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 Feb 11, 2021 as substantially equivalent to K182898 (Paragon 28, Inc., 2019) after an 85-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Feb 11, 2021
- Review
- 85 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K904436 (1990). 16 ancestors in all, the oldest K813581 (1982). No later device cites it as a predicate yet.
- Root · 6 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 5 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 4 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 3 generations backK071704 Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc. · 2007
- 2 generations backK110145 Biomet Sports Medicine Juggerknot Soft AnchorBiomet, Inc. · 2011 · Recalled
- 1 generation backK182898 TenoTac Soft Tissue Fixation SystemParagon 28, Inc. · 2019
- This deviceK203385 TenoTac Soft Tissue Fixation SystemParagon 28, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −5 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −4 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −3 | K071704 | Sleeve and Button Soft Tissue Devices | Biomet Sports Medicine, Inc. | 2007 | — |
| −2 | K110145 | Biomet Sports Medicine Juggerknot Soft Anchor | Biomet, Inc. | 2011 | 3 |
| −1 | K182898 | TenoTac Soft Tissue Fixation System | Paragon 28, Inc. | 2019 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K182898 | TenoTac Soft Tissue Fixation SystemSummary page 4…on: 21 CFR 888.3040 Class: II Product Code: MBI Predicate Device: The TenoTac® Soft Tissue Fixation System (K182898) serves as the primary predicate device. Reference Device: The Zimmer Biomet (formerly Biomet Sports Medicine) JuggerKnot™ Soft… | 2019 |
| † | K110145 | Biomet Sports Medicine Juggerknot Soft Anchor | 2011 |
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 31 years and passes through 6 companies; a new generation was cleared every 5.7 years on median.
- 3 of the 16 ancestors have a recall of any class.
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. 2021, 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® device include: Foot & Ankle: Medial/lateral repair and reconstruction, mid and forefoot repair, hallux valgus repair, hallux malleus repair and reconstruction, metatarsal ligament/tendon repair and reconstruction including plantar plate attenuation and tear, and the correction of hammer toe, claw toe, mallet toe…
Read the full statement (115 words)
The TenoTac® Soft Tissue Fixation System is intended to be used for soft tissue to bone fixation.
Specific indications for the TenoTac® device include:
Foot & Ankle: Medial/lateral repair and reconstruction, mid and forefoot repair, hallux valgus repair, hallux malleus repair and reconstruction, metatarsal ligament/tendon repair and reconstruction including plantar plate attenuation and tear, and the correction of hammer toe, claw toe, mallet toe, crossover toe, floating toe, and any other lesser toe deformities, correction of metatarsophalangeal joint instability due to shortening from interphalangeal fusion, correction of metatarsophalangeal joint instability due to shortening from Weil osteotomy, Achilles tendon repair.
Hand & Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, tendon transfers in phalanx, Volar plate reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203385: TenoTac Soft Tissue Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203385
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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