The Cart

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K872533 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Straight Cup Currette, 1.7mm

  Class I

  FDA 510(k) K871925 Active Cleared 1 Jun 1987

• Blunt Measuring Probe W/2mm Gradations #tm-1375

  Class I

  FDA 510(k) K873651 Active Cleared 2 Nov 1987

• Serrated Grasping Forceps, Curved Up

  Class I

  FDA 510(k) K873513 Active Cleared 2 Nov 1987

• Standard Knife, Disposable #tm-1610

  Class I

  FDA 510(k) K873712 Active Cleared 15 Oct 1987

• Cup Biopsy Forcep, 1.7mm

  Class I

  FDA 510(k) K871927 Active Cleared 9 Jun 1987

• Serrated Grasping Forceps, Right

  Class I

  FDA 510(k) K873512 Active Cleared 2 Nov 1987

See all devices from Arthropedics, Inc. →

• What is the Arthropedics Cart designed for?

  The Arthropedics Cart is an orthopedic surgical tray designed to support and organize instruments and implants during orthopedic procedures. It falls under product code HRX, which includes devices used to assist in the assembly and handling of orthopedic hardware components. This design helps streamline workflow in sterile operating room environments by keeping tools and implants accessible and orderly.

• Is the Arthropedics Cart reusable or single-use?

  The Arthropedics Cart is explicitly supplied as a reusable device. This means it is intended for repeated use in sterile operating room settings, provided it is properly cleaned, sterilized, and maintained between procedures. Reusability helps reduce waste and costs while ensuring consistent performance.

• What type of sterility is required for use in the operating room?

  Since the Cart is intended for use in sterile operating room environments, it must be sterilized before each procedure to maintain a sterile field. While the data does not specify a particular sterilization method, standard practices such as autoclaving or ethylene oxide sterilization are typically used for reusable surgical trays. Always follow manufacturer guidelines and facility protocols for sterilization.

• Does the Arthropedics Cart have any specific MRI safety considerations?

  The available data for the Arthropedics Cart does not provide explicit details regarding MRI safety. If MRI compatibility is a concern for your facility, it is important to verify whether the materials used in the Cart are non-ferromagnetic and safe for use in MRI environments. Always consult the manufacturer’s documentation or contact Arthropedics, Inc. for clarification.

• How was the FDA clearance for the Arthropedics Cart determined?

  The Arthropedics Cart received FDA clearance under the 510(k) process with clearance number K872533. The decision was classified as Substantially Equivalent (SESE) by the Orthopedic (OR) Advisory Committee, meaning it was determined to have the same intended use, technological characteristics, and performance as a legally marketed device that served as the predicate. This clearance was granted in 1987.