510(k) · Cleared
ClearedTYBR Collagen Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tybr Health · OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Cleared on Jun 6, 2025 as substantially equivalent to K213163 (Alafair Biosciences, Inc., 2021) and 1 other predicate after a 141-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Jun 6, 2025
- Review
- 141 days
- Class
- Class II
- Product code
- OWY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K000019 (2000). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK000019 Single Size Tendon SpacerMedist International · 2000
- 5 generations backK053655 Tendon Wrap Tendon ProtectorIntegra LifeSciences Corporation · 2006
- 4 generations backK160364 VersaWrap Tendon ProtectorAlafair Biosciences, Inc. · 2016
- 3 generations backK200311 VersaWrap Tendon ProtectorAlafair Biosciences, Inc. · 2020
- 2 generations backK203600 VersaWrapAlafair Biosciences, Inc. · 2021
- 1 generation backK213163 VersaWrapAlafair Biosciences, Inc. · 2021
- This deviceK250109 TYBR Collagen GelTybr Health · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000019 | Single Size Tendon Spacer | Medist International | 2000 | — |
| −5 | K053655 | Tendon Wrap Tendon Protector | Integra LifeSciences Corporation | 2006 | — |
| −4 | K160364 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | 2016 | — |
| −3 | K200311 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | 2020 | — |
| −2 | K203600 | VersaWrap | Alafair Biosciences, Inc. | 2021 | — |
| −1 | K213163 | VersaWrap | Alafair Biosciences, Inc. | 2021 | — |
| 0 (this device) | K250109 | TYBR Collagen Gel | Tybr Health | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K213163 | VersaWrapSummary page 5…roduct Code OWY (Primary), FTM Panel Orthopedic Predicates Primary Predicate Alafair Biosciences - VersaWrap (K213163) Additional Predicate MiroMatrix – Miromatrix Biological Mesh (K162570) Device Description TYBR Collagen Gel is a nat… | 2021 |
| * | K162570 | Miromatrix Biological Mesh TWSummary page 5…Orthopedic Predicates Primary Predicate Alafair Biosciences - VersaWrap (K213163) Additional Predicate MiroMatrix – Miromatrix Biological Mesh (K162570) Device Description TYBR Collagen Gel is a naturally-derived collagenous semi-permeable barrier device that conforms to the appl… | 2017 |
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 4 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 1 other device also cites its predicate K213163.
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. 2025, 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?
TYBR Collagen Gel is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligament.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250109: TYBR Collagen Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250109
Report an extraction error
Are you the manufacturer?
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