510(k) · Cleared
ClearedColorado Therapeutics Xenograft Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Colorado Therapeutics, LLC · FTM Mesh, Surgical
Cleared on Oct 20, 2016 as substantially equivalent to K120605 (Covidien, LLC, 2012) and 1 other predicate after a 267-day review. Its family tree reaches back 8 generations to 1988. 1 later device descends from it.
- Decided
- Oct 20, 2016
- Review
- 267 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K881854 (1988). 30 ancestors in all, the oldest K830889 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 7 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 6 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 5 generations backK023778 DressskinTei Biosciences, Inc. · 2003
- 4 generations backK061407 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2006
- 3 generations backK083440 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2008
- 2 generations backK100261 Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc. · 2010 · Recalled
- 1 generation backK120605 Permacol Surgical ImplantCovidien, LLC · 2012
- This deviceK160181 Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC · 2016
- Descendant · cites it directly · 0 of its ownK172937 Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC · 2017
Most influential descendants
Showing 1 of 1 · See all- K172937Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −7 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −6 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −5 | K023778 | Dressskin | Tei Biosciences, Inc. | 2003 | — |
| −4 | K061407 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2006 | — |
| −3 | K083440 | Primatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2008 | — |
| −2 | K100261 | Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold | Tei Biosciences, Inc. | 2010 | 3 |
| −1 | K120605 | Permacol Surgical Implant | Covidien, LLC | 2012 | — |
| 0 (this device) | K160181 | Colorado Therapeutics Xenograft Implant | Colorado Therapeutics, LLC | 2016 | — |
| +1 | K172937 | Colorado Therapeutics Xenograft Implant | Colorado Therapeutics, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2000 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K120605 | Permacol Surgical ImplantSummary page 4…300) Device Class: Class II Product Code: FTM and OXK 3. PREDICATE DEVICES Predicate Device: Permacol™ Surgical Implant, Covidien (K120605) This product has not been subject to a design-related recall. Predicate Device: Surgisis®… | 2012 |
| * | K980431 | SurgisisSummary page 4…5) This product has not been subject to a design-related recall. Predicate Device: Surgisis® Biodesign® Hernia Graft, Cook Biotech (K980431) This product has not been subject to a design-related recall. Reference Devices: No referen… | 1998 |
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 |
|---|---|---|---|
| K172937 | Colorado Therapeutics Xenograft Implant | 2017 | 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 28 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 30 ancestors have a recall of any class.
- Of its descendants, K172937 (Colorado Therapeutics, LLC, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K120605.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Colorado Therapeutics Xenograft Implant is intended to be used for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.
It is supplied sterile.
It is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160181: Colorado Therapeutics Xenograft Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160181
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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