510(k) · Cleared
ClearedSERI Contour
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sofregen Medical, Inc. · OXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Cleared on Sep 22, 2017 as substantially equivalent to K123128 (Allergan, 2013) after a 30-day review. Its family tree reaches back 11 generations to 1992.
- Decided
- Sep 22, 2017
- Review
- 30 days
- Class
- Class II
- Product code
- OXF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K921895 (1992). 48 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet.
- Root · 11 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 7 generations between
- 3 generations backK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- 2 generations backK083898 SurgimendTei Biosciences, Inc. · 2009 · Recalled
- 1 generation backK123128 Seri Surgical ScaffoldAllergan · 2013
- This deviceK172545 SERI ContourSofregen Medical, Inc. · 2017
Show all 11 generations
- Root · 11 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 10 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 9 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 8 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 7 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 6 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 5 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 4 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 3 generations backK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- 2 generations backK083898 SurgimendTei Biosciences, Inc. · 2009 · Recalled
- 1 generation backK123128 Seri Surgical ScaffoldAllergan · 2013
- This deviceK172545 SERI ContourSofregen Medical, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −10 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −9 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −8 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −7 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −6 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −5 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −4 | K051766 | Orthomend | Tei Biosciences, Inc. | 2005 | — |
| −3 | K071807 | Orthomend Soft Tissue Matrix | Tei Biosciences, Inc. | 2007 | 4 |
| −2 | K083898 | Surgimend | Tei Biosciences, Inc. | 2009 | 3 |
| −1 | K123128 | Seri Surgical Scaffold | Allergan | 2013 | — |
| 0 (this device) | K172545 | SERI Contour | Sofregen Medical, 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 |
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? (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 |
|---|---|---|---|
| * | K123128 | Seri Surgical ScaffoldSummary page 4…ation: 21 CFR 878.3300 Regulatory Class: II Product Code: OXF Panel: General and Plastic Surgery 3. PREDICATE DEVICE Predicate Device: SERI® Surgical Scaffold (K123128) Reference Device: None 4. DEVICE DESCRIPTION SERI® Contour is a knitted, multifilament, bioengineered, long-term biore… | 2013 |
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 25 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 48 ancestors have a recall of any class.
- 1 other device also cites its predicate K123128.
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. 2017, 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® Contour 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/K172545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172545: SERI Contour.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172545
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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