510(k) · Cleared
ClearedSeri Surgical Scaffold
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allergan · OXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Cleared on Apr 25, 2013 as substantially equivalent to K080442 (Serica Technologies, Inc., 2008) and 2 other predicates after a 203-day review. Its family tree reaches back 10 generations to 1992. 5 later devices descend from it.
- Decided
- Apr 25, 2013
- Review
- 203 days
- Class
- Class II
- Product code
- OXF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K921895 (1992). 47 ancestors in all, the oldest K810428 (1981). 5 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 6 generations between
- 3 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 2 generations backK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- 1 generation backK083898 SurgimendTei Biosciences, Inc. · 2009 · Recalled
- This deviceK123128 Seri Surgical ScaffoldAllergan · 2013
- Descendant · cites it directly · 3 of its ownK140533 Galaflex MeshTepha, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK161092 GalaSHAPE 3DTepha, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK202425 SurgiLattice scaffoldTepha, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK172545 SERI ContourSofregen Medical, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK162922 GalaFORM 3DTepha, Inc. · 2017
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 backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 4 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 3 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 2 generations backK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- 1 generation backK083898 SurgimendTei Biosciences, Inc. · 2009 · Recalled
- This deviceK123128 Seri Surgical ScaffoldAllergan · 2013
Most influential descendants
Showing 5 of 5 · See all- K140533Galaflex MeshTepha, Inc. · 2014 · cites it directly3descendants
- K161092GalaSHAPE 3DTepha, Inc. · 2016 · 2 generations on1descendant
- K202425SurgiLattice scaffoldTepha, Inc. · 2021 · 2 generations on0descendants
- K172545SERI ContourSofregen Medical, Inc. · 2017 · cites it directly0descendants
- K162922GalaFORM 3DTepha, Inc. · 2017 · 2 generations on0descendants
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 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −4 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −3 | K051766 | Orthomend | Tei Biosciences, Inc. | 2005 | — |
| −2 | K071807 | Orthomend Soft Tissue Matrix | Tei Biosciences, Inc. | 2007 | 4 |
| −1 | K083898 | Surgimend | Tei Biosciences, Inc. | 2009 | 3 |
| 0 (this device) | K123128 | Seri Surgical Scaffold | Allergan | 2013 | — |
| +1 | K140533 | Galaflex Mesh | Tepha, Inc. | 2014 | — |
| +2 | K161092 | GalaSHAPE 3D | Tepha, Inc. | 2016 | 1 |
| +2 | K202425 | SurgiLattice scaffold | Tepha, Inc. | 2021 | — |
| +1 | K172545 | SERI Contour | Sofregen Medical, Inc. | 2017 | — |
| +2 | K162922 | GalaFORM 3D | Tepha, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2021 | 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 OXF? 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 OXF device
- #1 K232602 3DMatrix Surgical Meshscore 12.8 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K080442 | Seriscaffold Surgical MeshSummary page 1….3300 / General and Plastic Surgery PROCODE: OXF PREDICATE DEVICES: K080442 SERTM Surgical Scaffold K083898 TEl Biosciences SurgiMend Collagen Matrix K810428 Ethicon Vicryl Knitted Mesh DEVICE DESCRIPTION… | 2008 |
| * | K083898 | SurgimendSummary page 1…Surgery PROCODE: OXF PREDICATE DEVICES: K080442 SERTM Surgical Scaffold K083898 TEl Biosciences SurgiMend Collagen Matrix K810428 Ethicon Vicryl Knitted Mesh DEVICE DESCRIPTION: SERITM Surgical Scaffold is a… | 2009 |
| * | K810428 | VicrylSummary page 1…Surgery PROCODE: OXF PREDICATE DEVICES: K080442 SERTM Surgical Scaffold K083898 TEl Biosciences SurgiMend Collagen Matrix K810428 Ethicon Vicryl Knitted Mesh DEVICE DESCRIPTION: SERITM Surgical Scaffold is a knitted, multifilament, bioengineered, long-term b… | 1981 |
What descends from it? (5)
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)
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 21 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 47 ancestors have a recall of any class.
- Of its descendants, K140533 (Tepha, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K080442.
How does its category compare?
All OXF devicesOXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OXF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OXF
Too few OXF 510(k)s in any year since 2007 to give a median.
Recalls per year · OXF
No recall names OXF since 2007.
Adverse event reports per year · OXF
1in 2023
MAUDE reports naming product code OXF, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 14 |
| 2014 | 0 | — | 0 | 129 |
| 2015 | 0 | — | 0 | 107 |
| 2016 | 0 | — | 0 | 52 |
| 2017 | 2 | — | 0 | 25 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SERI Surgical Scaffold is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123128: Seri Surgical Scaffold.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123128
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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