# K971206: Meridian ST Femoral Stem and Vitalock Solid Back Shell W/ Peri-Apatite Coating

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Feb 11, 1998 after 336 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
255 later devices descend from it; 5 cite it directly.
0 of 256 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Meridian™ ST Femoral Stem: named in the summary without a submission number
- (no number) Vitalock® Solid Backed Acetabular Shell: named in the summary without a submission number
- (no number) Osteolock™ HA Femoral Stem: named in the summary without a submission number

## Most influential descendants
- K013475: Trident Porous Titanium Acetabular Component with Peri-Apatite Coating (2001), 216 descendants of its own
- K042344: Excia Total Hip System (2005), 198 descendants of its own
- K060918: Excia Total Hip System 12/14 Trunnion with Ceramic Head (2006), 90 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

## Recalls of this device
- Aug 24, 2005 · Not classified · Z-0107-06: The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems.

## Indications for use
The Meridian™ ST Femoral Stem and Vitalock® Solid Back Acetabular Shell with Peri-Apatite™ Coating are intended to be used in the primary uncemented reconstruction of the proximal femur and acetabulum damaged as a result of non-inflammatory joint disease, avascular necrosis or trauma.

Source page: https://510kreport.com/device/K971206
Methodology: https://510kreport.com/methodology