# K243271: MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Worldwide, LLC
- Decided: Jan 13, 2025 after 89 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: 4 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)
- K131853: Mentor Memoryshape Resterilizable Gel Sizer, Mentor Worldwide, LLC (2013) Summary page 5.
- K151055: Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE, Mentor Worldwide, LLC (2015) Summary page 5.
- K241552: MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer, Mentor Worldwide, LLC (2024) Summary page 5.

## 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. The MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryGel™ breast implant to be implanted. The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer is indicated for single use only for temporary insertion intraoperatively to evaluate the shape and size of the MemoryGel™ Enhance Breast Implant to be implanted.

Source page: https://510kreport.com/device/K243271
Methodology: https://510kreport.com/methodology