# K141972: Klassic HD Acetabular Insert with E-Link Poly

- Pathway: 510(k) (Traditional)
- Applicant: Total Joint Orthopedics, Inc.
- Decided: Oct 9, 2014 after 80 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: 9 generations back to K810258 (1981). 121 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 136 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.
- K112802: Pipeline Total Hip System, Pipeline Orthopedics (2012) Summary page 5.
- K094035: Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM, Stelkast Company (2011) Summary page 5.

## Most influential descendants
- K173104: Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly (2017), 6 descendants of its own
- K161073: Klassic HD Hip System (2016), 6 descendants of its own
- K180263: EcoFit Vit E Acetabular System (2018), 5 descendants of its own
- K180929: Klassic HD® Hip System (2018), 5 descendants of its own
- K203420: EcoFit® Hip System (2021), 4 descendants of its own

## Indications for use
The Klassic HD™ Acetabular Insert with E-Link™ Poly, 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/K141972
Methodology: https://510kreport.com/methodology