# K090845: Apex Arc Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Omni Life Science, Inc.
- Decided: Apr 7, 2010 after 376 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K941847 (1994). 117 ancestors in all.
58 later devices descend from it; 3 cite it directly.
0 of 175 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041950: Apex K2 Hip System, Apex Surgical, LLC (2004) Summary page 1.
- K071916: Metha Hip System, Aesculap Implant Systems, Inc. (2008). Our reading of the summary gave K071946, FDA’s number for Atlantis, Gemini and Gemini+ Abutments in Zirconia for… (Atlantis Components, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Aesculap Metha Hip System”. Summary page 2.
- K083495: Modification to: Metha Hip System, Aesculap Implant Systems, Inc. (2009) Summary page 1.

## Most influential descendants
- 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
- K170339: Summit Hip System (2018), 27 descendants of its own

## Recalls of this device
- Jun 3, 2015 · Class II · Z-2064-2015: Product may breach the inner and outer sterile pouches during shipping or handling.
- May 9, 2014 · Class II · Z-2241-2014: Staining on hip implant.

## Indications for use
The Apex ARC Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: * Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; * Rheumatoid arthritis; * Correction of functional deformity; * Congenital dislocation; * Revision procedures where other treatments or devices have failed; * Femoral neck and trochanteric fractures of the proximal femur.

Source page: https://510kreport.com/device/K090845
Methodology: https://510kreport.com/methodology