510(k) · Cleared
ClearedGrappler Interference Screw 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 25, 2024 as substantially equivalent to K183690 (Paragon 28, Inc., 2019) after a 28-day review. Its family tree reaches back 2 generations to 2005. 1 later device descends from it.
- Decided
- Jul 25, 2024
- Review
- 28 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K051726 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK051726 Arthrex Tenodesis FamilyArthrex, Inc. · 2005
- 1 generation backK183690 Tenodesis Screw SystemParagon 28, Inc. · 2019
- This deviceK241864 Grappler Interference Screw SystemParagon 28, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK253886 Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −2 | K051726 | Arthrex Tenodesis Family | Arthrex, Inc. | 2005 | — |
| −1 | K183690 | Tenodesis Screw System | Paragon 28, Inc. | 2019 | — |
| 0 (this device) | K241864 | Grappler Interference Screw System | Paragon 28, Inc. | 2024 | — |
| +1 | K253886 | Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K183690 | Tenodesis Screw SystemSummary page 7…are provided in multiple lengths and sizes to accommodate variations in patient anatomy. Predicate Device: Grappler Interference Screw System (K183690) Substantial The Grappler Interference Screw System is substantially Equivalence: equivalent to the primary p… | 2019 |
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 |
|---|---|---|---|
| K253886 | Grappler Suture Anchor PCFD Tether System | 2026 | 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 19 years and passes through 2 companies; a new generation was cleared every 13.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K253886 (Paragon 28, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K183690.
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. 2024, 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 Interference Screw System is intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue and tendon transfers in surgeries of the shoulder, elbow, knee, foot/ankle, and hand/wrist. Specifically: Shoulder: » Rotator Cuff Repairs » Bankart Repair * SLAP Lesion Repair * Biceps Tenodesis » Acromio-Clavicular Separation Repair * Deltoid Repair » Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: * Lateral…
Read the full statement (209 words)
The Grappler Interference Screw System is intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue and tendon transfers in surgeries of the shoulder, elbow, knee, foot/ankle, and hand/wrist. Specifically:
Shoulder:
» Rotator Cuff Repairs
» Bankart Repair
* SLAP Lesion Repair
* Biceps Tenodesis
» Acromio-Clavicular Separation Repair
* Deltoid Repair
» Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle:
* Lateral Stabilization
* Medial Stabilization
* Achilles Tendon Repair
» Hallux Valgus Reconstruction
» Midfoot Reconstruction (e.g. reconstruction of the Spring Ligament to address Progressive Collapsing Flatfoot Deformity)
* Hindfoot Reconstruction (e.g. reconstruction of the Interosseous Talocalcaneal Ligament and/or Spring Ligament to address Progressive Collapsing Flatfoot Deformity)
» Metatarsal Ligament Repair
* Flexor Hallucis Longus Transfer for Achilles Tendon Reconstruction, and
* Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Reconstruction.
Knee:
* Anterior Cruciate Ligament Repair
* Medial Collateral Ligament Repair
» Lateral Collateral Ligament Repair
* Patellar Tendon Repair
* Posterior Oblique Ligament Repair
* llliotibial Band Tenodesis
Elbow:
* Biceps Tendon Reattachment
* Ulnar or Radial Collateral Ligament Reconstruction
Hand/Wrist:
» Scapholunate Ligament Reconstruction
» Ulnar Collateral Ligament Reconstruction
» Radial Collateral Ligament Reconstruction
» Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
Carpal Ligament Reconstructions and repairs
» Ligament Reconstruction and Tendon Interposition.
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/K241864 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241864: Grappler Interference Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241864
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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