Femoral Proximal Diagnosal Screw, Femoral Transver

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

510(k) Number

K852026 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Cradle, Hospital Bed Clothing

  Class I

  FDA 510(k) K892877 Active Cleared 15 Jun 1989

• Interlocking Femoral Nail(Left & Right) Tibial Nai

  Class II

  FDA 510(k) K852020 Active Cleared 22 May 1985

• Schultz Phalangeal Component Driver

  Class I

  FDA 510(k) K870847 Active Cleared 13 Mar 1987

• Warsaw Orthopedic I Bone Plate

  Class II

  FDA 510(k) K870727 Active Cleared 9 Mar 1987

• Schultz Metacarpophalangeal Joint Prosthesis

  Not classified

  FDA 510(k) K860074 Active Cleared 11 Feb 1986

• Fixation Staple Driver/Extractor

  Class II

  FDA 510(k) K832884 Active Cleared 20 Oct 1983

See all devices from Warsaw Orthopedic, Inc. →

• What is the Femoral Proximal Diagnosal Screw, Femoral Transver used for?

  This device is designed specifically for internal fixation of femoral fractures. By providing transversal screw placement, it stabilizes proximal femoral structures to support fracture healing during orthopedic surgery. Its purpose is to ensure secure fixation where bone alignment and stability are critical.

• How is the Femoral Transver Screw supplied and prepared for use?

  The screw is supplied as a single-use, sterile orthopedic implant. It is intended exclusively for controlled surgical environments, meaning it must be opened and used only once per patient. Sterility is maintained until the packaging is compromised, so proper aseptic techniques are required during handling.

• Is the Femoral Transver Screw reusable or intended for single-use?

  This device is explicitly intended for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and integrity. Single-use ensures patient safety and compliance with surgical best practices.

• What regulatory approval does the Femoral Transver Screw hold?

  The device holds FDA 510(k) clearance under the reference number K852026, granted in 1985. It is classified under the Orthopedic advisory committee and falls under the product code HWC for screws, fixation, bone. This clearance confirms it meets FDA standards for safety and effectiveness as a Class II medical device.

• How should the Femoral Transver Screw be stored before use?

  The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Typically, this involves keeping it in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid contamination or physical damage to the packaging before surgery.