# K972228: Meridian Titanium Femoral Stems

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica, Inc.
- Decided: Dec 5, 1997 after 175 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: 1 generation back to K941141 (1994). 3 ancestors in all.
255 later devices descend from it; 5 cite it directly.
0 of 259 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940307: Howmedica Straight Stem Femoral Component, Howmedica, Inc. (1995) Summary page 1.
- K944592: Precision Osteolock Femoral Component, Howmedica Corp. (1995) Summary page 1.
- K941141: Precision Ostelock  SP Femoral Component, Howmedica Corp. (1994) Summary page 1.
- (no number) Osteonics' Arc Deposition Hip Components: named in the summary without a submission number

## Most influential descendants
- K993768: Citation TMZF HA Stem (2000), 224 descendants of its own
- K001448: Trident Acetabular Shells: PS-HA (2000), 150 descendants of its own
- K013106: 2 Piece Modular Hip Stem (2002), 101 descendants of its own
- K060437: Excia Total Hip System with U-Cap (2006), 90 descendants of its own
- K080584: Metha Short Stem Hip System (2008), 83 descendants of its own

## Indications for use
The Meridian® Titanium Femoral Components consist of a family of Titanium femoral stems with Titanium plasma spray coating that are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components in primary or revision total hip arthroplasty. These femoral stems are designed to be press fit into the proximal femur. They do not achieve fixation by biological ingrowth.

Source page: https://510kreport.com/device/K972228
Methodology: https://510kreport.com/methodology