# K994146: Epf-Plus Cementless Press-Fit Acetabular Cup

- Pathway: 510(k) (Traditional)
- Applicant: Plus Orthopedics
- Decided: Dec 11, 2000 after 369 days
- Product code: LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)
- 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: 2 generations back to K961526 (1996). 2 ancestors in all.
67 later devices descend from it; 3 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972931: Plus Epf Acetabular Cup, Hhl Consulting (1997) Summary page 1.

## Most influential descendants
- K011719: Plus Cancellous Bone Screws (2001), 63 descendants of its own
- 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

## Indications for use
The EPF®-PLUS Cementless Press-Fit Acetabular Cup is intended for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.

Source page: https://510kreport.com/device/K994146
Methodology: https://510kreport.com/methodology
