# K171156: OMNI Anseris Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Omnilife Science
- Decided: Aug 17, 2017 after 119 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: 14 generations back to K941847 (1994). 252 ancestors in all.
No later device cites it as a predicate yet.
0 of 252 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043123: Apex Modular HA Hip Stem, Apex Surgical, LLC (2005) Summary page 4.
- K012918: Apex Modular Alumina Femoral Head, Apex Surgical, LLC (2001) Summary page 4.
- K082468: Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM] (38-43), YY=OD in [MM](44-60), Omni Life Science, Inc. (2009) Summary page 4.
- K100151: Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44 to 60MM), Omnlife Science (2010) Summary page 4.
- K101575: Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810, 303210,303610,304010, Omnlife Science (2010) Summary page 4.
- K101451: Apex Module Hip System Biolox Delta Femoral Head, Omni Life Science, Inc. (2010) Summary page 5.
- K092443: Interface Acetabular Cup Liners, Omni Life Science, Inc. (2009) Summary page 5.
- K152919: OMNI Skirted Heads, Omni Life Science, Inc. (2016) Summary page 5.
- K000788: Apex Modular Hip Stem, Apex Surgical, LLC (2000) Summary page 5.
- K031110: Apex Modular Acetabular Cup, Apex Surgical, LLC (2003) Summary page 5.
- K112779: Apex Modular Acctabular Cup (Now Named Apex Interface Acetabular System), Omnlife Science (2011) Summary page 5.
- K062489: Apex Hcla Acetabular Cup  Liners, Omnilife Science (2007) Summary page 5.
- K073150: Apex-LNK Poly Acetabular Cup Liners, Omni Life Science, Inc. (2008) Summary page 5.
- K082705: Biopro Bipolar Head, Models 18130-18152, Biopro, Inc. (2008) Summary page 5.
- K142201: OMNI Interface Acetabular System, Omnlife Science (2015) Summary page 5.
- K101976: Interface Acetabular System, Acetabular Insert +4 Offset, Omni Life Science, Inc. (2010) Summary page 5.
- K133381: Omni Arc Monoblock Hip Stem, Omnilife Science (2014) Summary page 5.

## Indications for use
The OMNI Anseris Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for hip arthroplasty to treat 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. The OMNI Anseris Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head. For further details, please refer to the Apex Bipolar Head Instructions for Use.

Source page: https://510kreport.com/device/K171156
Methodology: https://510kreport.com/methodology