Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3540](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3540) → FTR — Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

# FTR · Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

_General, Plastic Surgery · 21 CFR 878.3540 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTR

## Overview

- **Product Code:** FTR
- **Device Name:** Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
- **Regulation:** [21 CFR 878.3540](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3540)
- **Device Class:** 3
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **Implant:** yes

## Identification

(1) Single-lumen silicone gel-filled breast prosthesis. A single-lumen silicone gel-filled breast prosthesis is a silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane. The shell either contains a fixed amount cross-linked polymerized silicone gel, filler, and stabilizers or is filled to the desired size with injectable silicone gel at time of implantation. The device is intended to be implanted to augment or reconstruct the female breast.(2) Double-lumen silicone gel-filled breast prosthesis. A double lumen silicone gel-filled breast prosthesis is a silicone rubber inner shell and a silicone rubber outer shell, both shells made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane. The inner shell contains fixed amounts of cross-linked polymerized silicone gel, fillers, and stabilizers. The outer shell is inflated to the desired size with sterile isotonic saline before or after implantation. The device is intended to be implanted to augment or reconstruct the female breast.(3) Polyurethane covered silicone gel-filled breast prosthesis. A polyurethane covered silicone gel-filled breast prosthesis is an inner silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane, with an outer silicone adhesive layer and an outer covering of polyurethane; contained within the inner shell is a fixed amount of cross-linked polymerized silicone gel, fillers, and stabilizers and an inert support structure compartmentalizing the silicone gel. The device is intended to be implanted to augment or reconstruct the female breast.

## Classification Rationale

Class III.

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P230005](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTR/P230005.md) | Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas | Motiva USA, LLC | Sep 26, 2024 | APPR |
| [P060028](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTR/P060028.md) | MENTOR MEMORYSHAPE BREAST IMPLANTS | Mentor Worldwide, LLC | Jun 14, 2013 | APPR |
| [P040046](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTR/P040046.md) | NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS | Allergan | Feb 20, 2013 | APPR |
| [P070004](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTR/P070004.md) | SIENTRA SILICONE GEL BREAST IMPLANTS | Tiger Aesthetics Medical, LLC | Mar 9, 2012 | APPR |
| [P030053](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTR/P030053.md) | MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS | Mentor Corp. | Nov 17, 2006 | APPR |
| [P020056](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTR/P020056.md) | NATRELLE SILICONE-FILLED BREAST IMPLANTS | Allergan | Nov 17, 2006 | APPR |

## Top Applicants

- Allergan — 2 clearances
- Mentor Corp. — 1 clearance
- Mentor Worldwide, LLC — 1 clearance
- Motiva USA, LLC — 1 clearance
- Tiger Aesthetics Medical, LLC — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTR](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTR)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com