# K991227: 8MM Forged Cemented Stem

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Jun 1, 1999 after 50 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
Longest line of descent: 2 generations back to K952191 (1995). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961890: Foundation 9MM Forged Cemented Stem, Encore Orthopedics, Inc. (1996). Our OCR of the scanned summary read K961809, FDA’s number for She-LI Tens Stimulator Model SL-101 RX (Medi Consultants, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “9mm Forged Cemented Stem”.

## Most influential descendants
- 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

## Indications for use
The indications for use of the Foundation 8mm cemented total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or 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

Source page: https://510kreport.com/device/K991227
Methodology: https://510kreport.com/methodology