510(k) · Cleared
ClearedMedline UNITE Jones Fracture Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industires, Inc. · HWC Screw, Fixation, Bone
Cleared on Jun 17, 2020 as substantially equivalent to K130319 (Medline Industries, Inc., 2013) and 1 other predicate after a 30-day review. Its family tree reaches back 3 generations to 2006.
- Decided
- Jun 17, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K053136 (2006). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK053136 5TH Metatarsal Fracture ScrewWrightmedicaltechnologyinc · 2006
- 2 generations backK140952 Charlotte Carolina Jones Fracture System ScrewWrightmedicaltechnologyinc · 2014
- 1 generation backK183026 Wright Jones Fracture SystemWrightmedicaltechnologyinc · 2019
- This deviceK201319 Medline UNITE Jones Fracture Screw SystemMedline Industires, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K053136 | 5TH Metatarsal Fracture Screw | Wrightmedicaltechnologyinc | 2006 | — |
| −2 | K140952 | Charlotte Carolina Jones Fracture System Screw | Wrightmedicaltechnologyinc | 2014 | — |
| −1 | K183026 | Wright Jones Fracture System | Wrightmedicaltechnologyinc | 2019 | — |
| 0 (this device) | K201319 | Medline UNITE Jones Fracture Screw System | Medline Industires, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 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? (2)
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 |
|---|---|---|---|
| * | K130319 | Medline Cannulated ScrewSummary page 4…tion fastener Product Code: HWC, HTN Classification Panel: Orthopedics Regulatory Class: II Regulation #: 21 CFR 888.3040 (Primary) and 21 CFR 888.3030 Predicate Device K130319 – Medline Cannulated Screw (Primary) K183026 – Wright Jones Fracture System… | 2013 |
| * | K183026 | Wright Jones Fracture SystemSummary page 4…cation Panel: Orthopedics Regulatory Class: II Regulation #: 21 CFR 888.3040 (Primary) and 21 CFR 888.3030 Predicate Device K130319 – Medline Cannulated Screw (Primary) K183026 – Wright Jones Fracture System… | 2019 |
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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- None of the 5 ancestors has a recall.
- 8 other devices also cite its predicate K130319.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Medline UNITE® Jones Fracture Screws are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion and repair and fixation of mal-unions, non-unions, acute fractures, avulsion fractures, and repetitive stress fractures for bones appropriate for the size of the device including the fifth metatarsal (Jones fracture). Screws are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201319: Medline UNITE Jones Fracture 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/K201319
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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