510(k) · Cleared
ClearedSimparo Anchor Line Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Simparo, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Feb 4, 2023 as substantially equivalent to K140328 (Arthrex, Inc., 2014) and 1 other predicate after a 163-day review. Its family tree reaches back 12 generations to 1979.
- Decided
- Feb 4, 2023
- Review
- 163 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K792022 (1979). 65 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 8 generations between
- 3 generations backK090107 Mini TightropeArthrex, Inc. · 2009
- 2 generations backK133275 Mini TightropeArthrex, Inc. · 2014
- 1 generation backK140328 CMC Mini TightropeArthrex, Inc. · 2014
- This deviceK222574 Simparo Anchor Line Fixation SystemSimparo, Inc. · 2023
Show all 12 generations
- Root · 12 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 11 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 10 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 9 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 8 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 7 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 6 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 5 generations backK061925 Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc. · 2006
- 4 generations backK071978 Mini Tightrope FT Repair KitArthrex, Inc. · 2007
- 3 generations backK090107 Mini TightropeArthrex, Inc. · 2009
- 2 generations backK133275 Mini TightropeArthrex, Inc. · 2014
- 1 generation backK140328 CMC Mini TightropeArthrex, Inc. · 2014
- This deviceK222574 Simparo Anchor Line Fixation SystemSimparo, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −11 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −10 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −9 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −8 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −7 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −6 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −5 | K061925 | Mini Tightrope Repair Kit, Model AR-8911DS | Arthrex, Inc. | 2006 | — |
| −4 | K071978 | Mini Tightrope FT Repair Kit | Arthrex, Inc. | 2007 | — |
| −3 | K090107 | Mini Tightrope | Arthrex, Inc. | 2009 | — |
| −2 | K133275 | Mini Tightrope | Arthrex, Inc. | 2014 | — |
| −1 | K140328 | CMC Mini Tightrope | Arthrex, Inc. | 2014 | — |
| 0 (this device) | K222574 | Simparo Anchor Line Fixation System | Simparo, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 4 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 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? (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 |
|---|---|---|---|
| * | K140328 | CMC Mini TightropeSummary page 5…o the materials, design and indications for use to the following devices, previously cleared by the FDA: Primary Predicate: • Arthrex, Inc., CMC Mini TightRope, K140328 Secondary Predicate: • Axya Medical, Inc., AxyaLoop Anchor (5mm), K060970 The subject components for the Simparo Anchor… | 2014 |
| * | K060970 | Axyaloop Nonabsorbable Bone AnchorSummary page 5…y cleared by the FDA: Primary Predicate: • Arthrex, Inc., CMC Mini TightRope, K140328 Secondary Predicate: • Axya Medical, Inc., AxyaLoop Anchor (5mm), K060970 The subject components for the Simparo Anchor Line Fixation System are substantially similar to the Arthrex CMC Mini TightRope (… | 2006 |
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 44 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 65 ancestors have a recall of any class.
- 4 other devices also cite its predicate K140328.
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. 2023, 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 Simparo Anchor Line Fixation System, when used for fixation of bone-to-bone or soft-tissue-to-bone, is intended as an anchor fixation system, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.
Specifically, the Simparo Anchor Line Fixation System is indicated for carpometacarpal (CMC) joint arthroplasty as an adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpals when the trapezium has been excised due to osteoarthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222574 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222574: Simparo Anchor Line 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/K222574
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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