# K131454: Klassic HD (TM) Extended Offset Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Total Joint Orthopedics, Inc.
- Decided: Feb 12, 2014 after 268 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: 9 generations back to K810258 (1981). 96 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100445: Klassic HD Hip System, Total Joint Orthopedics, Inc. (2010) Summary page 2.
- K103479: Novel Tapered Hip Stem, Stryker Corp. (2011) Summary page 2.
- K033664: Modification to Alloclassic Zweymuller SL Offset Femoral Stem, Centerpulse Orthopedics, Inc. (2003) Summary page 2.
- K914675: Modular Femoral Head with Offset Trunion, Kirschner Medical Corp. (1992) Summary page 2.

## Most influential descendants
- K151440: Klassic HD Hip System (2015), 1 descendant of its own
- K171962: Klassic HD® Hip System (2017), 0 descendants of its own

## Indications for use
The Klassic HD Extended Offset Femoral Head for use within the Klassic HD Hip System is intended for prosthetic replacement without bone cement in treatment of the following: • Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia. • Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis. • Those patients with failed previous surgery where pain, deformity or dysfunction persists. • Revision of a previously failed hip arthroplasty. • Patients who require a total hip replacement.

Source page: https://510kreport.com/device/K131454
Methodology: https://510kreport.com/methodology