510(k) · Cleared
ClearedDouble Engine Bone Plate and Screw Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xiamen Double Engine Medical Material Co., Ltd. · HRS Plate, Fixation, Bone
Cleared on Apr 19, 2013 as substantially equivalent to K010766 (Synthes (Usa), 2001) and 5 other predicates after a 93-day review. Its family tree reaches back 2 generations to 1998. 9 later devices descend from it.
- Decided
- Apr 19, 2013
- Review
- 93 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 2 generations to K983495 (1998). 7 ancestors in all, the oldest K963192 (1996). 9 later devices descend from it, 9 citing it directly.
- Root · 2 generations backK983495 Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S…Syntec Scientific Corp. · 1998
- 1 generation backK092889 Syntec Osteo-Plate and Screw FixationSyntec Scientific Corp. · 2010
- This deviceK130108 Double Engine Bone Plate and Screw SystemsXiamen Double Engine Medical Material Co., Ltd. · 2013
- Descendant · cites it directly · 1 of its ownK221150 Advanced Bone PlateDouble Medical Technology, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK221088 Anatomic Bone PlateDouble Medical Technology, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK220921 Metal Bone ScrewDouble Medical Technology, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK242973 CanMINI Hand and Foot SystemCanwell Medical Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK240958 Locking Plates and Screws SystemsHebei Ruihe Medical Devices Co., Ltd. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K221150Advanced Bone PlateDouble Medical Technology, Inc. · 2023 · cites it directly1descendant
- K221088Anatomic Bone PlateDouble Medical Technology, Inc. · 2023 · cites it directly1descendant
- K220921Metal Bone ScrewDouble Medical Technology, Inc. · 2022 · cites it directly1descendant
- K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd. · 2025 · cites it directly0descendants
- K240958Locking Plates and Screws SystemsHebei Ruihe Medical Devices Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983495 | Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S… | Syntec Scientific Corp. | 1998 | — |
| −1 | K092889 | Syntec Osteo-Plate and Screw Fixation | Syntec Scientific Corp. | 2010 | — |
| 0 (this device) | K130108 | Double Engine Bone Plate and Screw Systems | Xiamen Double Engine Medical Material Co., Ltd. | 2013 | — |
| +1 | K221150 | Advanced Bone Plate | Double Medical Technology, Inc. | 2023 | — |
| +1 | K221088 | Anatomic Bone Plate | Double Medical Technology, Inc. | 2023 | — |
| +1 | K220921 | Metal Bone Screw | Double Medical Technology, Inc. | 2022 | — |
| +1 | K242973 | CanMINI Hand and Foot System | Canwell Medical Co., Ltd. | 2025 | — |
| +1 | 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 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010766 | Synthes (Usa) Large Fragment Locking Compression Plate (LCP) System-T Plate | 2001 |
| * | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, LongSummary page 3…_______________System-TPlate Synthes (USA)LCP Proximal S mall 7-K04 1860 Synthes (USA) Humerus Plate, Long Mini… | 2004 |
| Kept off the family tree | K06049 | Modular Mini Fragment LCP System Number could not be read Summary page 3…roximal S mall 7-K04 1860 Synthes (USA) Humerus Plate, Long Mini K06049 yntes (SA) Synthes (tJSA)Modular Mini Mini K06049… | |
| * | K092889 | Syntec Osteo-Plate and Screw FixationSummary page 3…yntes (SA)Fragment LCP System -Syntec Scientific Syntec Osteo Plate and Screw Reconstruction' K092889 Corporation Fixation Table 3.6.2 Information of the predicate screws us… | 2010 |
| * | K043185 | Synthes 3.5MM Cortex ScrewsSummary page 3…predicate screws used in this Submission Predicate Set- K No., Company Name Device Name Cortex K043 185 Synthes (USA) Synthes 3.5mmn Cortex Screws Cancellous K061621 Synthes (USA… | 2005 |
| * | K061621 | Synthes (Usa) 6.5 MM Cancellous ScrewsSummary page 3…Device Name Cortex K043 185 Synthes (USA) Synthes 3.5mmn Cortex Screws Cancellous K061621 Synthes (USA) Syte(UA6.mmCneou… | 2006 |
| * | K963192 | Synthes Sterile 3.5 MM and 4.0 MM Cannulated ScrewsSummary page 3…Screws Synthes Sterile 3.5mm and 4.0 mm Cannulated K963 192 ISynthes (USA) Cannulated Screws 3.6 Non-Clinical Tests Conclusion Non-clinical tests inclu… | 1996 |
What descends from it? (9)
9 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221150 | Advanced Bone Plate | 2023 | 1 |
| K221088 | Anatomic Bone Plate | 2023 | 1 |
| K220921 | Metal Bone Screw | 2022 | 1 |
| K242973 | CanMINI Hand and Foot System | 2025 | 0 |
| K240958 | Locking Plates and Screws Systems | 2025 | 0 |
| K242348 | Locking Screw,CoCrMo | 2024 | 0 |
| K221090 | Metal Cannulated Screw | 2023 | 0 |
| K142943 | Metallic Locking Bone Plate and Screw | 2015 | 0 |
| K141825 | IDEAL Locking Plate System | 2015 | 0 |
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 2 companies; a new generation was cleared every 11.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K221150 (Double Medical Technology, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K010766.
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?
Double Engine Bone Plate and Screw Systems are provided non-sterile. Double Engine Bone Plate and Screw Systems are intended for fixation of various bone fracture, including large bone (clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and phalanges).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130108 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130108: Double Engine Bone Plate and Screw Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130108
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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