510(k) · Cleared
ClearedArthrex RetroFusion Screw
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 May 15, 2015 as substantially equivalent to K050259 (Arthrex, Inc., 2005) after a 23-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- May 15, 2015
- Review
- 23 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K050259 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK050259 Arthrex Bio-PinArthrex, Inc. · 2005
- This deviceK151078 Arthrex RetroFusion ScrewArthrex, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050259 | Arthrex Bio-Pin | Arthrex, Inc. | 2005 | — |
| 0 (this device) | K151078 | Arthrex RetroFusion Screw | Arthrex, Inc. | 2015 | — |
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? (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 |
|---|---|---|---|
| * | K050259 | Arthrex Bio-PinSummary page 4…CFR fixation fastener Predicate Device K050259: Arthrex Bio-Pin Purpose of Submission This special… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 15 other devices also cite its predicate K050259.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 RetroFusion Screw is intended to fix small bony or apical chondral fragments in the foot, ankle, upper extremities, hand, and wrist, where such fragments are not under tension or load-bearing. These devices are used in cases of osteochondritis dissecans and osteochondral fragments, fixation of fractures, 1st metatarsal (bunionectomy osteotomies), cuneiform bones, inherently stable osteotomies, and fusions of the phalanges, metatarsals…
Read the full statement (124 words)
The Arthrex RetroFusion Screw is intended to fix small bony or apical chondral fragments in the foot, ankle, upper extremities, hand, and wrist, where such fragments are not under tension or load-bearing. These devices are used in cases of osteochondritis dissecans and osteochondral fragments, fixation of fractures, 1st metatarsal (bunionectomy osteotomies), cuneiform bones, inherently stable osteotomies, and fusions of the phalanges, metatarsals, metacarpals, carpal bones, tarsal bones, ankle, and wrist. The devices can be used for inherently stable intramedullary stabilization of joint arthroplasty (resection) or fusion for the treatment of digital deformities of the foot or hand. This device is also used in inherently stable long bone fractures such as the femur, fibula, tibia, radius and ulna, including the diaphyseal, epiphyseal, and metaphyseal areas.
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/K151078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151078: Arthrex RetroFusion Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151078
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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