 2019 | 3 | 128 | 0 | 11 |
| 2020 | 5 | 279 | 0 | 17 |
| 2021 | 6 | 236 | 0 | 14 |
| 2022 | 12 | 246 | 0 | 13 |
| 2023 | 9 | 194 | 0 | 21 |
| 2024 | 13 | 83 | 0 | 15 |
| 2025 | 10 | 162 | 0 | 15 |
| 2026 | 15 | 174 | 0 | — |
What is it indicated for?
PriMatrix 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-Moh’s 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/K153690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153690: PriMatrix 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/K153690
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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