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K Number
K981194
Device Name
FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT
Manufacturer
NEXA ORTHOPEDICS, INC.
Date Cleared
1998-06-30

(89 days)

Product Code
KWH
Regulation Number
888.3720
Type
Traditional
Panel
OR
Reference & Predicate Devices
K780132
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Indications for use of this implant are:

  • Hallux limitus or hallux rigidus. .
  • Painful rheumatoid arthritis. .
  • . Hallux abducto valgus associated with arthritis.
  • Unstable or painful joint from previous surgery. .
Device Description

The Flexible Great Toe implant is a double-stemmed silicone prosthesis to supplement first metatarsophalangeal joint arthroplasty. The implant is designed to act as a dynamic joint spacer between the head of the 1st metatarsal and base of the proximal phalanx. A grommet option is offered for surgeons who choose to utilize grommets in their surgical procedure. This is consistent with the description and intended use of the Swanson Flexible Hinge Toe Implant.

AI/ML Overview

This submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a 510(k) summary for a flexible great toe implant, focusing on substantial equivalence to a predicate device and its intended use. The document discusses:

  • Device Description and Intended Use: A double-stemmed silicone prosthesis for first metatarsophalangeal joint arthroplasty, acting as a dynamic joint spacer.
  • Indications for Use: Hallux limitus/rigidus, painful rheumatoid arthritis, hallux abducto valgus with arthritis, unstable/painful joint from previous surgery.
  • Technological Characteristics: Double-stemmed, silicone, hinged midsection, titanium press fit grommets, angled hinge block, and tapered stems designed based on resected bone geometry.
  • Predicate Device: Swanson Flexible Hinge Toe Implant by Dow Corning (K780132).
  • Performance Standards: None specifically for great toe silicone joint implants at the time, but materials for grommets comply with ASTM F 67.

The document states, "There are currently no performance standards for great toe silicone joint implants." This indicates that formal acceptance criteria based on performance standards are not applicable or were not established in this submission.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because such details are not present in the provided text.

§ 888.3720 Toe joint polymer constrained prosthesis.

(a)
Identification. A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.(b)
Classification. Class II.