# K984408: 130 Modified Integral Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Feb 12, 1999 after 65 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 K920955 (1994). 3 ancestors in all.
209 later devices descend from it; 1 cites 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 1.
- K940715: Osteonics Omnifit AD Hip Stem Series, Osteonics Corp. (1995) Summary page 1.
- K920955: Apr (R) Hip Syst & Natural-Hip (R) for Uncement Use, Intermedics Orthopedics (1994) Summary page 1.

## 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) non-union, femoral neck, and trochanteric fractures of the proximal femur with head involvement. d) correction of functional deformities e) revisions of previously failed surgeries and treatments The 130° Modified Integral Femoral Component is intended for press-fit or cemented application. The device is a single use implant.

Source page: https://510kreport.com/device/K984408
Methodology: https://510kreport.com/methodology