# K071916: Metha Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, Inc.
- Decided: Jun 2, 2008 after 327 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K955033 (1996). 80 ancestors in all.
68 later devices descend from it; 7 cite it directly.
0 of 148 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.
- K012091: Pro-Femur, Wrightmedicaltechnologyinc (2001) Summary page 1.
- K030733: Mayo Conservative Hip Prosthesis, Model 8026 Series, Zimmer, Inc. (2003) Summary page 1.
- K043123: Apex Modular HA Hip Stem, Apex Surgical, LLC (2005) Summary page 1.

## Most influential descendants
- 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
- K123991: Depuy Corail Amt Hip Prosthesis (2013), 48 descendants of its own

## Recalls of this device
- Jul 19, 2011 · Not classified · Z-3014-2011: Aesculap Implant Systems received a notification from the manufacturer, Aesculap, AG of a fractured CoCr neck adapter.

## 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/K071916
Methodology: https://510kreport.com/methodology