# K141001: Alpine Hip Stem; Alpine HA Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development
- Decided: Jul 30, 2014 after 103 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K931641 (1994). 54 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062775: European Style Taper,Press-Fit Hip Stem, Ortho Development Corp. (2007) Summary page 1.
- K963509: Global Taper Tapered Hip System, GT Spectron, Smith & Nephew Richards, Inc. (1997) Summary page 1.
- K042842: Novation 12/14 Press-Fit Femoral Stem, Exactech, Inc. (2004) Summary page 1.

## Most influential descendants
- K173880: Corin TriFit CF Hip Stem (2018), 3 descendants of its own
- K201657: Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads (2021), 2 descendants of its own
- K241472: Icona Hip Stem (2024), 1 descendant of its own
- K261576: Icona Hip Stem (2026), 0 descendants of its own

## Indications for use
This device is intended for use in total hip arthroplasty or hemi-arthroplasty. The device is intended for uncemented, press-fit use only in cases of: 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis 2. Previously failed hip surgery 3. Proximal femoral neck fractures or dislocation 4. Idiopathic avascular necrosis of femoral head 5. Non-union of Proximal femoral neck fractures 6. Treatment of fractures that are unmanageable using other forms of therapy 7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis

Source page: https://510kreport.com/device/K141001
Methodology: https://510kreport.com/methodology