510(k) · Cleared
ClearedGrappler Suture Anchor R3FLEX IOL 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 Mar 3, 2023 as substantially equivalent to K222091 (Paragon 28, Inc., 2022) and 2 other predicates after a 92-day review. Its family tree reaches back 12 generations to 1997. 2 later devices descend from it.
- Decided
- Mar 3, 2023
- Review
- 92 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K971358 (1997). 118 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 8 generations between
- 3 generations backK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
- 2 generations backK211002 Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · Recalled
- 1 generation backK222091 Grappler Suture Anchor SystemParagon 28, Inc. · 2022
- This deviceK223589 Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK240594 Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK253886 Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 11 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 10 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 9 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 8 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- 7 generations backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- 6 generations backK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
- 5 generations backK090124 Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2009 · Recalled
- 4 generations backK100012 Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W…Depuy Mitek, A Johnson & Johnson Company · 2010
- 3 generations backK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
- 2 generations backK211002 Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · Recalled
- 1 generation backK222091 Grappler Suture Anchor SystemParagon 28, Inc. · 2022
- This deviceK223589 Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −11 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −10 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −9 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −8 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| −7 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| −6 | K073412 | Gryphon BR and Healix BR Anchors | Depuy Mitek, A Johnson & Johnson Company | 2008 | 1 |
| −5 | K090124 | Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model… | Depuy Mitek, A Johnson & Johnson Company | 2009 | 2 |
| −4 | K100012 | Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon… | Depuy Mitek, A Johnson & Johnson Company | 2010 | — |
| −3 | K102298 | Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend… | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| −2 | K211002 | Grappler Suture Anchor System | Paragon 28, Inc. | 2021 | 1 |
| −1 | K222091 | Grappler Suture Anchor System | Paragon 28, Inc. | 2022 | — |
| 0 (this device) | K223589 | Grappler Suture Anchor R3FLEX IOL System | Paragon 28, Inc. | 2023 | — |
| +1 | K240594 | Grappler Suture Anchor R3FLEX IOL System | Paragon 28, Inc. | 2024 | — |
| +2 | K253886 | Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 9 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 12 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 12 | 0 |
| 2005 | 4 | 0 |
| 2006 | 7 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K222091 | Grappler Suture Anchor SystemSummary page 5…provided in titanium and all-suture and are connected by suture composed of UHMWPE. Predicate Device: Grappler Suture Anchor System (K222091, K211002) Additional Predicate Device: R3ACT Stabilization System (K211770) Reference Devices: B… | 2022 |
| * | K211002 | Grappler Suture Anchor SystemSummary page 5…in titanium and all-suture and are connected by suture composed of UHMWPE. Predicate Device: Grappler Suture Anchor System (K222091, K211002) Additional Predicate Device: R3ACT Stabilization System (K211770) Reference Devices: Baby Goril… | 2021 |
| * | K211770 | R3ACT Stabilization SystemSummary page 5…of UHMWPE. Predicate Device: Grappler Suture Anchor System (K222091, K211002) Additional Predicate Device: R3ACT Stabilization System (K211770) Reference Devices: Baby Gorilla®/Gorilla® Plating System (K222194), Substantial The proposed Grappler… | 2021 |
| † | K222194 | Baby Gorilla®/Gorilla® Plating System | 2022 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240594 | Grappler Suture Anchor R3FLEX IOL System | 2024 | 1 |
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 26 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 22 of the 118 ancestors have a recall of any class.
- Of its descendants, K240594 (Paragon 28, Inc., 2024) has gone furthest, with 1 descendant of its own.
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 Grappler Suture Anchor R3FLEX IOL System is intended for the fixation of soft tissue to bone including: Elbow: Biceps Tendon Reattachment, Lateral Epicondylitis Repair, Tennis Elbow Repair Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament…
Read the full statement (139 words)
The Grappler Suture Anchor R3FLEX IOL System is intended for the fixation of soft tissue to bone including:
Elbow: Biceps Tendon Reattachment, Lateral Epicondylitis Repair, Tennis Elbow Repair
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC
Foot/Ankle: Lateral Stabilization (Brostrom, Brostrom-Gould, Christman-Snook Repair), Ankle Ligament Repair, Medial Stabilization (Deltoid, Spring Ligament Repair), Achilles Tendon Repair, Metatarsal Ligament Repair, Syndesmosis Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, LisFranc Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Extra Capsular Reconstruction, Patellar Ligament and Tendon Avulsion Repair
Hip: Capsular Repair, Acetabular Labral Repair
The plate interacting anchors are only indicated for the above Hand/Wrist and Foot/Ankle indications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223589 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223589: Grappler Suture Anchor R3FLEX IOL System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223589
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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