MACI
autologous cultured chondrocytes
Vericel Corporation
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1226230 | 3002836339 | Vericel Corporation | 1 | N | 2026-01-01 | 64 Sidney St CAMBRIDGE MA US 02139 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 191131 | 2030360801 | K171520 | SteriZign Signatur Device Protection System | KCT | 2018-02-07 |
| 191131 | 1281449976 | BK050036 | |||
| 191131 | 1908032665 | BH990200 | |||
| 191131 | 1663899700 | ||||
| 191131 | 1021009451 | ||||
| 191131 | 1143187557 | ||||
| 191131 | 1228292496 | ||||
| 191131 | 1328361543 | ||||
| 191131 | 1483453324 | ||||
| 191131 | 1583759381 | ||||
| 191131 | 1818322529 | ||||
| 191131 | 1819864084 | ||||
| 191131 | 1975416674 | ||||
| 191131 | 1976362654 | ||||
| 191131 | 2036809140 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KCT | 1 | 2018-02-07 |
NDC#
GUDID#
MACI Surgical Implantation Kit - The MACI Surgical Implantation Kit is intended to assist with MACI® (autologous cultured chondrocytes on porcine collagen membrane) knee surgery. The kit contains instruments to assist surgeons with preparing the defect, cutting the implant, and transferring the implant.The MACI Surgical Implantation Kit contains:1 - Sterilization Tray;1 - Silicone Cutting Block, Single Use Only;1 - Tungsten Carbide Scissors, manufactured by Symmetry Surgical, Inc.;2 - Toothless Adsons, manufactured by Symmetry Surgical, Inc.;1 - 4.5mm Ring Curette, manufactured by Richard Wolf Medical Instruments Corp.; 1 - 6.0mm Ring Curette, manufactured by Richard Wolf Medical Instruments Corp.; 1 - Mallet, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Oval 13X20mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Oval 15X23mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Oval 20X25mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Oval 22X32mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Round D15mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Round D28mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Oblong 10X30mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC
2022-11-09
Cutting Block - The Cutting Block is intended to provide a sterile cutting surface during surgery. The Cutting Block may be used for cutting MACI(R) (autologous cultured chondrocytes on porcine collagen membrane) implant during implantation surgery. The Cutting Block may be supplied individually in a sealed pouch, or it may be supplied unwrapped as part of the MACI Surgical Implantation Kit.
2022-11-09
MACI Arthroscopic Instruments - 18mm V-Shuttle delivery device
2024-09-18
MACI Arthroscopic Instruments - 18mm V-Shuttle and Two-Pack MACI Applicator Kit
2024-09-18
MACI Arthroscopic Instruments - 17 mm x 28 mm Max Arthroscopic Cutter and 17 mm x 28 mm MACI Cutter Kit
2024-09-18
MACI Arthroscopic Instruments - MACI Applicator
2024-08-26
MACI Arthroscopic Instruments - 15mm V-Shuttle delivery device
2024-08-26
MACI Arthroscopic Instruments - 6.5mm Open-ring curette
2024-08-26
MACI Arthroscopic Instruments - 3.6mm Rake curette
2024-08-26
MACI Arthroscopic Instruments - 4mm x 5mm Square curette
2024-08-26
MACI Arthroscopic Instruments - 14 mm x 26 mm Min arthroscopic cutter
2024-08-26
MACI Arthroscopic Instruments - 15mm x 3cm Cannula Assembly
2024-08-26
MACI Arthroscopic Instruments - 15mm V-Shuttle and Two-Pack MACI Applicator Kit
2024-08-26
MACI Arthroscopic Instruments - 12 mm x 21 mm Min Arthroscopic Cutter and 12 mm x 21 mm MACI Cutter Kit
2024-08-26
MACI Arthroscopic Instruments - 14 mm x 26 mm Min Arthroscopic Cutter and 14 mm x 26 mm MACI Cutter Kit
2024-08-26
MACI Arthroscopic Instruments - 14 mm x 26 mm Max Arthroscopic Cutter and 14 mm x 26 mm MACI Cutter Kit
2024-08-26
MACI Arthroscopic Instruments - MACI Arthroscopic Cutting Block
2024-08-26
MACI Arthroscopic Instruments - 15mm x 4cm Cannula Assembly
2024-08-26
MACI Arthroscopic Instruments - 18mm x 4cm Cannula assembly
2024-08-26
MACI Arthroscopic Instruments - 12 mm x 21 mm Min arthroscopic cutter
2024-08-26
MACI Arthroscopic Instruments - 14 mm x 26 mm Max Arthroscopic Cutter
2024-08-26
MACI Arthroscopic Instruments - 17 mm x 28 mm Max Arthroscopic Cutter
2024-08-26
MACI Arthroscopic Instruments - 12 mm x 21 mm MACI Cutter
2024-08-26
MACI Arthroscopic Instruments - 14 mm x 26 mm MACI Cutter
2024-08-26
MACI Arthroscopic Instruments - 17 mm x 28 mm MACI Cutter
2024-08-26
MACI Arthroscopic Instruments - MACI Applicators, Two-Pack
2024-08-26
Cartilage Biopsy Transport Kit - The Cartilage Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live cartilage biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of MACI - (Container, specimen mailer and storage, temperature controlled, sterile)
2022-12-08
Epicel (cultured epidermal autografts) - Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures a minimum of 50 cm2 in area.Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
2024-02-05
Skin Biopsy Transport Kit - The Skin Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live skin biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of EPICEL - (Container, specimen mailer and storage, temperature controlled, sterile)
2020-09-24
Cartilage Biopsy Transport Kit - The Cartilage Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live cartilage biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of MACI - (Container, specimen mailer and storage, temperature controlled, sterile)
2020-09-24
MACI Implantation; Surgical Implantation; Vericel Surgical Implantation - 4
2022-07-15
Cartilage Biopsy Transport Medium - DMEM with HEPES, Gentamicin, and Glutamax
2022-12-13
Skin Biopsy Transport Medium - DMEM with Amikacin and Vancomycin
2022-12-13
Skin Biopsy Transport Kit - The Skin Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live skin biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of EPICEL - (Container, specimen mailer and storage, temperature controlled, sterile)
2022-12-08
BD Vacutainer EDTA (K2) Blood Collection Tubes - 366643
2022-12-08
VonSeal® 95kPA Biohazard Specimen Bag - N/A
2022-12-08
Blood Collection Kit - The Blood Collection Kit is intended to provide a way to collect and transport venous blood samples to a biobanking facility. The Blood Collection Kit contains blood specimen collection devices and associated materials necessary to transport the samples to a biobanking facility. This includes two BD 10.0mL K2 EDTA (K2E) Plus Blood Collection Tubes (366643) and one VonSeal® 95kPA Biohazard Specimen Bag.
2022-09-23
Epicel (cultured epidermal autografts) - Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures approximately 50 cm2 in area.Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
2017-11-17