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Synthes Cannulated Angle Blade Plate (CABP) System

by Synthes (Usa)

510(k) K974537

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK974537 Date18 Feb 1998ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KTT
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Synthes Cannulated Angle Blade Plate (CABP) System is an orthopedic fixation device classified as an Appliance, Fixation, Nail/blade/plate Combination, Multiple Component under product code KTT. It consists of a straight plate with an integrated cannulated blade designed for fracture fixation, allowing guide wire placement and adjustment through the cannulation. The device features undersurface cuts that reduce bone contact area to preserve cortical blood supply and minimize damage-induced porosity, while also improving bending uniformity.

It is supplied as a multiple-component system for use in orthopedic procedures, specifically indicated for proximal humerus and distal tibia fixation. The device received FDA 510(k) clearance (K974537) on February 18, 1998, and is regulated as a Class II medical device subject to special controls. It is manufactured by Synthes (USA) and was submitted from their facility in Paoli, Pennsylvania.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Synthes Cannulated Angle Blade Plate (CABP) System used for?

    The Synthes Cannulated Angle Blade Plate (CABP) System is indicated for fracture fixation in orthopedic procedures, specifically for proximal humerus and distal tibia fractures, as stated in the device description. It functions as a multiple-component fixation system combining a straight plate with an integrated cannulated blade to stabilize bone fragments.

  • How is the Synthes Cannulated Angle Blade Plate (CABP) System supplied and what are its key design features?

    The device is supplied as a multiple-component system and includes a straight plate with an integrated cannulated blade that allows guide wire placement and adjustment through the cannulation. It features undersurface cuts that reduce bone contact area to preserve cortical blood supply, minimize damage-induced porosity, and improve bending uniformity during fixation.

  • Is the Synthes Cannulated Angle Blade Plate (CABP) System sterile and intended for single use or reuse?

    The provided device data does not specify whether the Synthes Cannulated Angle Blade Plate (CABP) System is supplied sterile or intended for single use or reuse. This information is not included in the NAME, MANUFACTURER, DESCRIPTION, or SPECIFICATIONS fields, so no conclusion can be drawn about its sterility or reusability from the given facts.