510(k) · Cleared
ClearedNovoGen Wound Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novabone Products, LLC · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Jun 9, 2023 as substantially equivalent to K092096 (Mesynthes, Ltd., 2010) and 1 other predicate after a 472-day review. Its family tree reaches back 8 generations to 1996. 1 later device descends from it.
- Decided
- Jun 9, 2023
- Review
- 472 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K960978 (1996). 61 ancestors in all, the oldest K830889 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 7 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 6 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 5 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 4 generations backK080009 Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008
- 3 generations backK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
- 2 generations backK101860 Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010
- 1 generation backK110368 Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- This deviceK220498 NovoGen Wound MatrixNovabone Products, LLC · 2023
- Descendant · cites it directly · 0 of its ownK260711 Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus…Berkeley Advanced Biomaterials · 2026
Most influential descendants
Showing 1 of 1 · See all- K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −7 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −6 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −5 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −4 | K080009 | Novabone Putty- Bioactive Synthetic Graft | Novabone Products, LLC | 2008 | — |
| −3 | K082672 | Novabone Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2008 | — |
| −2 | K101860 | Novabone Putty- Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2010 | — |
| −1 | K110368 | Novabone Putty - Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2011 | — |
| 0 (this device) | K220498 | NovoGen Wound Matrix | Novabone Products, LLC | 2023 | — |
| +1 | K260711 | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix… | Berkeley Advanced Biomaterials | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 7 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K092096 | Endoform Dermal TemplateSummary page 4…Wound Matrix Common Name Collagen Wound Matrix KGN Code – Classification Unclassified Primary Predicate K092096 Mesynthes Endoform Dermal Template K110368 NovaBone Putty - Bioactive Synthetic Bone Graft Reference Devi… | 2010 |
| * | K110368 | Novabone Putty - Bioactive Synthetic Bone GraftSummary page 4…KGN Code – Classification Unclassified Primary Predicate K092096 Mesynthes Endoform Dermal Template K110368 NovaBone Putty - Bioactive Synthetic Bone Graft Reference Devices K112428 NovaBone Dental Morsels - Bioactive Synthetic Bon… | 2011 |
| † | K112428 | Novabone Dental Morsels - Bioactive Synthetic Bone Graft | 2011 |
| † | K141207 | Novabone Bioactive Strip | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260711 | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc… | 2026 | 0 |
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 27 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 61 ancestors have a recall of any class.
- Of its descendants, K260711 (Berkeley Advanced Biomaterials, 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K092096.
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. 2023, 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?
NovoGen Wound Matrix is indicated for the 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, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
• Trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears)
• Draining wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220498: NovoGen 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/K220498
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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