# K060072: Monoblock Press-Fit Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Omni Life Science, Inc.
- Decided: Aug 24, 2006 after 227 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K932481 (1994). 9 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001942: SL-Plus and SLR-Plus Stems, Plus Orthopedics (2000) Summary page 2.
- K021178: SL-Plus Lateralized Stem, Plus Orthopedics (2002) Summary page 2.
- K041950: Apex K2 Hip System, Apex Surgical, LLC (2004) Summary page 2.

## Most influential descendants
- K110947: Apex K1 Hip Stem (2011), 6 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
- K133381: Omni Arc Monoblock Hip Stem (2014), 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

## Recalls of this device
- Sep 11, 2019 · Class II · Z-0169-2020: Stems missing porous coating on the device.

## Indications for use
The Apex Ki Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: * Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; • Rheumatoid arthritis; * Correction of functional deformity; • Congenital dislocation; - Revision procedures where other treatments or devices have failed; - Femoral neck and trochanteric fractures of the proximal femur.

Source page: https://510kreport.com/device/K060072
Methodology: https://510kreport.com/methodology