# K030861: HA Pmi Flanged Acetabular Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jun 12, 2003 after 86 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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 K983035 (1998). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983035: Custom Flanged Acetabular Component, Biomet, Inc. (1998) Summary page 1.

## Most influential descendants
- K092098: Patient Specific Acetabular Reconstruction Prosthesis (2010), 1 descendant of its own
- K123598: Smith & Nephew, Inc. Hip System Instrumentation (2013), 0 descendants of its own

## Indications for use
The HA PMI Flanged Acetabular Component is indicated for use in patients requiring reconstruction of the hip joint due to disease, deformity or trauma. The device is intended for cementless application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints. The device is a single use implant. The device is to be used in conjunction with any commercially available femoral component.

Source page: https://510kreport.com/device/K030861
Methodology: https://510kreport.com/methodology