510(k) · Cleared
ClearedArthrex Trimit Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HWC Screw, Fixation, Bone
Cleared on Nov 4, 2004 after a 182-day review. The FDA summary names no predicate by number. 40 later devices descend from it.
- Decided
- Nov 4, 2004
- Review
- 182 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
40 later devices descend from it, 4 citing it directly.
- This deviceK041189 Arthrex Trimit FamilyArthrex, Inc. · 2004
- Descendant · cites it directly · 33 of its ownK061925 Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc. · 2006
- Descendant · 2 generations on · 22 of its ownK071978 Mini Tightrope FT Repair KitArthrex, Inc. · 2007
- Descendant · 2 generations on · 21 of its ownK090107 Mini TightropeArthrex, Inc. · 2009
- Descendant · 3 generations on · 11 of its ownK133275 Mini TightropeArthrex, Inc. · 2014
- Descendant · 4 generations on · 6 of its ownK140328 CMC Mini TightropeArthrex, Inc. · 2014
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc. · 2006 · cites it directly33descendants
- K071978Mini Tightrope FT Repair KitArthrex, Inc. · 2007 · 2 generations on22descendants
- K090107Mini TightropeArthrex, Inc. · 2009 · 2 generations on21descendants
- K133275Mini TightropeArthrex, Inc. · 2014 · 3 generations on11descendants
- K140328CMC Mini TightropeArthrex, Inc. · 2014 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041189 | Arthrex Trimit Family | Arthrex, Inc. | 2004 | — |
| +1 | K061925 | Mini Tightrope Repair Kit, Model AR-8911DS | Arthrex, Inc. | 2006 | — |
| +2 | K071978 | Mini Tightrope FT Repair Kit | Arthrex, Inc. | 2007 | — |
| +2 | K090107 | Mini Tightrope | Arthrex, Inc. | 2009 | — |
| +3 | K133275 | Mini Tightrope | Arthrex, Inc. | 2014 | — |
| +4 | K140328 | CMC Mini Tightrope | Arthrex, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (40)
See all 404 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K061925 (Arthrex, Inc., 2006) has gone furthest, with 33 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Arthrex TRIMit TM Family, made of polylactide (PLLA), are implants for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts of the foot, ankle, hand, wrist, elbow, and shoulder in the presence of appropriate brace and/or immobilization. More specific surgeries include: Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair…
Read the full statement (197 words)
The Arthrex TRIMit TM Family, made of polylactide (PLLA), are implants for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts of the foot, ankle, hand, wrist, elbow, and shoulder in the presence of appropriate brace and/or immobilization. More specific surgeries include:
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 (proximal and chevron), Midfoot Reconstruction, Metacarpal and Metatarsal fusions and Ligament Repair, Tendon transfer in the foot/ankle such as Posterior Tibial Tendon Transfer for Posterior Tibial Tendon Dysfunction, Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Dysfunction, Kidner transfer, Extensor Hallucis Longus transfer, Flexor Hallucis Longus for Achilles Tendon reconstruction, Weber A and B fractures, Lateral and Medial Malleolus Ankle Fracture, Osteochondritis Dissecans, Fractures of the Distal Radius, tibial tubercle avulsions in adolescence
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, phalangeal fracture and fusion, metacarpal fracture and fusion, carpal fusion and fracture, wrist arthrodesis, distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041189 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041189: Arthrex Trimit Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041189
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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