KM-3 Acetabular Component

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K855042 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SN

• Dosimetric Release of Gamma Radiation

  Class II

  FDA 510(k) K832211 Active Cleared 29 Sep 1983

• Austin Moore Hip Prosthesis

  Not classified

  FDA 510(k) K863896 Active Cleared 19 Nov 1986

• Dimension Total Hip Prosthesis

  Class II

  FDA 510(k) K853333 Active Cleared 3 Sep 1985

• Compression System

  Class II

  FDA 510(k) K831076 Active Cleared 28 Apr 1983

• Wire & Steinman Pins

  Class II

  FDA 510(k) K831005 Active Cleared 18 May 1983

• Kirschner(R) Modular II-C(Tm) Total Shoulder System

  Class II

  FDA 510(k) K940537 Active Cleared 29 Aug 1995

See all devices from Kirschner Medical Corp. →

• Is the KM-3 Acetabular Component designed for single-use or can it be reused in multiple procedures?

  The KM-3 Acetabular Component is explicitly described as a reusable medical device. Since it is intended for use in orthopedic surgical settings, it must undergo proper sterile preparation before each implantation to ensure patient safety and device integrity. Reuse requires strict adherence to sterile surgical protocols to prevent contamination.

• What type of fixation method does the KM-3 Acetabular Component use, and why is this important for stability?

  The KM-3 Acetabular Component is cemented into place using bone cement, which provides secure fixation within the pelvic bone. This method is critical for stability in total hip arthroplasty, as it ensures a strong bond between the implant and the surrounding bone, reducing the risk of loosening or displacement over time.

• How should the KM-3 Acetabular Component be stored to maintain its integrity before use?

  Since the KM-3 is a reusable device requiring sterile preparation prior to implantation, it must be stored in a clean, dry environment following manufacturer guidelines to prevent damage or contamination. Before use, it must undergo proper sterilization procedures as outlined in sterile surgical protocols to ensure it remains safe for implantation.

• What regulatory pathway was followed for FDA clearance of the KM-3 Acetabular Component, and what does this mean for its use?

  The KM-3 Acetabular Component was cleared through the FDA 510(k) process (K855042) under a Traditional review, classified as a Class III device. This means it was determined to be substantially equivalent to a legally marketed predicate device for some indications, ensuring it meets FDA safety and effectiveness standards before being authorized for use in the U.S. market.

• What is the primary clinical purpose of the KM-3 Acetabular Component’s semi-constrained design?

  The semi-constrained interface of the KM-3 Acetabular Component is designed to improve stability and range of motion in total hip arthroplasty by balancing femoral component movement with acetabular fixation. This reduces dislocation risks while allowing natural joint motion, making it suitable for patients requiring enhanced biomechanical support.