# K970501: Pegged Acetabular Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Apr 30, 1997 after 79 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.
509 later devices descend from it; 3 cite it directly.
0 of 510 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) 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
- (no number) Reflection™ Porous-Coated Acetabular Component: named in the summary without a submission number
- (no number) PCA® Acetabular Component: named in the summary without a submission number
- (no number) Duraloc™ 300 Acetabular Cup System: named in the summary without a submission number

## Most influential descendants
- K032396: Ringloc 36MM Line and Modular Femoral Heads (2003), 505 descendants of its own
- K023357: Arcpm 1050 Resin-Hips (2002), 480 descendants of its own
- K042051: Arcomxl Polyethylene Liners (2005), 355 descendants of its own
- K051411: Arcomxl Polyethylene Liners and Biolox Delta Heads (2005), 344 descendants of its own
- K061312: 36MM Biolox Delta Ceramic Heads (2006), 343 descendants of its own

## Indications for use
The Pegged Acetabular Component is intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnoses. The device is a single use implant.

Source page: https://510kreport.com/device/K970501
Methodology: https://510kreport.com/methodology