# K990309: Plus Fracture Head Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Plus Orthopedics
- Decided: Mar 15, 1999 after 42 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K965156 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965156: Ultima*Unipolar Head and Adapter Sleeves, Johnson & Johnson Professionals, Inc. (1997) Summary page 1.
- K973614: Foundation Unipolar Femoral Head with Modular Neck Length Sleeves, Encore Orthopedics, Inc. (1997) Summary page 1.

## Most influential descendants
- K123598: Smith & Nephew, Inc. Hip System Instrumentation (2013), 0 descendants of its own

## Indications for use
The PLUS Fracture Head Prosthesis is intended for use in fractures of the femoral neck and fractures or avascular necrosis of the femoral head with all PLUS hip stem prostheses, which have the appropriate 12/14 Morse Taper.

Source page: https://510kreport.com/device/K990309
Methodology: https://510kreport.com/methodology