510(k) · Cleared
ClearedMiromatrix Biological Mesh TW
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miromatrix Medical, Inc. · FTM Mesh, Surgical
Cleared on Feb 16, 2017 as substantially equivalent to K053655 (Integra LifeSciences Corporation, 2006) after a 154-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Feb 16, 2017
- Review
- 154 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000019 (2000). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK000019 Single Size Tendon SpacerMedist International · 2000
- 1 generation backK053655 Tendon Wrap Tendon ProtectorIntegra LifeSciences Corporation · 2006
- This deviceK162570 Miromatrix Biological Mesh TWMiromatrix Medical, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK250109 TYBR Collagen GelTybr Health · 2025
Most influential descendants
Showing 1 of 1 · See all- K250109TYBR Collagen GelTybr Health · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000019 | Single Size Tendon Spacer | Medist International | 2000 | — |
| −1 | K053655 | Tendon Wrap Tendon Protector | Integra LifeSciences Corporation | 2006 | — |
| 0 (this device) | K162570 | Miromatrix Biological Mesh TW | Miromatrix Medical, Inc. | 2017 | — |
| +1 | K250109 | TYBR Collagen Gel | Tybr Health | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 FTM? 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 FTM device
- #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 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? (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 |
|---|---|---|---|
| * | K053655 | Tendon Wrap Tendon ProtectorSummary page 4…300 Regulatory Class: II Product Code: FTM, OWW Panel: General and Plastic Surgery 3. PREDICATE DEVICE Predicate Device: Integra Tendon Wrap™ Tendon Protector (K053655) Reference Device: Miromatrix Biological Mesh (K134033) 4. DEVICE DESCRIPTION The Miromatrix Biological Mesh TW is an i… | 2006 |
| † | K134033 | Miromatrix Biological Mesh | 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 |
|---|---|---|---|
| K250109 | TYBR Collagen Gel | 2025 | 0 |
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 17 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K250109 (Tybr Health, 2025) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K053655.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, 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 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Miromatrix Biological Mesh TW 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/K162570 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162570: Miromatrix Biological Mesh TW.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162570
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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