# K180929: Klassic HD® Hip System

- Pathway: 510(k) (Special)
- Applicant: Total Joint Orthopedics, Inc.
- Decided: May 9, 2018 after 30 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K810258 (1981). 125 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 131 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 5.
- K141972: Klassic HD Acetabular Insert with E-Link Poly, Total Joint Orthopedics, Inc. (2014) Summary page 5.
- K161073: Klassic HD Hip System, Total Joint Othopedics, Inc. (2016) Summary page 5.
- K143407: Klassic HD Hip System, Total Joint Othopedics, Inc. (2014) Summary page 5.
- K173104: Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly, Total Joint Orthopedics, Inc. (2017) Summary page 5.

## Most influential descendants
- K213580: Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length (2021), 1 descendant of its own
- K243809: Biolox® Delta Revision heads (2025), 0 descendants of its own
- K221675: United U2 femoral head, 22mm delta ceramic head (2022), 0 descendants of its own
- K220483: Platform® Acetabular System (2022), 0 descendants of its own
- K191399: BIOLOX CONTOURA Ceramic Femoral Head (2019), 0 descendants of its own

## Indications for use
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 (1JD): 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/K180929
Methodology: https://510kreport.com/methodology