# K961890: Foundation 9MM Forged Cemented Stem

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Jun 14, 1996 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952191 (1995). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952191: Forged Cemented Stem, Encore Orthopedics, Inc. (1995) Summary page 2.

## Most influential descendants
- K991227: 8MM Forged Cemented Stem (1999), 3 descendants of its own
- K031165: Plus Orthopedics Cemented Hip Stem (2003), 1 descendant of its own
- K123598: Smith & Nephew, Inc. Hip System Instrumentation (2013), 0 descendants of its own
- K121024: Linear Porous Coated Hip Stem, Size 5; Revelation Hip Stem, Size 8; Foundation Porous Press Fit Stem, Size 8; (2012), 0 descendants of its own
- K962560: Vitality Hip Stem (1996), 0 descendants of its own

## Recalls of this device
- Aug 17, 2011 · Not classified · Z-0418-2012: The sterility has the potential to be compromised.

## Indications for use
The Foundation 9 mm Forged Cemented Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty. The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments where devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. It is intended to be used with cement with acetabular components or with unipolar heads.

Source page: https://510kreport.com/device/K961890
Methodology: https://510kreport.com/methodology