510(k) Report

510(k) · Cleared

Cleared

Tenodesis Screw System

K183690510(k) TraditionalCleared Mar 1, 201960-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Paragon 28, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Mar 1, 2019 as substantially equivalent to K051726 (Arthrex, Inc., 2005) after a 60-day review. Its family tree reaches back 1 generation to 2005. 3 later devices descend from it.

Decided
Mar 1, 2019
Review
60 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K051726 (2005). 3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2024: 1 descendant cleared2020: 1 descendant cleared2026: 1 descendant clearedK051726 · Arthrex Tenodesis Family · Arthrex, Inc. · 200520052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 1 descendant K051726 · Arthrex Tenodesis Family · Arthrex, Inc. · 20050
  1. Root · 1 generation backK051726 Arthrex Tenodesis FamilyArthrex, Inc. · 2005
  2. This deviceK183690 Tenodesis Screw SystemParagon 28, Inc. · 2019
  3. Descendant · cites it directly · 1 of its ownK241864 Grappler Interference Screw SystemParagon 28, Inc. · 2024
  4. Descendant · 2 generations on · 0 of its ownK253886 Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc. · 2026
  5. Descendant · cites it directly · 0 of its ownK200428 Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc. · 2020

Most influential descendants

Showing 3 of 3 · See all
  • K241864Grappler Interference Screw SystemParagon 28, Inc. · 2024 · cites it directly1descendant
  • K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc. · 2026 · 2 generations on0descendants
  • K200428Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K051726Arthrex Tenodesis FamilyArthrex, Inc.2005—
0 (this device)K183690Tenodesis Screw SystemParagon 28, Inc.2019—
+1K241864Grappler Interference Screw SystemParagon 28, Inc.2024—
+2K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.2026—
+1K200428Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202410
202610
FIG. 1 — Lineage of K183690, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K051726Arthrex Tenodesis Family
Summary page 6
…er ASTM F2026. The instrumentation is primarily manufactured from medical grades of stainless steel. Primary K051726, Arthrex Tenodesis Screw Family Predicate: Comparison to The subject Tenodesis Screw System and Arthrex Tenodesis Predica…
Arthrex, Inc.2005—

Also cleared against K051726: 12 other devices →

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K241864Grappler Interference Screw SystemParagon 28, Inc.20241
K200428Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc.20200

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?

  • Its one ancestor has no recall.
  • Of its descendants, K241864 (Paragon 28, Inc., 2024) has gone furthest, with 1 descendant of its own.
  • 12 other devices also cite its predicate K051726.

How does its category compare?

All MBI devices

MBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · MBI

27in 2025

2007: 162008: 102009: 192010: 172011: 302012: 242013: 312014: 232015: 232016: 172017: 172018: 162019: 312020: 352021: 182022: 192023: 522024: 222025: 272026 (partial year): 30
2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007: 80 days median2008: 69 days median2009: 82 days median2010: 76 days median2011: 75 days median2012: 94 days median2013: 100 days median2014: 101 days median2015: 85 days median2016: 94 days median2017: 70 days median2018: 91 days median2019: 90 days median2020: 83 days median2021: 107 days median2022: 64 days median2023: 57 days median2024: 30 days median2025: 58 days median2026 (partial year): 63 days median
2007high 107 (2021) · low 30 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MBI

1in 2025

2007: 242008: 62009: 22010: 32011: 232012: 62013: 22017: 42018: 22020: 12023: 12024: 12025: 1
2007high 24 (2007) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MBI

3,826in 2025

2007: 2402008: 3382009: 3552010: 2912011: 3282012: 3712013: 4422014: 5042015: 5072016: 7952017: 6752018: 1,0722019: 1,3032020: 1,4542021: 1,8902022: 1,5912023: 2,5032024: 3,7792025: 3,826
2007high 3,826 (2025) · low 240 (2007)2025

MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007168024240
200810696338
200919822355
201017763291
2011307523328
201224946371
2013311002442
2014231010504
201523850507
201617940795
201717704675
2018169121,072
2019319001,303
2020358311,454
20211810701,890
2022196401,591
2023525712,503
2024223013,779
2025275813,826
202630630—

What is it indicated for?

The Tenodesis 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…

Read the full statement (149 words)

The Tenodesis 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

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

Illiotibial 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.

Also cleared against K051726

12 other devices cite the same predicate.

  • K252664GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda. · 2025
  • K200725Citregen Tendon Interference Screw and CitrelockAcuitive Technologies · 2020
  • K181513Arthrex PushLock Tenodesis AnchorArthrex, Inc. · 2018
  • K151701Tenodesis screw systemNormed Medizin-Technik GmbH · 2016
  • K141290Helical Ridge Peek Interference ScrewMedShape, Inc. · 2014
  • K130716Bioretec Activascrew InterferenceBioretec, Ltd. · 2013

More from Paragon 28, Inc.

54 FDA decisions under this applicant name. See the company

  • K261120APEX 3D S Diamond TibiaParagon 28, Inc. · 2026
  • K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc. · 2026
  • K261121Megalodon Dynamic Compression SystemParagon 28, Inc. · 2026
  • K262047Grappler Suture Anchor SystemParagon 28, Inc. · 2026
  • K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc. · 2026

Recent decisions in MBI

The MBI category page

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K263352TeKBrace Knotless AnchorTheraMicro · 2026
  • K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. · 2026
  • K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc. · 2026
  • K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026

https://510kreport.com/device/K183690 · printed Nov 6, 2026

Cite this page

510(k) Report. “K183690: Tenodesis 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/K183690

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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