# K050441: Taper 2 Porous Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jun 29, 2005 after 127 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- 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 K921301 (1994). 2 ancestors in all.
85 later devices descend from it; 1 cites it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921301: Taperloc Femoral Stem and Universal Acetabular Com, Biomet, Inc. (1994) Summary page 2.
- K943230: Mayo Hip Prosthesis, Mayo Clinic (1997) Summary page 2.

## Most influential descendants
- K062994: Lateralized Taperloc Microplasty Femoral Components (2007), 84 descendants of its own
- K072417: Smith & Nephew Mis Hip Stem (2008), 44 descendants of its own
- K110400: Taperloc Complete Microplasty Stem (2011), 34 descendants of its own
- K080625: Smith & Nephew Mis Hip Stem with Stiktite (2008), 19 descendants of its own
- K103256: Smith & Nephew SMF Hip Stem (2011), 16 descendants of its own

## Indications for use
The Taper 2 Porous Femoral Stem is indicated for use in patients requiring total hip replacement due to the following: * Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis * Rheumatoid arthritis * Correction of functional deformity * Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques * Revision of previously failed femoral head resurfacing component Taper 2 Porous Femoral Stems are intended for uncemented use only. Specific indications for compatible components that can be used with the above femoral stems include: Constrained Liners (LK030047) Constrained liners are intended for general use in skeletally mature individuals undergoing primary and/or revision surgery at high risk of hip dislocation due to history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. OSS / Salvage Systems / Total Femur (K974558, K002757, K021380, K033871) Salvage/Oncology Hip and Total Femur components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrodesis. Interlocking Stems (K990830, K042774) Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.

Source page: https://510kreport.com/device/K050441
Methodology: https://510kreport.com/methodology