510(k) · Cleared
ClearedTAPESTRY Biointegrative Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Embody, Inc. · OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Cleared on Oct 19, 2020 as substantially equivalent to K112423 (Rotation Medical, Inc., 2011) after a 130-day review. Its family tree reaches back 5 generations to 1985. 5 later devices descend from it.
- Decided
- Oct 19, 2020
- Review
- 130 days
- Class
- Class II
- Product code
- OWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K850785 (1985). 10 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK850785 Fastube Nerve Regeneration DeviceResearch Medical, Inc. · 1985
- 4 generations backK012814 Collagen Nerve CuffCollagen Matrix, Inc. · 2001
- 3 generations backK060952 Collagen Nerve WrapCollagen Matrix, Inc. · 2006
- 2 generations backK080452 Collagen Tendon WrapCollagen Matrix, Inc. · 2008
- 1 generation backK112423 Collagen Tendon SheetRotation Medical, Inc. · 2011
- This deviceK201572 TAPESTRY Biointegrative ImplantEmbody, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK212306 Tapestry Biointegrative ImplantEmbody, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK252647 Tapestry Biointegrative ImplantEmbody, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK250021 RotiumNanofiber Solutions, LLC · 2025
- Descendant · cites it directly · 0 of its ownK222220 SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC., · 2023
- Descendant · 2 generations on · 0 of its ownK220867 Tapestry Biointegrative ImplantEmbody, Inc. · 2022
Most influential descendants
Showing 5 of 5 · See all- K212306Tapestry Biointegrative ImplantEmbody, Inc. · 2021 · cites it directly2descendants
- K252647Tapestry Biointegrative ImplantEmbody, Inc. · 2025 · 2 generations on0descendants
- K250021RotiumNanofiber Solutions, LLC · 2025 · cites it directly0descendants
- K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC., · 2023 · cites it directly0descendants
- K220867Tapestry Biointegrative ImplantEmbody, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K850785 | Fastube Nerve Regeneration Device | Research Medical, Inc. | 1985 | — |
| −4 | K012814 | Collagen Nerve Cuff | Collagen Matrix, Inc. | 2001 | — |
| −3 | K060952 | Collagen Nerve Wrap | Collagen Matrix, Inc. | 2006 | — |
| −2 | K080452 | Collagen Tendon Wrap | Collagen Matrix, Inc. | 2008 | — |
| −1 | K112423 | Collagen Tendon Sheet | Rotation Medical, Inc. | 2011 | — |
| 0 (this device) | K201572 | TAPESTRY Biointegrative Implant | Embody, Inc. | 2020 | — |
| +1 | K212306 | Tapestry Biointegrative Implant | Embody, Inc. | 2021 | — |
| +2 | K252647 | Tapestry Biointegrative Implant | Embody, Inc. | 2025 | — |
| +1 | K250021 | Rotium | Nanofiber Solutions, LLC | 2025 | — |
| +1 | K222220 | SpinMedix Absorbable Fibrous Membrane | Celestray Biotech Company, LLC., | 2023 | — |
| +2 | K220867 | Tapestry Biointegrative Implant | Embody, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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 OWY? 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 OWY device
- #1 K222501 Regeneten Bioinductive Implantscore 13.1 · 7 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 |
|---|---|---|---|
| * | K112423 | Collagen Tendon SheetSummary page 5…Mesh, Surgical Regulation No.: 878.3300 Product Code: OWY Predicate Device: Rotation Medical Inc. Collagen Tendon Sheet, K112423 Reference Device: Surgi Wrap MAST Tendon Sheet, K063648 Owner/Submitter: Embody, Inc.… | 2011 |
| † | K063648 | Surgi-Wrap Mast Tendon Sheet | 2007 |
What descends from it? (5)
3 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 35 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K212306 (Embody, Inc., 2021) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K112423.
How does its category compare?
All OWY devicesOWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OWY
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWY
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWY
No recall names OWY since 2007.
Adverse event reports per year · OWY
28in 2025
MAUDE reports naming product code OWY, 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 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 1 | — | 0 | 14 |
| 2021 | 1 | — | 0 | 25 |
| 2022 | 1 | — | 0 | 15 |
| 2023 | 1 | — | 0 | 35 |
| 2024 | 1 | — | 0 | 24 |
| 2025 | 4 | 131 | 0 | 28 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
TAPESTRY® Biointegrative Implant is indicated for the 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/K201572 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201572: TAPESTRY Biointegrative Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201572
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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