# K955871: Howmedica Asymmetric Stem Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Mar 22, 1996 after 87 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.
241 later devices descend from it; 3 cite it directly.
0 of 242 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) P.C.A.® E-Series Hip System: named in the summary without a submission number
- (no number) Straight Stem Femoral Component: named in the summary without a submission number
- (no number) Anatomic Hip: 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

## Recalls of this device
- Aug 24, 2005 · Not classified · Z-0109-06: The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems.

## Indications for use
All of the named devices are intended for use in the primary and secondary reconstruction of the head and neck portion of the femur. For the specific indication of primary non~inflammatory degenerative joint disease, the Howmedica® Asymmetric Stem Femoral Component is substantially equivalent to the P.C.A.® E-Series Hip and the Howmedica® Straight Stem Femoral Component.

Source page: https://510kreport.com/device/K955871
Methodology: https://510kreport.com/methodology