# K023085: RX 90 Femoral Stem and RX 90 Lateralized Femoral Stem

- Pathway: 510(k) (Special)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Oct 17, 2002 after 30 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K924028: Laparoscopic Surgical Instrument, Jana Medical (1993). Our reading of the summary gave K924028, FDA’s number for Laparoscopic Surgical Instrument (Jana Medical). Its FDA name has none of the distinctive words the summary uses for the device it names, “Rx 90TM Femoral Components”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K031734: Generation 4 Polished Femoral Hip Prosthesis (2003), 12 descendants of its own
- K052639: Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement Spacer (2006), 11 descendants of its own
- K130610: Sirius Femoral Stem (2013), 10 descendants of its own
- K142295: Sirius Femoral Stem, Size 30A (2014), 9 descendants of its own
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (2018), 8 descendants of its own

## Indications for use
The indications for the Rx 90TM Femoral Stems and Rx 90TM Lateralized Femoral Stems are for 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Correction of functional deformity; 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5) Revision procedures where other treatments or devices have failed. This device is to be used with bone cement.

Source page: https://510kreport.com/device/K023085
Methodology: https://510kreport.com/methodology