510(k) · Cleared
ClearedTenoTac Soft Tissue Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon 28, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jan 14, 2019 as substantially equivalent to K110145 (Biomet, Inc., 2011) after a 90-day review. Its family tree reaches back 5 generations to 1990. 1 later device descends from it.
- Decided
- Jan 14, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K904436 (1990). 15 ancestors in all, the oldest K813581 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 4 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 3 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 2 generations backK071704 Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc. · 2007
- 1 generation backK110145 Biomet Sports Medicine Juggerknot Soft AnchorBiomet, Inc. · 2011 · Recalled
- This deviceK182898 TenoTac Soft Tissue Fixation SystemParagon 28, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK203385 TenoTac Soft Tissue Fixation SystemParagon 28, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K203385TenoTac Soft Tissue Fixation SystemParagon 28, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −4 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −3 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −2 | K071704 | Sleeve and Button Soft Tissue Devices | Biomet Sports Medicine, Inc. | 2007 | — |
| −1 | K110145 | Biomet Sports Medicine Juggerknot Soft Anchor | Biomet, Inc. | 2011 | 3 |
| 0 (this device) | K182898 | TenoTac Soft Tissue Fixation System | Paragon 28, Inc. | 2019 | — |
| +1 | K203385 | TenoTac Soft Tissue Fixation System | Paragon 28, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 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 |
|---|---|---|---|
| * | K110145 | Biomet Sports Medicine Juggerknot Soft AnchorSummary page 4…n various sizes and lengths to accommodate different bone sizes. Predicate Devices: The Zimmer Biomet (formerly Biomet Sports Medicine) JuggerKnot™ Soft Anchors device (K110145) serves as the predicate device. Paragon 28, Inc Page 1 o… | 2011 |
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 |
|---|---|---|---|
| K203385 | TenoTac Soft Tissue Fixation System | 2021 | 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 29 years and passes through 6 companies; a new generation was cleared every 5.7 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K203385 (Paragon 28, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K110145.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The TenoTac® Soft Tissue Fixation System is intended to be used for soft tissue to bone fixation.
Specific indications for the TenoTac® include:
- Foot & Ankle: Medial/lateral repair and reconstruction, mid and forefoot repair, hallux valgus repair, metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
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/K182898 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182898: TenoTac Soft Tissue Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182898
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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