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K Number
K061798
Device Name
BIOPRO MEMORY STAPLE
Manufacturer
BIOPRO, INC.
Date Cleared
2006-08-21

(56 days)

Product Code
JDR
Regulation Number
888.3030
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. Hand and foot bone fragment and osteotomy fixation and joint arthrodesis of the hand and foot bones.
  2. Fixation of soft tissue to bone such as anterior cruciate reconstruction
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a device called "Biopro Memory Staple," indicating that the device has been found substantially equivalent to a predicate device.

The letter discusses:

  • The trade/device name and regulation information.
  • The substantial equivalence determination by the FDA.
  • General controls and potential additional controls applicable to the device.
  • Requirements for marketing the device.
  • Contact information for further inquiries.
  • Indications for Use for the Biopro Memory Staple.

There is no mention of:

  • Specific acceptance criteria (e.g., performance metrics, thresholds).
  • A study design, methodology, or results demonstrating performance against any criteria.
  • Details regarding sample sizes, data provenance, expert qualifications, ground truth establishment, or comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the text provided.

§ 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.