# K031474: SC Total Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Orthopedic Alliance, LLC
- Decided: Oct 15, 2003 after 159 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
200 later devices descend from it; 2 cite it directly.
0 of 201 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SL-Plus Hip Stem (Plus Orthopedics): named in the summary without a submission number
- (no number) Zweymuller SL Hip System (AlloPro): named in the summary without a submission number
- (no number) Lester Press Fit Hip System (Kirschner): named in the summary without a submission number
- (no number) Alloclassic Zweymuller SL Hip Stem (Sulzer Medica): named in the summary without a submission number

## Most influential descendants
- K042344: Excia Total Hip System (2005), 198 descendants of its own
- K060918: Excia Total Hip System 12/14 Trunnion with Ceramic Head (2006), 90 descendants of its own
- K060437: Excia Total Hip System with U-Cap (2006), 90 descendants of its own
- K080584: Metha Short Stem Hip System (2008), 83 descendants of its own
- K070981: Search Evolution (LC) Total Knee System (Plasmapore) (2007), 79 descendants of its own

## Indications for use
The SC Total Hip System is indicated for use in the treatment of severely disabled hip joints resulting from painful osteo-, rheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries. The SC Femoral Hip Stem is indicated for use with or without bone cement. The SC Acetabular Cup is for use with bone cement only.

Source page: https://510kreport.com/device/K031474
Methodology: https://510kreport.com/methodology