# K151055: Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE

- Pathway: 510(k) (Special)
- Applicant: Mentor Worldwide, LLC
- Decided: May 20, 2015 after 30 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: 3 generations back to K010709 (2001). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131853: Mentor Memoryshape Resterilizable Gel Sizer, Mentor Worldwide, LLC (2013) Summary page 4.

## Most influential descendants
- K183163: Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix (2019), 1 descendant of its own
- K243271: MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (2025), 0 descendants of its own
- K200706: Sientra OPUS Silicone Gel Breast Implant Sizer (2020), 0 descendants of its own

## Indications for use
The MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryShape breast implant to be implanted.

Source page: https://510kreport.com/device/K151055
Methodology: https://510kreport.com/methodology