K Number
K963420
Device Name
CANCELLOUS SCREW WASHER
Date Cleared
1996-11-15

(77 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cancellous Screw Washers designed for use in conjunction with cancellous bone screws. These implants are intended for fracture fixation of the metatarsals, and tarsal bones.
Device Description
The proposed device, the Cancellous Screw Washer claims substantial equivalence to a currently marketed device, Synthes Screw Washer. The Synthes Screw Washer and the proposed device are available in either Titanium or Stainless Steel. Both function as added support under bone screw head and have no significant design differences.
More Information

Synthes Screw Washer

Not Found

No
The summary describes a mechanical implant (screw washer) and makes no mention of AI or ML technology.

No
The device is described as an implant used for fracture fixation, which is a structural support device rather than one that directly provides therapy or treatment to a condition.

No
The device, Cancellous Screw Washers, is intended for fracture fixation of metatarsals and tarsal bones, functioning as added support under bone screw heads. This is a therapeutic and supportive function, not a diagnostic one.

No

The device description clearly states it is a physical implant (Cancellous Screw Washer) made of Titanium or Stainless Steel, designed for fracture fixation. It is not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "fracture fixation of the metatarsals, and tarsal bones." This describes a surgical implant used directly on the patient's body for structural support.
  • Device Description: The description details a physical implant ("Cancellous Screw Washers") made of Titanium or Stainless Steel, designed to be used with bone screws.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on in vitro analysis.

Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

The Cancellous Screw Washers designed for use in conjunction with cancellous bone screws. These implants are intended for fracture fixation of the metatarsals, and tarsal bones.

Product codes

Not Found

Device Description

The proposed device, the Cancellous Screw Washer claims substantial equivalence to a currently marketed device, Synthes Screw Washer. The Synthes Screw Washer and the proposed device are available in either Titanium or Stainless Steel. Both function as added support under bone screw head and have no significant design differences.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

metatarsals, and tarsal bones

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

Synthes Screw Washer

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.

0

K9634 Cancellous Screw Washer 510(k)Summary - Safety and Effectiveness

Nov 1 5 1996

The proposed device, the Cancellous Screw Washer claims substantial equivalence to a currently marketed device, Synthes Screw Washer. The Synthes Screw Washer and the proposed device are available in either Titanium or Stainless Steel. Both function as added support under bone screw head and have no significant design differences. The Cancellous Screw Washers designed for use in conjunction with cancellous bone screws. These implants are intended for fracture fixation of the metatarsals, and tarsal bones.

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