# K153374: CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Orthocare
- Decided: Jun 17, 2016 after 207 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: 11 generations back to K962616 (1996). 101 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923613: Synthes Limited Contact-Dynamic Hip Screw Implant, Synthes (Usa) (1993) Summary page 7.
- K953607: Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS), Synthes (Usa) (1996) Summary page 7.
- K840954: Dynamic Condylar Screw or D.C.S., Synthes (Usa) (1984) Summary page 7.
- K092609: Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP), Synthes (Usa) (2009) Summary page 7.
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 7.
- K051986: Synthes 4.5 MM LCP Straight Reconstruction Plates, Synthes (Usa) (2005) Summary page 7.
- K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 7.
- K030597: Synthes 3.5MM Titanium LCP Proximal Tibia Plates, Synthes (Usa) (2003) Summary page 7.
- K011978: Synthes LCP Proximal Tibia Plate, Synthes (Usa) (2001) Summary page 7.
- K030858: Synthes (Usa) LCP Proximal Femur Plate and Screws, Synthes (Usa) (2003) Summary page 8.
- K033995: 3.5 MM LCP Distal Humerus System, Synthes (Usa) (2004) Summary page 8.
- K001945: Synthes (Usa) Medial Distal Tibia Plates, Synthes (Usa) (2000) Summary page 8.
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 8.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 8.
- K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 9.
- K012114: Synthes Locking Distal Radius Plating System, Synthes (Usa) (2001) Summary page 9.
- K040777: LCP Radial Head Plating System, Synthes (Usa) (2004) Summary page 9.
- K050110: Synthes (Usa) LCP Modular Foot Plates, Synthes (Usa) (2005) Summary page 9.
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 9.
- K061753: Synthes (Usa) Clavicle Hook Plates, Synthes (Usa) (2006) Summary page 9.

## Most influential descendants
- K192619: Pitkar Locked Plating System (2020), 0 descendants of its own

## Indications for use
CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System are provided non-sterile. CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are indicated 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). CARE Brand of DHS/DCS Plating 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.

Source page: https://510kreport.com/device/K153374
Methodology: https://510kreport.com/methodology