510(k) · Cleared
ClearedKangli Locking Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Kangli Orthopaedics Instrument Co., Ltd. · HRS Plate, Fixation, Bone
Cleared on Jul 29, 2014 as substantially equivalent to K130340 (Weigao Orthopaedic Device Co., Ltd., 2013) after a 223-day review. Its family tree reaches back 8 generations to 1998. 2 later devices descend from it.
- Decided
- Jul 29, 2014
- Review
- 223 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K981372 (1998). 17 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 7 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 6 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 5 generations backK050457 Merete Metafix Small Fragment Bone Plate SystemMerete Medical GmbH · 2005
- 4 generations backK063487 Merete BLP Small Fragment Locking Bone PlateMerete Medical GmbH · 2007
- 3 generations backK081513 Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH · 2008
- 2 generations backK100721 Locking Bone Screw Model HCQ04, HCZ04Changzhou Orthmar Medical Instrument Co., Ltd. · 2010
- 1 generation backK130340 Locking Bone Plates and ScrewsWeigao Orthopaedic Device Co., Ltd. · 2013
- This deviceK133840 Kangli Locking Plate SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd. · 2014
- 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
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −7 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −6 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −5 | K050457 | Merete Metafix Small Fragment Bone Plate System | Merete Medical GmbH | 2005 | — |
| −4 | K063487 | Merete BLP Small Fragment Locking Bone Plate | Merete Medical GmbH | 2007 | — |
| −3 | K081513 | Merete 3.0 and 3.5 MM Locking Screws | Merete Medical GmbH | 2008 | — |
| −2 | K100721 | Locking Bone Screw Model HCQ04, HCZ04 | Changzhou Orthmar Medical Instrument Co., Ltd. | 2010 | — |
| −1 | K130340 | Locking Bone Plates and Screws | Weigao Orthopaedic Device Co., Ltd. | 2013 | — |
| 0 (this device) | K133840 | Kangli Locking Plate System | Suzhou Kangli Orthopaedics Instrument Co., Ltd. | 2014 | — |
| +1 | K150009 | Baide | Jiangsu Baide Medical Intrument Co., Ltd. | 2015 | — |
| +2 | K240958 | Locking Plates and Screws Systems | Hebei Ruihe Medical Devices Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 2015 | 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? (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 |
|---|---|---|---|
| * | K130340 | Locking Bone Plates and ScrewsSummary page 1…Fixation, Bone Device Class: Class 11 Classification Panel: Orthopedic Pane! Product Code: HWC Regulation Number: 21 CFR 888.3040 4. Predicate Devices 510 (k) Number: K1 30340 Product Name: Locking Bone Plates and Scews Submitter: Weigao Orthopaedlic Device Co., Ltd. 5. Device Description === Page 2… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150009 | Baide | 2015 | 1 |
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 6 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 17 ancestors have a recall of any class.
- Of its descendants, K150009 (Jiangsu Baide Medical Intrument Co., Ltd., 2015) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K130340.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
KangLi® locking plate system is intended for adult patients as indicated for fixation of fractures of tibia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133840 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133840: Kangli Locking Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133840
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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