510(k) · Cleared
ClearedLocking Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Keyi Medical Device Technology Co., Ltd. · HRS Plate, Fixation, Bone
Cleared on May 2, 2017 as substantially equivalent to K101400 (Changzhou Orthmed Medical Instrument Co., Ltd., 2010) and 2 other predicates after a 251-day review. Its family tree reaches back 8 generations to 1998.
- Decided
- May 2, 2017
- Review
- 251 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K981372 (1998). 17 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK162380 Locking Plate SystemBeijing Keyi Medical Device Technology Co., Ltd. · 2017
View 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) | K162380 | Locking Plate System | Beijing Keyi Medical Device Technology Co., Ltd. | 2017 | — |
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 |
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? (3)
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 6…Ref.:M0022014 5. Identification of Predicate Devices Primary Predicate 510(k) Number: K101400 Product Name: Locking Compression Plate Manufacturer: Changzhou Orthmed Medical Instrument Co., Ltd. Additional… | 2010 |
| * | K100721 | Locking Bone Screw Model HCQ04, HCZ04Summary page 6…r: K101400 Product Name: Locking Compression Plate Manufacturer: Changzhou Orthmed Medical Instrument Co., Ltd. Additional Predicate 510(k) Number: K100721 Product Name: Locking Bone Screw Manufacturer: Changzhou Orthmed Medical Instrument Co., Ltd. Additional Predica… | 2010 |
| * | K130340 | Locking Bone Plates and ScrewsSummary page 6…) Number: K100721 Product Name: Locking Bone Screw Manufacturer: Changzhou Orthmed Medical Instrument Co., Ltd. Additional Predicate 510(k) Number: K130340 Product Name: Locking Bone Plates and Screws Manufacturer: Weigao Orthopaedic Device Co., Ltd. 6. Non-Clinical Test… | 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 2.3 years on median.
- 4 of the 17 ancestors have a recall of any class.
- 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. 2017, 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 Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur, tibia and fibula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162380 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162380: 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/K162380
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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