# K103479: Novel Tapered Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Mar 10, 2011 after 104 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- 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: 4 generations back to K921308 (1994). 18 ancestors in all.
53 later devices descend from it; 10 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K120578: Accolade II Hip Stem (2012), 46 descendants of its own
- 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

## 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 indication specific to use of Accolade 11 Femoral Stems with compatible Howmedica Osteonics 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 distocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability. Accolade Il Femoral Stems are intended ft;r cementless use only and are intended for total and hemiarthroplasty procedures.

Source page: https://510kreport.com/device/K103479
Methodology: https://510kreport.com/methodology