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K Number
K192447
Device Name
Superelastic Staple
Manufacturer
Neosteo
Date Cleared
2020-02-28

(175 days)

Product Code
JDR
Regulation Number
888.3030
Type
Traditional
Panel
Orthopedic
Reference & Predicate Devices
K070031,K142111,K061798
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Superelastic Staple are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

Device Description

The Superelastic Staple consists of staples available in several lengths. All the implants are made of NiTi alloy.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Superelastic Staple." This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It explicitly states that no clinical studies were performed.

Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no clinical performance data for the device's efficacy or accuracy is presented in the provided document.

The document details the following regarding the device and its assessment:

  • Device Name: Superelastic Staple
  • Regulation Number: 21 CFR 888.3030 (Single/multiple component metallic bone fixation appliances and accessories)
  • Regulatory Class: Class II
  • Product Code: JDR
  • Indications for Use: The Superelastic Staple is indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
  • Predicate Devices:
    • Biopro Memory Staples® (K061798) from Biopro (Primary)
    • Memometal Memory Staples (Memoclip – Easy Clip – For Fusion) (K070031) from Memometal
    • ARCAD Compressive Osteosynthesis Staple, EXPRESS Compressive Osteosynthesis Staple (K142111) from Novastep
  • Device Description: Made of NiTi alloy per ASTM F2063.
  • Non-Clinical Tests Performed:
    • Static bending test (ASTM F564 – Annex 4)
    • Dynamic bending test (ASTM F564 Annex 1)
    • Axial pull-out strength (ASTM F564 Annex 2)
    • Transition temperature (ASTM F2004)
    • Corrosion susceptibility testing (ASTM F2129)
    • Cytotoxicity testing (ISO 10993-5:2009)
    • Acute Systemic Toxicity testing (ISO 10993-11:2006)
    • Chemical Characterization (ISO 10993-18:2005)
  • Clinical Test Summary: "No clinical studies were performed."

Given this, I cannot fill out the requested table or answer the specific questions about clinical study design, acceptance criteria, sample sizes, expert involvement, or ground truth, as that information is not part of this 510(k) submission. This document relies solely on non-clinical (mechanical and biocompatibility) testing to demonstrate substantial equivalence.

§ 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.