# K082146: Metha Short Stem Hip System XL Femoral Head

- Pathway: 510(k) (Special)
- Applicant: Aesculap Implant Systems, Inc.
- Decided: Sep 9, 2008 after 41 days
- Product code: LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K955033 (1996). 76 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080584: Metha Short Stem Hip System, Aesculap Implant System, Inc. (2008)
- K040191: Bicontact Hip Stem and Femoral Head, Aesculap (2004) Summary page 1.

## Most influential descendants
- K090299: Biolox Option Ceramic Femoral Head and Metha XL Heads (2009), 1 descendant of its own
- K172235: CoreHip® System (2018), 0 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/K082146
Methodology: https://510kreport.com/methodology