510(k) · Cleared
ClearedNeoMatriX Wound Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nextgen Biologics, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Oct 7, 2021 as substantially equivalent to K181330 (Nextgen Biologics, Inc., 2018) after a 276-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Oct 7, 2021
- Review
- 276 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K921895 (1992). 29 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 10 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 6 generations between
- 3 generations backK112409 Matristem Wound MatrixAcell, Inc. · 2011
- 2 generations backK152721 Cytal Wound MatrixAcell, Inc. · 2015 · Recalled
- 1 generation backK181330 NeoMatriX Wound MatrixNextgen Biologics, Inc. · 2018
- This deviceK210024 NeoMatriX Wound MatrixNextgen Biologics, Inc. · 2021
Show all 10 generations
- Root · 10 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 9 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 8 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 7 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 6 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 5 generations backK021637 Acell Ubm Lyophilized Wound DressingAcell, Inc. · 2002
- 4 generations backK092926 Acell Matristem Wound SheetAcell, Inc. · 2009
- 3 generations backK112409 Matristem Wound MatrixAcell, Inc. · 2011
- 2 generations backK152721 Cytal Wound MatrixAcell, Inc. · 2015 · Recalled
- 1 generation backK181330 NeoMatriX Wound MatrixNextgen Biologics, Inc. · 2018
- This deviceK210024 NeoMatriX Wound MatrixNextgen Biologics, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −9 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −8 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −7 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −6 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −5 | K021637 | Acell Ubm Lyophilized Wound Dressing | Acell, Inc. | 2002 | — |
| −4 | K092926 | Acell Matristem Wound Sheet | Acell, Inc. | 2009 | — |
| −3 | K112409 | Matristem Wound Matrix | Acell, Inc. | 2011 | — |
| −2 | K152721 | Cytal Wound Matrix | Acell, Inc. | 2015 | 5 |
| −1 | K181330 | NeoMatriX Wound Matrix | Nextgen Biologics, Inc. | 2018 | — |
| 0 (this device) | K210024 | NeoMatriX Wound Matrix | Nextgen Biologics, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 2000 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K181330 | NeoMatriX Wound MatrixSummary page 4…me: Collagen Wound Dressing Classification Name: Collagen Wound Dressing Regulatory Class: Unclassified Product Code: KGN Predicate Devices: NeoMatriX® Wound Matrix (K181330) Device Description NeoMatriX Wound Matrix is a sterile, wound dressing fabricated from the dermal extracellular matrix of axol… | 2018 |
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 2.8 years on median.
- 2 of the 29 ancestors have a recall of any class.
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. 2021, 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?
NeoMatriX® Wound Matrix is intended for management of wounds including:
• Partial and full-thickness wounds,
• Pressure ulcers,
• Venous ulcers,
• Diabetic ulcers,
• Chronic vascular ulcers,
• Tunneled/undermined wounds,
• Surgical wounds (donor sites/grafts, Moh’s surgery, post-laser surgery, podiatric, and wound dehiscience),
• Trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears),
• Draining wounds.
The device is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210024: NeoMatriX Wound Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210024
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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