# K130108: Double Engine Bone Plate and Screw Systems

- Pathway: 510(k) (Traditional)
- Applicant: Xiamen Double Engine Medical Material Co., Ltd.
- Decided: Apr 19, 2013 after 93 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983495 (1998). 7 ancestors in all.
9 later devices descend from it; 9 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010766: Synthes (Usa) Large Fragment Locking Compression Plate (LCP) System-T Plate, Synthes (Usa) (2001)
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 3.
- K092889: Syntec Osteo-Plate and Screw Fixation, Syntec Scientific Corp. (2010) Summary page 3.
- K043185: Synthes 3.5MM Cortex Screws, Synthes (Usa) (2005) Summary page 3.
- K061621: Synthes (Usa) 6.5 MM Cancellous Screws, Synthes (Usa) (2006) Summary page 3.
- K963192: Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 3.

## Cited in the summary but kept off the family tree
- K06049: Modular Mini Fragment LCP System. Number could not be read Summary page 3.

## Most influential descendants
- K221150: Advanced Bone Plate (2023), 1 descendant of its own
- K221088: Anatomic Bone Plate (2023), 1 descendant of its own
- K220921: Metal Bone Screw (2022), 1 descendant of its own
- K242973: CanMINI Hand and Foot System (2025), 0 descendants of its own
- K240958: Locking Plates and Screws Systems (2025), 0 descendants of its own

## Indications for use
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).

Source page: https://510kreport.com/device/K130108
Methodology: https://510kreport.com/methodology