# K972931: Plus Epf Acetabular Cup

- Pathway: 510(k) (Traditional)
- Applicant: Hhl Consulting
- Decided: Nov 13, 1997 after 97 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: 1 generation back to K961526 (1996). 1 ancestor in all.
68 later devices descend from it; 2 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)
- K961526: Press-Fit Porous Shell, Encore Orthopedics, Inc. (1996) Summary page 1.

## Most influential descendants
- K994146: Epf-Plus Cementless Press-Fit Acetabular Cup (2000), 67 descendants of its own
- 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

## Indications for use
The PLUS EPF 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. In normal cases, however, the surgeon will use an acetabular implant one size larger and in exceptional cases two sizes larger.

Source page: https://510kreport.com/device/K972931
Methodology: https://510kreport.com/methodology