# K983035: Custom Flanged Acetabular Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Nov 23, 1998 after 84 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
No predicates in its family tree.
219 later devices descend from it; 4 cite it directly.
0 of 220 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) Healey™ Revision Acetabular Component: named in the summary without a submission number
- (no number) Recovery Protusio Cage: named in the summary without a submission number
- (no number) Universal® Acetabular Component: named in the summary without a submission number
- (no number) Mallory-Head® Acetabular Component: named in the summary without a submission number

## Most influential descendants
- K001277: Triflange Acetabular Cup System (2000), 213 descendants of its own
- K031495: Pinnacle Duofix HA Acetabular Cup Prosthesis (2003), 207 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

## Indications for use
The Patient Matched 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 either cemented or 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 Biomet's RingLoc® Acetabular Liners. The device may be used in conjunction with any commercially available femoral component.

Source page: https://510kreport.com/device/K983035
Methodology: https://510kreport.com/methodology