# K994366: TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Mar 16, 2000 after 80 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K941141 (1994). 7 ancestors in all.
76 later devices descend from it; 6 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972228: Meridian Titanium Femoral Stems, Howmedica, Inc. (1997) Summary page 1.
- K955871: Howmedica Asymmetric Stem Femoral Component, Howmedica Corp. (1996) Summary page 1.
- K941366: Osteonics Omnifit AD-HA Hip Stem Series, Osteonics Corp. (1995) Summary page 1.
- K921301: Taperloc Femoral Stem and Universal Acetabular Com, Biomet, Inc. (1994) Summary page 1.

## Most influential descendants
- K103479: Novel Tapered Hip Stem (2011), 53 descendants of its own
- 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

## Recalls of this device
- Oct 23, 2012 · Class II · Z-0656-2013: Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.
- Jul 14, 2011 · Not classified · Z-0075-2012: Stryker Orthopaedics has become aware that a size 3 Accolade stem was in a box labeled as a size 5 Accolade stem.
- Mar 1, 2011 · Not classified · Z-2557-2011: Accolade TMZF Plus Hip Stems are being recalled due to grit blast media which was observed in the drive hole.

## Indications for use
The TMZF® Press Fit HA Stem and TMZF® Press Fit Plus HA Stem are indicated for cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. Additionally, these femoral stems can be used in the treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. These stems are also indicated for use in revision procedures where other treatments or devices have failed.

Source page: https://510kreport.com/device/K994366
Methodology: https://510kreport.com/methodology