# K123782: Paragon Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Global Manufacturing Technology
- Decided: Mar 14, 2013 after 94 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: 8 generations back to K930712 (1993). 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)
- K042992: Corail Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2005) Summary page 2.
- K052792: Anthology Hip Stem, Smith & Nephew, Inc. (2005) Summary page 2.
- K122512: CS2 Hip System, Consensus Orthopedics, Inc. (2012) Summary page 2.

## Most influential descendants
- K142201: OMNI Interface Acetabular System (2015), 1 descendant of its own
- K171156: OMNI Anseris Hip Stem (2017), 0 descendants of its own

## Indications for use
The Paragon"" Hip System is intended for use as the femoral component of a total hip replacement or partial hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: 1. Degenerative osteoarthritis of the hip. 2. Inflammatory arthritis of the hip. 3. Secondary arthritis of the hip, such as may follow trauma (e.g. fracture of the femoral neck, or fracture and/or dislocation of the hip or acetabulum), or congenital conditions (e.g. developmental dysplasia of the hip). 4. Displaced intracapsular femoral neck fractures where there is a high risk of non-union or avascular necrosis and bone collapse. 5. Avascular Necrosis of the femoral head. 6- Revision of a failed femoral component from previous hip surgery e.g. internal fixation device from previous osteotomy, fracture treatment or hemi-arthroptasty.

Source page: https://510kreport.com/device/K123782
Methodology: https://510kreport.com/methodology