# K100445: Klassic HD Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Total Joint Orthopedics, Inc.
- Decided: Dec 3, 2010 after 289 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: 8 generations back to K810258 (1981). 74 ancestors in all.
25 later devices descend from it; 12 cite it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073068: Accin Hip System, Accelerated Innovation, LLC (2008) Summary page 2.
- K030373: Alloclassic Zweymueller SL/SLL Femoral Stem, Centerpulse Orthopedics, Inc. (2003) Summary page 2.
- K991226: Foundation Porous Hip Stem, Encore Orthopedics, Inc. (1999) Summary page 2.
- K051737: Modification to V-40/C-Taper Adapter Sleeve, Howmedica Osteonics Corp. (2005) Summary page 2.
- K082844: Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve, Encore Medical L.P. (2008) Summary page 2.
- K072888: Revelation and Linear Hip Stems and FMP Acetabular Shells (Spiked, Hemispherical and Flared), Encore Medical L.P. (2008) Summary page 2.
- K092386: R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners, Smith & Nephew, Inc. (2009)
- K031110: Apex Modular Acetabular Cup, Apex Surgical, LLC (2003)
- K062489: Apex Hcla Acetabular Cup  Liners, Omnilife Science (2007) Summary page 2.
- K073150: Apex-LNK Poly Acetabular Cup Liners, Omni Life Science, Inc. (2008) Summary page 2.

## Most influential descendants
- K143407: Klassic HD Hip System (2014), 16 descendants of its own
- K141972: Klassic HD Acetabular Insert with E-Link Poly (2014), 14 descendants of its own
- K163577: Ecofit® Hip System (2017), 9 descendants of its own
- 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

## Indications for use
The Kiassic HDTm 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 painflul 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/K100445
Methodology: https://510kreport.com/methodology