# K173104: Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly

- Pathway: 510(k) (Special)
- Applicant: Total Joint Orthopedics, Inc.
- Decided: Oct 27, 2017 after 28 days
- Product code: OQG (Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, 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: 10 generations back to K810258 (1981). 122 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141972: Klassic HD Acetabular Insert with E-Link Poly, Total Joint Orthopedics, Inc. (2014) Summary page 5.

## Most influential descendants
- K180929: Klassic HD® Hip System (2018), 5 descendants of its own
- 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

## 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 (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/K173104
Methodology: https://510kreport.com/methodology