# K200610: Customized Contour Implant

- Pathway: 510(k) (Traditional)
- Applicant: Implantech Associates, Inc.
- Decided: Dec 23, 2020 after 289 days
- Product code: FWP (Prosthesis, Chin, Internal)
- Device class: 2
- Regulation: 21 CFR 878.3550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K913761 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191130: Customized Contour Implant, Implantech Associates, Inc. (2019) Summary page 5.
- K052504: Gluteal Implant, Models RND 5-X, TRD 6-X, Implantech Associates, Inc. (2005) Summary page 5.
- K052505: Calf Implant, Model EC17-X, Implantech Associates, Inc. (2005) Summary page 5.
- K952708: Pectoralis Implant, Spirit Ridge Technologies (1995) Summary page 5.

## Indications for use
The Customized Contour Implant is intended for augmentation, reconstructive and cosmetic surgery. The Customized Contour Implant is pre-shaped to the surgeon’s specification to meet the needs of a particular patient, for example facial implants, gluteal implants, calf implants, or pectoralis implants.

Source page: https://510kreport.com/device/K200610
Methodology: https://510kreport.com/methodology