# K993874: Bofor Revision Coup

- Pathway: 510(k) (Traditional)
- Applicant: Plus Orthopedics
- Decided: Jun 5, 2000 after 203 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- 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 K903362 (1990). 6 ancestors in all.
65 later devices descend from it; 2 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971854: Osteolock Acetabular Shell System, Howmedica Corp. (1997) Summary page 1.
- K981201: Osteolock Acetabular Cup, Howmedica Corp. (1998) 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 BOFOR Revision Cup is intended to be used to replace the acetabulum in revision hip arthroplasty.

Source page: https://510kreport.com/device/K993874
Methodology: https://510kreport.com/methodology