# K123604: Abg Iii Monolithic Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 16, 2013 after 268 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K921308 (1994). 22 ancestors in all.
30 later devices descend from it; 3 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110807: Abg II Monolithic Hip Stem, Stryker Corp. (2011)
- K103479: Novel Tapered Hip Stem, Stryker Corp. (2011) Summary page 1.
- K120578: Accolade II Hip Stem, Howmedica Osteonics (2012) Summary page 1.

## Most influential descendants
- 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
- K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System (2019), 7 descendants of its own

## Recalls of this device
- Jan 21, 2016 · Class II · Z-0875-2016: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

## Indications for use
The indications for use for total hip arthroplasty include: 1. noninfiammatory degenerative joint disease, including osteoarthritis and avascular necrosis; 2. rheumatoid arthritis; 3. correction of functional deformity; 4. revision procedures where other treatments or devices have failed; and, 5. nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with bead involvement that are unmanageable using other techniques. Additional indication specific to use of AnatoTm 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, bane loss, soft tissue laxity, neuromuscular disease, or intra-operative instability. The AnatoTm Hip Stem is intended for cementless use only and is intended for total and hemi-arthroplasty procedures.

Source page: https://510kreport.com/device/K123604
Methodology: https://510kreport.com/methodology