# K062775: European Style Taper,Press-Fit Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Jan 16, 2007 after 120 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to P960047 (1997). 35 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043537: Taperloc 12/14 Taper Femoral Components, Biomet, Inc. (2005) Summary page 1.
- K991485: Synergy Porous Size 8 Hip Stem, Smith & Nephew, Inc. (1999) Summary page 1.
- K921181: Mallory-Head Total Hip System, Biomet, Inc. (1994) Summary page 1.
- K020580: X-Series BI-Metric Hip Femoral Components, Biomet, Inc. (2002) Summary page 1.
- K921301: Taperloc Femoral Stem and Universal Acetabular Com, Biomet, Inc. (1994) Summary page 1.
- K972228: Meridian Titanium Femoral Stems, Howmedica, Inc. (1997) Summary page 1.
- K020572: Accolade TMZF HA 132 Degree Size 0 Hip Stem, Howmedica Osteonics Corp. (2002) Summary page 1.
- K964218: Perfecta Plasma Spray Hip Stem, Wrightmedicaltechnologyinc (1997) Summary page 1.

## Most influential descendants
- K131022: Ovation 10/12 Hip Stem (2013), 5 descendants of its own
- K141001: Alpine Hip Stem; Alpine HA Hip Stem (2014), 4 descendants of its own
- K173880: Corin TriFit CF Hip Stem (2018), 3 descendants of its own
- K133386: Ovation Tribute Hip Stem; Ovation Narrow Hip Stem (2014), 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

## Recalls of this device
- Jan 11, 2011 · Not classified · Z-1671-2011: Component of total hip arthroplasty may break during surgical procedure.
- Jan 11, 2011 · Not classified · Z-1672-2011: Component of total hip arthroplasty may break during surgical procedure.
- Jan 11, 2011 · Not classified · Z-1673-2011: Component of total hip arthroplasty may break during surgical procedure.
- Jan 11, 2011 · Not classified · Z-1670-2011: Component of total hip arthroplasty may break during surgical procedure.

## Indications for use
The OvationTM Hip Stem is used in non-cemented total hip replacement in cases of: 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis. 2. Previously failed surgery. 3. Proximal femoral neck fractures or dislocation. 4. Idiopathic avascular necrosis of the 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/K062775
Methodology: https://510kreport.com/methodology