510(k) · Cleared
ClearedLocking Bone Plates and Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Weigao Orthopaedic Device Co., Ltd. · HRS Plate, Fixation, Bone
Cleared on Apr 5, 2013 as substantially equivalent to K101400 (Changzhou Orthmed Medical Instrument Co., Ltd., 2010) and 1 other predicate after a 53-day review. Its family tree reaches back 7 generations to 1998. 7 later devices descend from it.
- Decided
- Apr 5, 2013
- Review
- 53 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K981372 (1998). 16 ancestors in all. 7 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 6 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 5 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 4 generations backK050457 Merete Metafix Small Fragment Bone Plate SystemMerete Medical GmbH · 2005
- 3 generations backK063487 Merete BLP Small Fragment Locking Bone PlateMerete Medical GmbH · 2007
- 2 generations backK081513 Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH · 2008
- 1 generation backK100721 Locking Bone Screw Model HCQ04, HCZ04Changzhou Orthmar Medical Instrument Co., Ltd. · 2010
- This deviceK130340 Locking Bone Plates and ScrewsWeigao Orthopaedic Device Co., Ltd. · 2013
- Descendant · cites it directly · 2 of its ownK133840 Kangli Locking Plate SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK143002 Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK150009 BaideJiangsu Baide Medical Intrument Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK240958 Locking Plates and Screws SystemsHebei Ruihe Medical Devices Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK190842 Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd. · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K133840Kangli Locking Plate SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd. · 2014 · cites it directly2descendants
- K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd. · 2015 · cites it directly1descendant
- K150009BaideJiangsu Baide Medical Intrument Co., Ltd. · 2015 · cites it directly1descendant
- K240958Locking Plates and Screws SystemsHebei Ruihe Medical Devices Co., Ltd. · 2025 · 2 generations on0descendants
- K190842Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −6 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −5 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −4 | K050457 | Merete Metafix Small Fragment Bone Plate System | Merete Medical GmbH | 2005 | — |
| −3 | K063487 | Merete BLP Small Fragment Locking Bone Plate | Merete Medical GmbH | 2007 | — |
| −2 | K081513 | Merete 3.0 and 3.5 MM Locking Screws | Merete Medical GmbH | 2008 | — |
| −1 | K100721 | Locking Bone Screw Model HCQ04, HCZ04 | Changzhou Orthmar Medical Instrument Co., Ltd. | 2010 | — |
| 0 (this device) | K130340 | Locking Bone Plates and Screws | Weigao Orthopaedic Device Co., Ltd. | 2013 | — |
| +1 | K133840 | Kangli Locking Plate System | Suzhou Kangli Orthopaedics Instrument Co., Ltd. | 2014 | — |
| +1 | K143002 | Metallic Locking Bone Plate and Screw System | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015 | — |
| +1 | K150009 | Baide | Jiangsu Baide Medical Intrument Co., Ltd. | 2015 | — |
| +2 | K240958 | Locking Plates and Screws Systems | Hebei Ruihe Medical Devices Co., Ltd. | 2025 | — |
| +2 | K190842 | Comus Locking Plate systems | Jiangsu Trauhui Medical Instrument Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K101400 | Locking Compression PlateSummary page 2…age above 21 as indicated for. fixation of fractures, including ulna. radius, humerus, femur and tibia. 5. Predicate Device Identification 510(k) Number: K 10 1400 Product Name: Locking Compression Plate Manufacturer: Changzhou Orihmed Medical Instrument Co., Ltd 510(k) Numbe… | 2010 |
| * | K100721 | Locking Bone Screw Model HCQ04, HCZ04Summary page 2…ation 510(k) Number: K 10 1400 Product Name: Locking Compression Plate Manufacturer: Changzhou Orihmed Medical Instrument Co., Ltd 510(k) Number: K 100721 Product Name: Locking Bone Screw Manufacturer: Changzhuu Orthined Medical Instrument Co.. Ltd 6. IDevice D~escripti… | 2010 |
What descends from it? (7)
5 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 15 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 16 ancestors have a recall of any class.
- Of its descendants, K133840 (Suzhou Kangli Orthopaedics Instrument Co., Ltd., 2014) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K101400.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Locking Bone Plates and Screws are intended for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130340 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130340: Locking Bone Plates and Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130340
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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