# K080584: Metha Short Stem Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant System, Inc.
- Decided: May 9, 2008 after 67 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K955033 (1996). 75 ancestors in all.
83 later devices descend from it; 9 cite it directly.
0 of 158 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042344: Excia Total Hip System, Aesculap, Inc. (2005) Summary page 1.
- K060437: Excia Total Hip System with U-Cap, Aesculap, Inc. (2006) Summary page 1.
- K060918: Excia Total Hip System 12/14 Trunnion with Ceramic Head, Aesculap, Inc. (2006) Summary page 1.
- K030733: Mayo Conservative Hip Prosthesis, Model 8026 Series, Zimmer, Inc. (2003) Summary page 1.

## Most influential descendants
- K082991: Biolox Delta Ceramic Femoral Head (2008), 63 descendants of its own
- K083495: Modification to: Metha Hip System (2009), 59 descendants of its own
- K090845: Apex Arc Hip Stem (2010), 58 descendants of its own
- K111193: Apex Arc Hip Stem (2011), 53 descendants of its own
- K113242: Apex Arc Hip Stem (2012), 52 descendants of its own

## Indications for use
The Metha® Short Stem Hip System (uncemented, press-fit fixation) is intended to replace a hip joint. The device is intended for: · skeletally mature individuals undergoing primary surgery for total hip replacement · patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur. · patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis · patients suffering from disability due to previous fusion · patients with acute femoral neck fractures

Source page: https://510kreport.com/device/K080584
Methodology: https://510kreport.com/methodology