# K141680: AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws

- Pathway: 510(k) (Traditional)
- Applicant: Auxein Medical
- Decided: Jun 30, 2015 after 372 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: 5 generations back to K981372 (1998). 33 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012114: Synthes Locking Distal Radius Plating System, Synthes (Usa) (2001) Summary page 7.
- K040777: LCP Radial Head Plating System, Synthes (Usa) (2004) Summary page 7.
- K033995: 3.5 MM LCP Distal Humerus System, Synthes (Usa) (2004) Summary page 7.
- K001945: Synthes (Usa) Medial Distal Tibia Plates, Synthes (Usa) (2000) Summary page 7.
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 7.
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 8.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 8.
- K030597: Synthes 3.5MM Titanium LCP Proximal Tibia Plates, Synthes (Usa) (2003) Summary page 8.
- K011978: Synthes LCP Proximal Tibia Plate, Synthes (Usa) (2001) Summary page 8.
- K092812: Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates, Synthes (Usa) (2010) Summary page 8.
- K061753: Synthes (Usa) Clavicle Hook Plates, Synthes (Usa) (2006) Summary page 8.
- K092609: Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP), Synthes (Usa) (2009) Summary page 9.
- K051986: Synthes 4.5 MM LCP Straight Reconstruction Plates, Synthes (Usa) (2005) Summary page 9.
- K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 9.
- K030858: Synthes (Usa) LCP Proximal Femur Plate and Screws, Synthes (Usa) (2003) Summary page 9.
- K033975: Synthes 2.4 MM Titanium (TI.) Locking Screws, Synthes (Usa) (2004) Summary page 9.
- K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 9.

## Most influential descendants
- K201510: Traufix osteosynthesis, osteotomy, and arthrodesis devices (2022), 0 descendants of its own

## Indications for use
AUXEIN Brand of Bone plates and bone screws are provided non-sterile. AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System, AUXEIN brand of Locking Plates and Locking Screws. AUXEIN Brand of Bone plates and bone screws are provided non-sterile. AUXEIN Brand of bone plates and bone screws are intended for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus,ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges). AUXEIN Brand of DCS plate system is used to provide fixation of fractures to the proximal femur shaft and generally indicated for use in trochanteric, pertrochanteric, intertrochanteric fractures. The system is indicated for use in adult patients only. All implants are for single use only. AUXEIN brand of Locking Plates and Locking screws have the same indications for use as mentioned above with additional feature of locking by way of combination threads in plates and corresponding Screws.

Source page: https://510kreport.com/device/K141680
Methodology: https://510kreport.com/methodology