# K012364: Aml Hip Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Oct 19, 2001 after 85 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: 2 generations back to K931641 (1994). 3 ancestors in all.
158 later devices descend from it; 4 cite it directly.
0 of 162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931641: Porocoat Porous Coating, Depuy, Inc. (1994) Summary page 1.
- K953694: Depuy Vision Aml Hip Prothesis, Depuy, Inc. (1996) Summary page 1.
- K003800: Aml Hip Prosthesis, DePuy Orthopaedics, Inc. (2001) Summary page 1.

## Most influential descendants
- K030236: Acumatch P-Series Porous Press-Fit Femoral Component (2003), 146 descendants of its own
- K041906: Exactech 12/14 Total Hip System (2004), 145 descendants of its own
- K042842: Novation 12/14 Press-Fit Femoral Stem (2004), 64 descendants of its own
- K051556: Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene (2005), 60 descendants of its own
- K070479: Exactech Novation Crown Cup and Liners (2007), 59 descendants of its own

## Indications for use
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. Avascular necrosis of the femoral head. Acute traumatic fracture of the femoral head or neck. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. Certain cases of ankylosis. The AML® Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prostheses to the bone cement.

Source page: https://510kreport.com/device/K012364
Methodology: https://510kreport.com/methodology