# K140018: TSP Hip Fracture Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Apr 4, 2014 after 91 days
- Product code: JDO (Device, Fixation, Proximal Femoral, Implant)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922322 (1992). 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)
- K813554: Ace/Kyle Captured Hip Screw, Ace Orthopedic Manufacturing Co. (1982) Summary page 1.
- K080685: Hiploc Compression Hip Screw, Biomet Manufacturing, Inc. (2008) Summary page 1.
- K972629: Depuy AE TK2 Hip Screw System, Depuy, Inc. (1997) Summary page 1.
- K082874: Biodrive Cannulated Screw System, Biomet Trauma (2009) Summary page 1.
- K092078: Optilock Periarticular Plating, Biomet Trauma (2009) Summary page 1.

## Most influential descendants
- K173826: THP Hip Fracture Plating System (2018), 0 descendants of its own

## Recalls of this device
- Jan 7, 2020 · Class II · Z-1347-2020: Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.
- Jun 10, 2016 · Class II · Z-2240-2016: The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue irritation will not oc

## Indications for use
The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures. Fracture plates with six or more femoral shaft fixation screw holes are also indicated for subtrochanteric fractures as well as proximal femoral osteotomies.

Source page: https://510kreport.com/device/K140018
Methodology: https://510kreport.com/methodology