510(k) · Cleared
Recalled · Class II · 2022Grappler Suture Anchor 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 Jul 7, 2021 as substantially equivalent to K102298 (Depuy Mitek, A Johnson & Johnson Company, 2011) after a 96-day review. Its family tree reaches back 10 generations to 1997. 6 later devices descend from it. It has been recalled once.
- Decided
- Jul 7, 2021
- Review
- 96 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 10 generations to K971358 (1997). 54 ancestors in all, the oldest K930893 (1993). 6 later devices descend from it, 6 citing it directly.
- Root · 10 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 6 generations between
- 3 generations backK090124 Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2009 · Recalled
- 2 generations backK100012 Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W…Depuy Mitek, A Johnson & Johnson Company · 2010
- 1 generation backK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
- This deviceK211002 Grappler Suture Anchor SystemParagon 28, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK222091 Grappler Suture Anchor SystemParagon 28, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK223589 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 · cites it directly · 0 of its ownK262047 Grappler Suture Anchor SystemParagon 28, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253886 Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 9 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 8 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 7 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 6 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- 5 generations backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- 4 generations backK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
- 3 generations backK090124 Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2009 · Recalled
- 2 generations backK100012 Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W…Depuy Mitek, A Johnson & Johnson Company · 2010
- 1 generation backK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
- This deviceK211002 Grappler Suture Anchor SystemParagon 28, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K222091Grappler Suture Anchor SystemParagon 28, Inc. · 2022 · cites it directly3descendants
- K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2023 · cites it directly2descendants
- K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2024 · cites it directly1descendant
- K262047Grappler Suture Anchor SystemParagon 28, Inc. · 2026 · cites it directly0descendants
- K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −9 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −8 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −7 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −6 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| −5 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| −4 | K073412 | Gryphon BR and Healix BR Anchors | Depuy Mitek, A Johnson & Johnson Company | 2008 | 1 |
| −3 | K090124 | Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model… | Depuy Mitek, A Johnson & Johnson Company | 2009 | 2 |
| −2 | K100012 | Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon… | Depuy Mitek, A Johnson & Johnson Company | 2010 | — |
| −1 | K102298 | Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend… | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| 0 (this device) | K211002 | Grappler Suture Anchor System | Paragon 28, Inc. | 2021 | — |
| +1 | K222091 | Grappler Suture Anchor System | Paragon 28, Inc. | 2022 | — |
| +1 | K223589 | Grappler Suture Anchor R3FLEX IOL System | Paragon 28, Inc. | 2023 | — |
| +1 | K240594 | Grappler Suture Anchor R3FLEX IOL System | Paragon 28, Inc. | 2024 | — |
| +1 | K262047 | Grappler Suture Anchor System | Paragon 28, Inc. | 2026 | — |
| +1 | K253886 | Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 9 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K102298 | Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Summary page 5…Each anchor is accompanied by round suture or suture tape composed of UHMWPE and PGLA. Predicate Device: DePuy Synthes TransTend Anchors (K102298) Reference Devices: DePuy Synthes Healix Advance with DYNA+TAPE (K191483) Parcus Medical, LLC Parcu… | 2011 |
| † | K191483 | HEALIX ADVANCE Anchor with DYNA+TAPE Sutures | 2019 |
| † | K201083 | Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors | 2020 |
| † | K191227 | Paratrooper Plantar Plate Repair System | 2020 |
| † | K153307 | HS SutureTape | 2016 |
| † | K100006 | HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon… | 2010 |
| † | K190817 | HS Fiber | 2019 |
| † | K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II… | 2019 |
| † | K183690 | Tenodesis Screw System | 2019 |
| † | K182898 | TenoTac Soft Tissue Fixation System | 2019 |
| † | K120556 | Vilet Vilet Quick | 2012 |
| † | K123668 | Orthocord | 2013 |
What descends from it? (6)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222091 | Grappler Suture Anchor System | 2022 | 3 |
| K223589 | Grappler Suture Anchor R3FLEX IOL System | 2023 | 2 |
| K240594 | Grappler Suture Anchor R3FLEX IOL System | 2024 | 1 |
| K262047 | Grappler Suture Anchor System | 2026 | 0 |
| K253886 | Grappler Suture Anchor PCFD Tether System | 2026 | 0 |
| K231867 | Grappler Suture Anchor System | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 13, 2022 | Class II | Z-1776-2022 | Device Design | Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 13 of the 54 ancestors have a recall of any class.
- Of its descendants, K222091 (Paragon 28, Inc., 2022) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K102298.
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 GRAPPLER™ Suture Anchor 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 (124 words)
The GRAPPLER™ Suture Anchor 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, Chrisman-Snook Repair), Ankle Ligament Repair, Medial Stabilization (Deltoid Repair, Spring Ligament Reconstruction), 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
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/K211002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211002: Grappler Suture Anchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211002
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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