# K112682: Metha Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, LLC
- Decided: Mar 19, 2012 after 186 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: 8 generations back to K955033 (1996). 90 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 92 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080584: Metha Short Stem Hip System, Aesculap Implant System, Inc. (2008) Summary page 1.
- K071916: Metha Hip System, Aesculap Implant Systems, Inc. (2008) Summary page 1.
- K030733: Mayo Conservative Hip Prosthesis, Model 8026 Series, Zimmer, Inc. (2003) Summary page 1.
- K061461: Mayo Conservative Hip Prosthesis, Model 00.65-8026-010-05, Zimmer, Inc. (2006) Summary page 1.
- K091423: Profemur Hip System Modular Necks, Wrightmedicaltechnologyinc (2009) Summary page 1.

## Most influential descendants
- K121684: Novation Lpi Prime Femoral Stem (2012), 1 descendant of its own
- K141821: Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving Femoral Stem, Extended Offset (2014), 0 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/K112682
Methodology: https://510kreport.com/methodology