510(k) · Cleared
ClearedTrauson Bone Screw, Models HA 3.5 and 4.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trauson (Jiangsu) Medical Instrument Co., Ltd. · HWC Screw, Fixation, Bone
Cleared on Jul 23, 2008 as substantially equivalent to K060071 (Nexa Orthopedics, Inc., 2006) after a 258-day review. Its family tree reaches back 5 generations to 1996. 3 later devices descend from it.
- Decided
- Jul 23, 2008
- Review
- 258 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K962823 (1996). 12 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 4 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 3 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 2 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 1 generation backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- This deviceK073159 Trauson Bone Screw, Models HA 3.5 and 4.5Trauson (Jiangsu) Medical Instrument Co., Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK131759 Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK142943 Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK133525 Locking Compression Bone Plates and Screw SystemChangzhou Dean Medical Instrument Co, Ltd. · 2014
Most influential descendants
Showing 3 of 3 · See all- K131759Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd. · 2013 · cites it directly1descendant
- K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd. · 2015 · cites it directly0descendants
- K133525Locking Compression Bone Plates and Screw SystemChangzhou Dean Medical Instrument Co, Ltd. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −4 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −3 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −2 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −1 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| 0 (this device) | K073159 | Trauson Bone Screw, Models HA 3.5 and 4.5 | Trauson (Jiangsu) Medical Instrument Co., Ltd. | 2008 | — |
| +1 | K131759 | Metallic Locking Compression Bone Plates and Screws System | Tianjin Walkman Biomaterial Co., Ltd. | 2013 | — |
| +1 | K142943 | Metallic Locking Bone Plate and Screw | Canwell Medical Co., Ltd. | 2015 | — |
| +2 | K133525 | Locking Compression Bone Plates and Screw System | Changzhou Dean Medical Instrument Co, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K060071 | Nexa Compression ScrewSummary page 2…X I Premarket Notification 510(k) Submission-5 10(k) Summary Report No.: A20060011 3. Predicate Device K-number: K060071 Device Name: Nexa Compression Screw Device Trade Name: Nexa Compression Screw Manufactured by: Nexa Orth… | 2006 |
What descends from it? (3)
2 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 12 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K131759 (Tianjin Walkman Biomaterial Co., Ltd., 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K060071.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Trauson Bone Screw is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073159: Trauson Bone Screw, Models HA 3.5 and 4.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073159
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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