MLI Soft Tissue Screw & Washer System

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

510(k) Number

K962194 ↗

FDA Product Code

MBI

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Mli Interference Screw

  Class II

  FDA 510(k) K953350 Active Cleared 30 Jan 1996

• Expanded Body Suture

  Class II

  FDA 510(k) K961025 Active Cleared 15 Apr 1996

• Mli Modular Staple

  Class II

  FDA 510(k) K962705 Active Cleared 1 Oct 1996

• Cross Pin

  Class II

  FDA 510(k) K961920 Active Cleared 17 Sep 1996

• Medicinelodge, Inc. Set Screw

  Class II

  FDA 510(k) K961905 Active Cleared 6 Aug 1996

• Zipknot, Model 1017-3000

  Class II

  FDA 510(k) K072525 Active Cleared 5 Oct 2007

See all devices from Medicinelodge, Inc. →

• What is the MLI Soft Tissue Screw & Washer System used for?

  The MLI Soft Tissue Screw & Washer System is a fixation device designed for anchoring soft tissue grafts to bone during cruciate ligament, tendon, or other soft tissue graft repair procedures. It is specifically indicated for use in soft tissue graft fixations to the femur or tibia.

• How is the MLI Soft Tissue Screw & Washer System supplied?

  The system is supplied as a Class II medical device with Special Controls. It is manufactured by Medicinelodge, Inc. and received FDA 510(k) clearance with K number K962194 on July 30, 1996. The device is designed for single-use in soft tissue graft fixation procedures.

• What are the regulatory requirements for the MLI Soft Tissue Screw & Washer System?

  The MLI Soft Tissue Screw & Washer System is classified as a Fastener, Fixation, Nondegradable, Soft Tissue medical device. It has received FDA 510(k) clearance with K number K962194, indicating it is substantially equivalent to predicate devices for its intended use in soft tissue graft fixations to bone.

• What sizes and models of the MLI Soft Tissue Screw & Washer System are available?

  The device data does not specify available sizes or models of the MLI Soft Tissue Screw & Washer System. For detailed information regarding available sizes, models, and specifications, please contact the manufacturer, Medicinelodge, Inc., directly.