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K Number
K062040
Device Name
SBI TRIHEDRON MTP HEMI GT
Manufacturer
SMALL BONE INNOVATIONS INC.
Date Cleared
2006-10-03

(76 days)

Product Code
KWD
Regulation Number
888.3730
Type
Traditional
Panel
Orthopedic
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SBi Trihedron MTP Hemi Great Toe is intended as a resurfacing implant for the metatarso-phalangeal joint for:

  1. Arthritic degeneration of the metatarso-phalangeal joint that has resulted in disabling pain, limited motion and loss of normal ambulatory function of the forefoot.
  2. Degenerative arthritis
  3. Rheumatoid arthritis
  4. Bunion deformity associated with arthritis of the metatarso-phalangeal joint
  5. correction of functional deformity;
  6. revision procedures where other treatments and devices have failed; and
  7. treatment of fractures that are unmanageable using other techniques.
Device Description

The SBi Trihedron MTP Hemi Great Toe Implant consists of a single piece cobalt chromium head and stem. The stem of the implant is coated with CPTi coating and is designed to be inserted into the shaft of the proximal phalanx of the great toe in the metatarsophalangeal joint. The head of the implant articulates with distal head of the first metatarsal. The implant is available in several sizes, each of which can be used in right or left feet. A range of trial sizers for each size of implant is available to aid in bone preparation.

AI/ML Overview

There is no information regarding acceptance criteria or a study proving the device meets acceptance criteria in the provided text. The document is a 510(k) summary for the SBi Trihedron MTP Hemi Great Toe, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on performance against specific acceptance criteria through a clinical study.

Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC study details, standalone performance, or details about the training set.

The document states: "Documentation is provided which demonstrated the SBi Trihedron MTP Hemi Great Toe to be substantially equivalent to other legally marketed devices." This indicates that the regulatory approval was based on a comparison to existing devices, not on a new study assessing specific performance metrics against pre-defined acceptance criteria.

§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.

(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.