Compression System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K831076 ↗

FDA Product Code

JDO

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• 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

• Wire & Steinman Pins

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  FDA 510(k) K831005 Active Cleared 18 May 1983

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

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  FDA 510(k) K940537 Active Cleared 29 Aug 1995

• Segmental Spinal Instrumentation System

  Not classified

  FDA 510(k) K864337 Active Cleared 16 Dec 1986

See all devices from Kirschner Medical Corp. →

• What is the Compression System used for?

  The Compression System is intended as a metallic bone fixation appliance and accessory for implantation in orthopedic surgical settings, specifically for proximal femoral fixation, consisting of one or more metallic components and their fasteners.

• Is the Compression System sterile or non-sterile when supplied?

  The Compression System is supplied as a non-sterile implant system, meaning it must be sterilized by the user prior to implantation in accordance with established medical device reprocessing protocols.

• Can the Compression System be reused after implantation?

  The Compression System is designed as a reusable implant system, allowing for multiple uses after appropriate cleaning, disinfection, and sterilization between surgical procedures, as indicated in its labeling and manufacturer instructions.

• What regulatory pathway was used for the Compression System?

  The Compression System was cleared via the FDA 510(k) pathway under submission K831076, receiving a traditional clearance decision on April 28, 1983, based on a determination of substantial equivalence to a predicate device.

• Who manufactures the Compression System and where is it located?

  The Compression System is manufactured by Kirschner Medical Corp., located at 803 N. Front St. Suite 3, McHenry, IL 60050, United States, as indicated in the device registration and authorization records.