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K Number
K151992
Device Name
FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control
Manufacturer
ZIMMER, INC.
Date Cleared
2015-11-02

(105 days)

Product Code
KTT,JDW
Regulation Number
888.3030
Type
Traditional
Panel
Orthopedic
Reference & Predicate Devices
K113383
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The FastFrame™ External Fixation System - Knee Spanning is indicated for use in treatment of long bone (distal femur, proximal tibia) fractures. Specifically, the system is intended for:

  • Stabilization of open or closed fractures about the knee, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated;

  • Arthrodesis and osteotomies with associated soft tissue problems about the knee;

  • Stabilization of limbs after removal of total knee arthroplasty for infection or other failure;

  • Stabilization of non-unions about the knee; and

  • Intraoperative temporary stabilization to assist with indirect reduction.

The FastFrame™ External Fixation System - Damage Control is indicated for use in treatment of mid-shaft long bone (femur, tibia) fractures. Specifically, the system is intended for:

  • Stabilization of open or closed fractures of the femur and tibia, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated;

  • Stabilization of non-unions; and

  • Intraoperative temporary stabilization to assist with indirect reduction.

Device Description

The purpose of this 510(k) is to obtain marketing clearance for the new devices, the FastFrame External Fixation System - Knee Spanning, and FastFrame External Fixation System - Damage Control. The systems consists of fixation half- pins attached to rigid clamps connected by adjustable telescoping tubes (bars) and are intended for use in the treatment of long bone fractures that require external fixation.

AI/ML Overview

The provided FDA 510(k) summary for the FastFrame™ External Fixation System does not contain information about the acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML medical device. Instead, it details the regulatory submission for an external fixation system, which is a physical orthopedic device.

The document discusses:

  • Device Description: An external fixation system (bars, clamps, fixation pins) used for stabilizing long bone fractures.
  • Intended Use/Indications for Use: Specific applications for knee spanning and damage control in fracture treatment, arthrodesis, osteotomies, and temporary stabilization.
  • Comparison to Predicate Device: Highlights differences such as pre-assembled frames and sterile kits for the FastFrame system versus intra-operative assembly and non-sterile provision for the predicate.
  • Performance Data (Nonclinical): States that mechanical testing confirmed substantial equivalence in full construct rigidity and interconnection performance to the predicate device. It also mentions MRI Conditional status.
  • Clinical Performance: Explicitly states that clinical data and conclusions were not needed to show substantial equivalence for these devices.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details for an AI/ML device is not available in this document. This document pertains to a traditional medical device (hardware) and its mechanical performance, not a software algorithm.

§ 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.