# K110807: Abg II Monolithic Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: May 25, 2011 after 63 days
- Product code: MAY (Prosthesis,  Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish)
- 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: 1 generation back to K092406 (2009). 1 ancestor in all.
31 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092406: Abg II Modular Hip Stem, Howmedica Osteonics Corp. (2009) Summary page 1.

## Most influential descendants
- K123604: Abg Iii Monolithic Hip Stem (2013), 30 descendants of its own
- K143085: Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach (2015), 21 descendants of its own
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K171768: Trident® II Acetabular System (2017), 10 descendants of its own
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (2018), 8 descendants of its own

## Indications for use
The indications for use for total hip arthroplasty include: noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and, nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Additional indication specific to use of ABGTM II Monolithic Hip Stem with compatible Howmedica Osteonics Constrained Liners: When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability. Stryker's ABGTM II Monolithic Hip Stem is intended for cementless use only and is intended for total and hemi-arthroplasty procedures.

Source page: https://510kreport.com/device/K110807
Methodology: https://510kreport.com/methodology