# K011719: Plus Cancellous Bone Screws

- Pathway: 510(k) (Special)
- Applicant: Plus Orthopedics
- Decided: Jul 2, 2001 after 28 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K903362 (1990). 10 ancestors in all.
63 later devices descend from it; 4 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993874: Bofor Revision Coup, Plus Orthopedics (2000) Summary page 1.
- K994146: Epf-Plus Cementless Press-Fit Acetabular Cup, Plus Orthopedics (2000) Summary page 1.

## Most influential descendants
- K123055: Smith & Nephew, Inc Screw and Plate System Instrumentation (2013), 33 descendants of its own
- K140814: Evos Mini-Fragment Plating System (2014), 32 descendants of its own
- K091069: Medacta Bone Screws - Evolis and Versafit (2009), 23 descendants of its own
- K103721: Mpact Acetabular System (2011), 21 descendants of its own
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own

## Indications for use
The PLUS Cancellous Bone Screws are intended as a bone fixation device for a variety of surgical applications, such as fixation of press-fit acetabular cups in total hip arthroplasty or acetabular revisions, tibial components in total knee arthroplasty of knee revisions, and fixation of small and long bone fractures. WARNING: These cancellous bone screws are not intended for spinal fixation.

Source page: https://510kreport.com/device/K011719
Methodology: https://510kreport.com/methodology