510(k) · Cleared
Recalled · Class II · 2016GalaSHAPE 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tepha, Inc. · OOD Surgical Film
Cleared on Aug 23, 2016 as substantially equivalent to K140533 (Tepha, Inc., 2014) after a 127-day review. Its family tree reaches back 12 generations to 1992. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 23, 2016
- Review
- 127 days
- Class
- Class II
- Product code
- OOD
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 12 generations to K921895 (1992). 61 ancestors in all, the oldest K810428 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 8 generations between
- 3 generations backK083898 SurgimendTei Biosciences, Inc. · 2009 · Recalled
- 2 generations backK123128 Seri Surgical ScaffoldAllergan · 2013
- 1 generation backK140533 Galaflex MeshTepha, Inc. · 2014
- This deviceK161092 GalaSHAPE 3DTepha, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK162922 GalaFORM 3DTepha, Inc. · 2017
Show all 12 generations
- Root · 12 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 11 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 10 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 9 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 8 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 7 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 6 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 5 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 4 generations backK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- 3 generations backK083898 SurgimendTei Biosciences, Inc. · 2009 · Recalled
- 2 generations backK123128 Seri Surgical ScaffoldAllergan · 2013
- 1 generation backK140533 Galaflex MeshTepha, Inc. · 2014
- This deviceK161092 GalaSHAPE 3DTepha, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K162922GalaFORM 3DTepha, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −11 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −10 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −9 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −8 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −7 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −6 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −5 | K051766 | Orthomend | Tei Biosciences, Inc. | 2005 | — |
| −4 | K071807 | Orthomend Soft Tissue Matrix | Tei Biosciences, Inc. | 2007 | 4 |
| −3 | K083898 | Surgimend | Tei Biosciences, Inc. | 2009 | 3 |
| −2 | K123128 | Seri Surgical Scaffold | Allergan | 2013 | — |
| −1 | K140533 | Galaflex Mesh | Tepha, Inc. | 2014 | — |
| 0 (this device) | K161092 | GalaSHAPE 3D | Tepha, Inc. | 2016 | — |
| +1 | 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 | 2 | 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 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 OOD? 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 OOD device
- #1 K233999 GalaFLEX LITE Scaffoldscore 7.1 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K140533 | Galaflex MeshSummary page 4…reconstructive surgery CLASSIFICATION REG/PANEL: CFR §878.3300 / General and Plastic Surgery PROCODE: OOD PREDICATE DEVICE: K140533 GalaFLEX® scaffold DEVICE DESCRIPTION: GalaSHAPE 3D is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (… | 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 |
|---|---|---|---|
| K162922 | GalaFORM 3D | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 21, 2016 | Class II | Z-0948-2017 | Process design | Endotoxin values from testing of retains slightly exceeded the established specification. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 61 ancestors have a recall of any class.
- Of its descendants, K162922 (Tepha, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K140533.
How does its category compare?
All OOD devicesOOD Surgical Film: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OOD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OOD
Too few OOD 510(k)s in any year since 2007 to give a median.
Recalls per year · OOD
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OOD
111in 2025
MAUDE reports naming product code OOD, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 2 | — | 1 | 9 |
| 2017 | 1 | — | 0 | 33 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 0 | — | 0 | 17 |
| 2020 | 0 | — | 0 | 71 |
| 2021 | 1 | — | 0 | 98 |
| 2022 | 0 | — | 0 | 430 |
| 2023 | 0 | — | 0 | 126 |
| 2024 | 1 | — | 0 | 196 |
| 2025 | 0 | — | 0 | 111 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
GalaSHAPE™ 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and 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. GalaSHAPE™ 3D is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161092: GalaSHAPE 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161092
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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