Neer-III Glenoid Resurfacing Prosthesis

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K873104 ↗

FDA Product Code

KWT

Device Class

Class II

Regulation

21 CFR Part 888.3650

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. →

• What types of shoulder joint issues is the NEER-III Glenoid Resurfacing Prosthesis designed to address in patients?

  The NEER-III Glenoid Resurfacing Prosthesis is specifically designed to resurface the glenoid cavity in patients suffering from degenerative joint conditions, such as arthritis or severe wear, to restore shoulder function and alleviate pain. It is intended for use in orthopedic surgeries where the natural glenoid surface needs to be replaced with a durable, anatomical metal/polymer implant.

• Is the NEER-III Glenoid Resurfacing Prosthesis intended for single-use or can it be reused in multiple procedures?

  The NEER-III Glenoid Resurfacing Prosthesis is explicitly described as a reusable implant, meaning it is intended for use in multiple surgical procedures after proper sterilization and preparation. This makes it cost-effective for high-volume orthopedic settings.

• How is the NEER-III Glenoid Resurfacing Prosthesis secured in place during surgery, and what materials is it made from?

  The prosthesis is secured using cemented fixation, meaning it is attached to the bone with orthopedic cement during surgery. It is manufactured from biocompatible materials, combining metal and polymer components to ensure durability and compatibility with the body.

• What regulatory pathway does the NEER-III Glenoid Resurfacing Prosthesis follow, and what does that mean for its use in clinical settings?

  The device follows the FDA 510(k) clearance pathway (with clearance number K873621), meaning it was determined to be substantially equivalent to a legally marketed predicate device for some indications. This classification places it under Class II – Special Controls for orthopedic devices, ensuring it meets specific safety and performance standards before clinical use.

• How should the NEER-III Glenoid Resurfacing Prosthesis be prepared before use in surgery?

  Since the prosthesis is reusable, it must undergo sterile preparation prior to implantation to ensure safety and prevent infection. This typically involves cleaning, sterilization (e.g., autoclaving or ethylene oxide), and packaging in a sterile barrier before surgical use.