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K Number
K170482
Device Name
Spider Frame External Fixation System
Manufacturer
TASARIMMED TIBBI MAMULLER SANAYI VE TICARET A.S
Date Cleared
2017-09-27

(223 days)

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

Spider Frame Computer Assisted External Fixation system used as a temporary or permanent method of correction and stabilization of the extremity bones.

Indications are:

  1. Post-Traumatic joint contracture which has resulted in loss of range of motion
  2. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
  3. Open and closed fracture fixation
  4. Pseudoarthrosis of long bones
  5. Limb lengthening by epiphyseal or metaphyseal distraction
  6. Correction of bony or soft tissue deformities
  7. Correction of segmental bony or soft tissue defects
  8. Joint arthrodesis
  9. Infected fractures or nonunions,
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a medical device called the "Spider Frame External Fixation System." It details the device's indications for use and regulatory information, but it does not include performance metrics, study details, or acceptance criteria like those typically found in clinical validation reports.

§ 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.