# K200706: Sientra OPUS Silicone Gel Breast Implant Sizer

- Pathway: 510(k) (Traditional)
- Applicant: Sientra, Inc.
- Decided: Nov 16, 2020 after 243 days
- Product code: MRD (Mammary Sizer)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K010709 (2001). 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)
- K183163: Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix, Motiva USA, LLC (2019) Summary page 4.

## Indications for use
The Sientra OPUS® Silicone Gel Breast Implant Sizer is a single-use, sterile, intraoperative device indicated for temporary placement during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size of the long-term Sientra OPUS® Breast Implant to be implanted.

Source page: https://510kreport.com/device/K200706
Methodology: https://510kreport.com/methodology