510(k) · Cleared
ClearedGalaFORM 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 Feb 23, 2017 as substantially equivalent to K161092 (Tepha, Inc., 2016) and 1 other predicate after a 128-day review. Its family tree reaches back 13 generations to 1992.
- Decided
- Feb 23, 2017
- Review
- 128 days
- Class
- Class II
- Product code
- OOD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K921895 (1992). 62 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet.
- Root · 13 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 9 generations between
- 3 generations backK123128 Seri Surgical ScaffoldAllergan · 2013
- 2 generations backK140533 Galaflex MeshTepha, Inc. · 2014
- 1 generation backK161092 GalaSHAPE 3DTepha, Inc. · 2016 · Recalled
- This deviceK162922 GalaFORM 3DTepha, Inc. · 2017
Show all 13 generations
- Root · 13 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 12 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 11 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 10 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 9 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 8 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 7 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 6 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 5 generations backK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- 4 generations backK083898 SurgimendTei Biosciences, Inc. · 2009 · Recalled
- 3 generations backK123128 Seri Surgical ScaffoldAllergan · 2013
- 2 generations backK140533 Galaflex MeshTepha, Inc. · 2014
- 1 generation backK161092 GalaSHAPE 3DTepha, Inc. · 2016 · Recalled
- This deviceK162922 GalaFORM 3DTepha, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −12 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −11 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −10 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −9 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −8 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −7 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −6 | K051766 | Orthomend | Tei Biosciences, Inc. | 2005 | — |
| −5 | K071807 | Orthomend Soft Tissue Matrix | Tei Biosciences, Inc. | 2007 | 4 |
| −4 | K083898 | Surgimend | Tei Biosciences, Inc. | 2009 | 3 |
| −3 | K123128 | Seri Surgical Scaffold | Allergan | 2013 | — |
| −2 | K140533 | Galaflex Mesh | Tepha, Inc. | 2014 | — |
| −1 | K161092 | GalaSHAPE 3D | Tepha, Inc. | 2016 | 1 |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K161092 | GalaSHAPE 3DSummary page 4…ASSIFICATION REG/PANEL: CFR §878.3300 / General and Plastic Surgery PROCODE: OOD PREDICATE DEVICES: K161092 GalaSHAPE™ scaffold K140533 GalaFLEX® scaffold DEVICE DESCRIPTION: GalaFORM 3D scaffold is a bioresorbable surgical mesh manuf… | 2016 |
| * | K140533 | Galaflex MeshSummary page 4…CFR §878.3300 / General and Plastic Surgery PROCODE: OOD PREDICATE DEVICES: K161092 GalaSHAPE™ scaffold K140533 GalaFLEX® scaffold DEVICE DESCRIPTION: GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4- hydroxy… | 2014 |
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 1.5 years on median.
- 5 of the 62 ancestors have a recall of any class.
How does its category compare?
All OOD devicesOOD Surgical Film: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
GalaFORM 3D scaffold 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. GalaFORM 3D scaffold 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/K162922 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162922: GalaFORM 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162922
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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