510(k) · Cleared
ClearedLocking Plates and Screws Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hebei Ruihe Medical Devices Co., Ltd. · HRS Plate, Fixation, Bone
Cleared on Feb 10, 2025 as substantially equivalent to K150009 (Jiangsu Baide Medical Intrument Co., Ltd., 2015) and 1 other predicate after a 308-day review. Its family tree reaches back 10 generations to 1998.
- Decided
- Feb 10, 2025
- Review
- 308 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K981372 (1998). 27 ancestors in all, the oldest K963192 (1996). No later device cites it as a predicate yet.
- Root · 10 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 6 generations between
- 3 generations backK130340 Locking Bone Plates and ScrewsWeigao Orthopaedic Device Co., Ltd. · 2013
- 2 generations backK133840 Kangli Locking Plate SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd. · 2014
- 1 generation backK150009 BaideJiangsu Baide Medical Intrument Co., Ltd. · 2015
- This deviceK240958 Locking Plates and Screws SystemsHebei Ruihe Medical Devices Co., Ltd. · 2025
Show all 10 generations
- Root · 10 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 9 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 8 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 7 generations backK050457 Merete Metafix Small Fragment Bone Plate SystemMerete Medical GmbH · 2005
- 6 generations backK063487 Merete BLP Small Fragment Locking Bone PlateMerete Medical GmbH · 2007
- 5 generations backK081513 Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH · 2008
- 4 generations backK100721 Locking Bone Screw Model HCQ04, HCZ04Changzhou Orthmar Medical Instrument Co., Ltd. · 2010
- 3 generations backK130340 Locking Bone Plates and ScrewsWeigao Orthopaedic Device Co., Ltd. · 2013
- 2 generations backK133840 Kangli Locking Plate SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd. · 2014
- 1 generation backK150009 BaideJiangsu Baide Medical Intrument Co., Ltd. · 2015
- This deviceK240958 Locking Plates and Screws SystemsHebei Ruihe Medical Devices Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −9 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −8 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −7 | K050457 | Merete Metafix Small Fragment Bone Plate System | Merete Medical GmbH | 2005 | — |
| −6 | K063487 | Merete BLP Small Fragment Locking Bone Plate | Merete Medical GmbH | 2007 | — |
| −5 | K081513 | Merete 3.0 and 3.5 MM Locking Screws | Merete Medical GmbH | 2008 | — |
| −4 | K100721 | Locking Bone Screw Model HCQ04, HCZ04 | Changzhou Orthmar Medical Instrument Co., Ltd. | 2010 | — |
| −3 | K130340 | Locking Bone Plates and Screws | Weigao Orthopaedic Device Co., Ltd. | 2013 | — |
| −2 | K133840 | Kangli Locking Plate System | Suzhou Kangli Orthopaedics Instrument Co., Ltd. | 2014 | — |
| −1 | K150009 | Baide | Jiangsu Baide Medical Intrument Co., Ltd. | 2015 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 2 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K150009 | BaideSummary page 5…ate Devices(s) [21 CFR 807.92(a)(3)] The identification of predicates within this submission is as follows: Predicate Devices #1 (Primary): 510 (k) Number: K150009 Product Name: BaiDe® Locking Plate System Submitter: Jiangsu BaiDe Medical Instrument Co. Ltd. Predicate Devices #… | 2015 |
| * | K130108 | Double Engine Bone Plate and Screw SystemsSummary page 5…) Number: K150009 Product Name: BaiDe® Locking Plate System Submitter: Jiangsu BaiDe Medical Instrument Co. Ltd. Predicate Devices #2: 510 (k) Number: K130108 K240958 - Page 1 of 7 Product… | 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 27 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 27 ancestors have a recall of any class.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Plates and Screws Systems is intended to provide fixation during fractures, fusions, and osteotomies. Locking Plates and Screws Systems is indicated for the clavicle, and small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240958 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240958: Locking Plates and Screws Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240958
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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