# K984296: Lateralized Intergral Porous Primary Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Feb 18, 1999 after 79 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: 1 generation back to K921225 (1994). 1 ancestor in all.
211 later devices descend from it; 2 cite it directly.
0 of 213 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921225: Integral Total Hip System, Biomet, Inc. (1994) Summary page 2.

## Cited in the summary but kept off the family tree
- K952301: Laser Gas Mixture, Airgas Management, Inc. (1995). Our OCR of the scanned summary read K952301, FDA’s number for Laser Gas Mixture (Airgas Management, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Biomet Lateralized Taperloc Hip System”. Kept off the family tree.

## Most influential descendants
- K030055: Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral Components (2003), 208 descendants of its own
- K043537: Taperloc 12/14 Taper Femoral Components (2005), 160 descendants of its own
- K050124: Porous Coated Acetabular Components (2005), 138 descendants of its own
- K070369: Regenerx Ringloc + Modular Acetabular Shells (2007), 137 descendants of its own
- K093235: Ringloc + Hybrid Acetabular System (2010), 65 descendants of its own

## Indications for use
a.) non-inflammatory degenerative joint disease, including osteoarthritis and avascular Necrosis b.) rheumatoid arthritis c.) correction of functional deformities d.) revisions procedures where other devices or treatments have failed e.) treatment of non-unions, femoral neck trochanteric fractures of the proximal femur with neck involvement, unmanageable using other techniques The Lateralized Integral Hip Stem is intended for press-fit application and is for single use implantation.

Source page: https://510kreport.com/device/K984296
Methodology: https://510kreport.com/methodology