510(k) · Cleared
ClearedCannulated Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HWC Screw, Fixation, Bone
Cleared on Jan 23, 2015 as substantially equivalent to K042310 (Ortho-Pro, LLC, 2004) and 1 other predicate after a 50-day review. Its family tree reaches back 2 generations to 1999. 11 later devices descend from it.
- Decided
- Jan 23, 2015
- Review
- 50 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K991151 (1999). 3 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK991151 Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex…Vilex, Inc. · 1999
- 1 generation backK042310 Ortho-Pro Cannulated Bone ScrewsOrtho-Pro, LLC · 2004
- This deviceK143460 Cannulated Screw SystemWrightmedicaltechnologyinc · 2015
- Descendant · cites it directly · 7 of its ownK180377 Fracture and Correction SystemIn2bones USA, LLC · 2018
- Descendant · cites it directly · 4 of its ownK161904 GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC · 2017
- Descendant · 2 generations on · 1 of its ownK231236 IBS-B MIS Beveled Screw SystemIn2bones USA, LLC · 2023
- Descendant · 2 generations on · 1 of its ownK202817 GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK201430 InFrame™ Cannulated Fixation SystemExsomed Corp. · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K180377Fracture and Correction SystemIn2bones USA, LLC · 2018 · cites it directly7descendants
- K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC · 2017 · cites it directly4descendants
- K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC · 2023 · 2 generations on1descendant
- K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC · 2020 · 2 generations on1descendant
- K201430InFrame™ Cannulated Fixation SystemExsomed Corp. · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991151 | Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated… | Vilex, Inc. | 1999 | — |
| −1 | K042310 | Ortho-Pro Cannulated Bone Screws | Ortho-Pro, LLC | 2004 | — |
| 0 (this device) | K143460 | Cannulated Screw System | Wrightmedicaltechnologyinc | 2015 | — |
| +1 | K180377 | Fracture and Correction System | In2bones USA, LLC | 2018 | — |
| +1 | K161904 | GEO Bone Screw System | Gramercy Extremity Orthopeidics, LLC | 2017 | — |
| +2 | K231236 | IBS-B MIS Beveled Screw System | In2bones USA, LLC | 2023 | — |
| +2 | K202817 | GEO Bone Screw System | Gramercy Extremity Orthopedics, LLC | 2020 | — |
| +2 | K201430 | InFrame™ Cannulated Fixation System | Exsomed Corp. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K042310 | Ortho-Pro Cannulated Bone ScrewsSummary page 4…21 CFR 888.3040 – Class II Device Product Code, Device Panel: HWC – Orthopedic (a)(3). Predicate Device: K042310: Cannulated Bone Screws System K082320: Wright Compression Screws (a)(4).… | 2004 |
| * | K082320 | Darco Small ScrewSummary page 4…HWC – Orthopedic (a)(3). Predicate Device: K042310: Cannulated Bone Screws System K082320: Wright Compression Screws (a)(4). Device Description The Cannulated Screw System implants are partially threaded devices… | 2008 |
What descends from it? (11)
See all 112 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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 10.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K180377 (In2bones USA, LLC, 2018) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K042310.
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 CSS cannulated bone screw is indicated for bone fractures, osteotomies, arthodeses, osteochronditis and tendon reattachment. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of cervical, thoracic, or lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143460: Cannulated 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/K143460
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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