Joint Measurement Indicator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K861264 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Cardiothoracic Ruler

  Class II

  FDA 510(k) K902378 Active Cleared 14 Jun 1990

• Electrocardiograph-ECG Caliper

  Class II

  FDA 510(k) K850021 Active Cleared 8 Feb 1985

• Grip Strength Device (Gsd)

  Class II

  FDA 510(k) K863313 Active Cleared 9 Sep 1986

• Blood Pressure Sleeve W/Tubing

  Class II

  FDA 510(k) K874233 Active Cleared 22 Mar 1988

• Spinal Excursion Meter

  Not classified

  FDA 510(k) K861043 Active Cleared 28 Mar 1986

• What is the Joint Measurement Indicator used for in the operating room?

  The Joint Measurement Indicator is designed to assist surgeons in precisely measuring and aligning hip joint prostheses during surgical implantation. It provides critical dimensional guidance for positioning the acetabular component, helping ensure proper fit and biomechanical function of the hip prosthesis.

• Is the Joint Measurement Indicator intended for reuse or is it single-use?

  The Joint Measurement Indicator is explicitly intended for single-use in orthopedic surgical settings. This ensures sterility and safety for each procedure, as it must be handled according to standard aseptic techniques.

• How is the Joint Measurement Indicator supplied, and what precautions should be taken during handling?

  The device is supplied sterile and must be handled using standard aseptic techniques to maintain sterility. Since it is single-use, it should only be opened and used once per surgical procedure to prevent contamination.

• What regulatory pathway does the Joint Measurement Indicator follow, and how is it classified?

  The Joint Measurement Indicator is classified as a Class III medical device under FDA regulations and is authorized through FDA 510(k) clearance (K861264). It is regulated under the regulation number 888.3320 and was determined to be substantially equivalent to a predicate device.

• Are there multiple sizes or models of the Joint Measurement Indicator, and how are they identified?

  The provided data lists multiple FEI numbers (e.g., 3020282716, 3007923096) and registration numbers, which likely correspond to different sizes or variants of the device. These identifiers are used in regulatory filings and may reflect variations in design or sizing for different patient anatomies or surgical needs.