# K083495: Modification to: Metha Hip System

- Pathway: 510(k) (Special)
- Applicant: Aesculap Implant Systems, Inc.
- Decided: Jan 15, 2009 after 51 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- 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: 9 generations back to K941847 (1994). 112 ancestors in all.
59 later devices descend from it; 1 cites it directly.
0 of 171 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071916: Metha Hip System, Aesculap Implant Systems, Inc. (2008) Summary page 1.
- K080584: Metha Short Stem Hip System, Aesculap Implant System, Inc. (2008) Summary page 1.
- K082991: Biolox Delta Ceramic Femoral Head, Aesculap Implant Systems, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K123991: Depuy Corail Amt Hip Prosthesis (2013), 48 descendants of its own
- K150862: DePuy Actis Duofox Hip Prosthesis (2015), 38 descendants of its own

## Indications for use
The Metha® 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/K083495
Methodology: https://510kreport.com/methodology