# K101976: Interface Acetabular System, Acetabular Insert +4 Offset

- Pathway: 510(k) (Special)
- Applicant: Omni Life Science, Inc.
- Decided: Sep 14, 2010 after 63 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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 K930712 (1993). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031110: Apex Modular Acetabular Cup, Apex Surgical, LLC (2003) Summary page 1.
- K062489: Apex Hcla Acetabular Cup  Liners, Omnilife Science (2007) Summary page 2.
- K073150: Apex-LNK Poly Acetabular Cup Liners, Omni Life Science, Inc. (2008) Summary page 1.
- K100555: Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNK, Omni Life Science, Inc. (2010) Summary page 1.

## Most influential descendants
- K171156: OMNI Anseris Hip Stem (2017), 0 descendants of its own

## Recalls of this device
- May 18, 2018 · Class II · Z-2540-2018: The Internal packaging, the pouch and patient labels are improperly labeled.

## Indications for use
The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cup are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses 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 prbximal femur.

Source page: https://510kreport.com/device/K101976
Methodology: https://510kreport.com/methodology