510(k) · Cleared
ClearedCollagen Tendon Sheet-D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rotation Medical, Inc. · FTM Mesh, Surgical
Cleared on Jan 8, 2013 as substantially equivalent to K112423 (Rotation Medical, Inc., 2011) after a 180-day review. Its family tree reaches back 5 generations to 1985. 5 later devices descend from it.
- Decided
- Jan 8, 2013
- Review
- 180 days
- Class
- Class II
- Product code
- FTM
- 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, 1 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 deviceK122048 Collagen Tendon Sheet-DRotation Medical, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK140300 Collagen Tendon Sheet-Ddi (CTS-Ddi)Rotation Medical, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK222501 Regeneten Bioinductive ImplantSmith and Nephew, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK242187 BioBrace®Conmed Corporation · 2024
- Descendant · 4 generations on · 0 of its ownK252946 BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK242631 REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div. · 2024
Most influential descendants
Showing 5 of 5 · See all- K140300Collagen Tendon Sheet-Ddi (CTS-Ddi)Rotation Medical, Inc. · 2014 · cites it directly4descendants
- K222501Regeneten Bioinductive ImplantSmith and Nephew, Inc. · 2023 · 2 generations on3descendants
- K242187BioBrace®Conmed Corporation · 2024 · 3 generations on1descendant
- K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation · 2025 · 4 generations on0descendants
- K242631REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div. · 2024 · 3 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) | K122048 | Collagen Tendon Sheet-D | Rotation Medical, Inc. | 2013 | — |
| +1 | K140300 | Collagen Tendon Sheet-Ddi (CTS-Ddi) | Rotation Medical, Inc. | 2014 | — |
| +2 | K222501 | Regeneten Bioinductive Implant | Smith and Nephew, Inc. | 2023 | — |
| +3 | K242187 | BioBrace® | Conmed Corporation | 2024 | — |
| +4 | K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | Conmed Corporation | 2025 | — |
| +3 | K242631 | REGENETEN™ Bioinductive Implant | Smith & Nephew Inc., Endoscopy Div. | 2024 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K112423 | Collagen Tendon SheetSummary page 1…FTM Legally Marketed Devices to Which Substantial Equivalence is Claimed Predicate Device(s): Collagen Tendon Sheet, K1 12423 Rotation Medical, Inc. Description of the Device Collagen Tendon Sheet-fl is a resorba… | 2011 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140300 | Collagen Tendon Sheet-Ddi (CTS-Ddi) | 2014 | 4 |
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 3 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K140300 (Rotation Medical, Inc., 2014) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K112423.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Collagen Tendon Sheet-D 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/K122048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122048: Collagen Tendon Sheet-D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122048
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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