# K052504: Gluteal Implant, Models RND 5-X, TRD 6-X

- Pathway: 510(k) (Traditional)
- Applicant: Implantech Associates, Inc.
- Decided: Nov 4, 2005 after 52 days
- Product code: MIB (Elastomer, Silicone Block)
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K200610: Customized Contour Implant (2020), 0 descendants of its own

## Indications for use
The Gluteal Implants (Silicone Carving Blocks) are for augmentation and reconstructive surgery. The Implantech Gluteal Implants are carvable to allow the surgeon to shape the device should additional shaping be desired.

Source page: https://510kreport.com/device/K052504
Methodology: https://510kreport.com/methodology