510(k) · Cleared
ClearedSpinMedix Absorbable Fibrous Membrane
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Celestray Biotech Company, LLC., · OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Cleared on Jul 6, 2023 as substantially equivalent to K063648 (Mast Biosurgery USA, Inc., 2007) and 1 other predicate after a 346-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Jul 6, 2023
- Review
- 346 days
- Class
- Class II
- Product code
- OWW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K921895 (1992). 53 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 10 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 6 generations between
- 3 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 2 generations backK060989 Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc. · 2006 · Recalled
- 1 generation backK063648 Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc. · 2007
- This deviceK222220 SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC., · 2023
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 backK060989 Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc. · 2006 · Recalled
- 1 generation backK063648 Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc. · 2007
- This deviceK222220 SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC., · 2023
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 | K060989 | Tissuemend Soft Tissue Repair Matrix | Tei Biosciences, Inc. | 2006 | 1 |
| −1 | K063648 | Surgi-Wrap Mast Tendon Sheet | Mast Biosurgery USA, Inc. | 2007 | — |
| 0 (this device) | K222220 | SpinMedix Absorbable Fibrous Membrane | Celestray Biotech Company, LLC., | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 6 | 0 |
| 2000 | 4 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 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 OWW? 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 OWW device
- #1 K241906 BioBrace® Reinforced Implantscore 17.1 · 12 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 |
|---|---|---|---|
| * | K063648 | Surgi-Wrap Mast Tendon SheetSummary page 4…OWW, FTL Legally Marketed Devices to Which Substantial Equivalence is Claimed Predicate Device(s) Surgi-Wrap MAST Tendon Sheet, K063648 MAST Biosurgery Inc. San Diego, CA TAPESTRY® Biointegrative Impla… | 2007 |
| * | K201572 | TAPESTRY Biointegrative ImplantSummary page 4…urgi-Wrap MAST Tendon Sheet, K063648 MAST Biosurgery Inc. San Diego, CA TAPESTRY® Biointegrative Implant, K201572 Embody, Inc. Norfolk, VA Description of the device SpinMedix Absorbable Fibrous Membrane provi… | 2020 |
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 31 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 53 ancestors have a recall of any class.
- 1 other device also cites its predicate K063648.
How does its category compare?
All OWW devicesOWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OWW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWW
81in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWW
No recall names OWW since 2007.
Adverse event reports per year · OWW
2in 2025
MAUDE reports naming product code OWW, 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 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 3 | 81 | 0 | 0 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SpinMedix Fibrous Membrane is indicated for management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222220 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222220: SpinMedix Absorbable Fibrous Membrane.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222220
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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