Kirschner Spinal Fixator KMS-1

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

510(k) Number

K884690 ↗

FDA Product Code

KWP

Device Class

Class II

Regulation

21 CFR Part 888.3050

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 is the Kirschner Spinal Fixator KMS-1 used for?

  The KMS-1 is designed to provide internal support and stabilization to the spine, helping to align and immobilize vertebral segments during surgical procedures or as part of post-operative recovery. It falls under the product code KWP (Fixation, Spinal Interlaminal), indicating its role in orthopedic spinal stabilization.

• Is the KMS-1 supplied sterile, and how should it be prepared for use?

  The KMS-1 is not sterile upon receipt and must be sterilized prior to use. It is intended for reuse in controlled clinical settings like operating rooms or orthopedic clinics, so adherence to standard medical sterilization protocols is required before clinical application.

• What regulatory pathway does the KMS-1 follow, and what does that mean for its use?

  The KMS-1 received FDA 510(k) clearance (K884690) under Traditional review, demonstrating substantial equivalence for certain orthopedic spinal fixation indications. This means it has been evaluated and approved for its intended use based on comparisons to legally marketed predicate devices, ensuring compliance with U.S. regulatory standards.

• Can the KMS-1 be used in MRI environments?

  The available data does not specify an MRI safety classification for the KMS-1. Clinicians should verify compatibility with their MRI equipment and protocols before use, as metallic components in spinal fixators may pose risks in magnetic fields.

• What types of clinical settings is the KMS-1 intended for?

  The KMS-1 is designed for use in controlled clinical environments such as operating rooms or orthopedic clinics. Its reusable nature and requirement for sterilization before use align it with procedures where infection control and repeated use are managed under strict protocols.