# K120578: Accolade II Hip Stem

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics
- Decided: Mar 29, 2012 after 31 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- 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: 5 generations back to K921308 (1994). 19 ancestors in all.
46 later devices descend from it; 9 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103479: Novel Tapered Hip Stem, Stryker Corp. (2011) Summary page 2.
- K013106: 2 Piece Modular Hip Stem, Howmedica Osteonics Corp. (2002) Summary page 1.
- K994366: TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem, Howmedica Osteonics Corp. (2000) Summary page 2.
- K020572: Accolade TMZF HA 132 Degree Size 0 Hip Stem, Howmedica Osteonics Corp. (2002) Summary page 2.
- K023102: Accolade TMZF Plus HA 127 Size 0 Hip Stem, Howmedica Osteonics Corp. (2002) Summary page 2.

## Most influential descendants
- K123604: Abg Iii Monolithic Hip Stem (2013), 30 descendants of its own
- K122853: Novel Fit and Fill Stem (2013), 22 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

## Recalls of this device
- Oct 25, 2013 · Class II · Z-0467-2014: Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5.

## Indications for use
The indications for use of the total hip replacement prostheses include: 1) Noninflammatory 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 and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Additional indicationspecific to use ofAccolade II Fe moral Stems with compatible Howmedica Osgeonics Constrained Liners: 1. 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. Accolade 11 Femoral Stems are intended for cementless use only and are intended for total and hemniarthroplasty procedures.

Source page: https://510kreport.com/device/K120578
Methodology: https://510kreport.com/methodology