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K Number
K211322
Device Name
Paratrooper Plantar Plate Repair System
Manufacturer
Paragon 28, Inc.
Date Cleared
2021-08-30

(122 days)

Product Code
MBI
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
K133671,K191227
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Paratrooper™ Plantar Plate Repair System is intended for fixation of tissue to tissue to tissue. Specific indications:

Foot/ankle:

  • · Lateral Stabilization
  • · Medial Stabilization
  • · Achilles Tendon Repair
  • Metatarsal Ligament and Tendon Repair
  • · Hallux Valgus Reconstruction
  • · Digital Tendon Transfers
  • · Mid-foot Reconstruction
  • · Plantar Plate Repair
Device Description

The Paratrooper™ Plantar Plate Repair System includes an all-suture soft tissue fixation device. The suture implant comes in one size and is provided attached to a needle or preloaded on an inserter.

AI/ML Overview

The provided text describes a medical device, the Paratrooper™ Plantar Plate Repair System, and its FDA 510(k) clearance. However, it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device. This document is a regulatory submission for a physical medical device, specifically a soft tissue fixation device, and not an AI or imaging diagnostic tool.

Therefore, the requested information elements related to AI/ML device testing (such as "type of ground truth used," "sample size for the training set," "number of experts used to establish the ground truth," "adjudication method," "multi-reader multi-case study," and "standalone performance") are not applicable and cannot be extracted from this document.

The document discusses the substantial equivalence of the Paratrooper™ Plantar Plate Repair System to a predicate device, based on:

  1. Indications for Use: The modified device has the same intended use.
  2. Technological Characteristics: Similar performance, basic design, material, sterilization, and sizes.
  3. Performance Testing: Mechanical performance testing and usability testing were conducted, along with bacterial endotoxin testing.

There is no information in the provided text to populate the requested table or answer the specific questions related to AI/ML device acceptance criteria and study design.

If you are looking for information about an AI/ML medical device, please provide a different document.

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.