510(k) · Cleared
ClearedMetallic Locking Bone Plate and Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canwell Medical Co., Ltd. · HRS Plate, Fixation, Bone
Cleared on Aug 3, 2015 as substantially equivalent to K073159 (Trauson (Jiangsu) Medical Instrument Co., Ltd., 2008) and 3 other predicates after a 297-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Aug 3, 2015
- Review
- 297 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K962823 (1996). 41 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 6 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 5 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 4 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 3 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 2 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 1 generation backK073159 Trauson Bone Screw, Models HA 3.5 and 4.5Trauson (Jiangsu) Medical Instrument Co., Ltd. · 2008
- This deviceK142943 Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −5 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −4 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −3 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −2 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −1 | K073159 | Trauson Bone Screw, Models HA 3.5 and 4.5 | Trauson (Jiangsu) Medical Instrument Co., Ltd. | 2008 | — |
| 0 (this device) | K142943 | Metallic Locking Bone Plate and Screw | Canwell Medical Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K073159 | Trauson Bone Screw, Models HA 3.5 and 4.5Summary page 6…n, Bone (21 CFR 888.3040) ] HRS and HWC 1/3 Traditional 510(k) Submission_Metalic bone plate system Locking Bone Plates and Screws’ predicate devices: K073159, K073432, K130108 and K130009; This predicate has not been subject to a design-related recall. No reference devices were used in… | 2008 |
| * | K073432 | Trauson Bone PlateSummary page 6…21 CFR 888.3040) ] HRS and HWC 1/3 Traditional 510(k) Submission_Metalic bone plate system Locking Bone Plates and Screws’ predicate devices: K073159, K073432, K130108 and K130009; This predicate has not been subject to a design-related recall. No reference devices were used in this sub… | 2008 |
| * | K130108 | Double Engine Bone Plate and Screw SystemsSummary page 6…8.3040) ] HRS and HWC 1/3 Traditional 510(k) Submission_Metalic bone plate system Locking Bone Plates and Screws’ predicate devices: K073159, K073432, K130108 and K130009; This predicate has not been subject to a design-related recall. No reference devices were used in this submission.… | 2013 |
| * | K130009 | Variax 2 Compression Plating SystemSummary page 6…RS and HWC 1/3 Traditional 510(k) Submission_Metalic bone plate system Locking Bone Plates and Screws’ predicate devices: K073159, K073432, K130108 and K130009; This predicate has not been subject to a design-related recall. No reference devices were used in this submission. V. DEVICE DE… | 2013 |
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 19 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 5 of the 41 ancestors have a recall of any class.
- 1 other device also cites its predicate K073159.
How does its category compare?
All HRS devicesHRS Plate, 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 · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The metallic locking bone plate and screw are intended for adult patients with age above 21 as indicated fixation of fractures, including ulna, radius, humerus, femur, tibia, clavicle, and fibula for the following indications:
- osteotomies, mal-unions, and non-unions;
- single, segmental, and comminuted fractures;
- normal bone density and osteopenic bone.
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/K142943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142943: Metallic Locking Bone Plate and Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142943
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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