Silastic H.P. Trapexial Implant

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K781756 ↗

FDA Product Code

KYI

Device Class

Class II

Regulation

21 CFR Part 888.3770

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Silastic Scleral Sponge II W/Circling Bd

  Class II

  FDA 510(k) K800140 Active Cleared 3 Mar 1980

• Silastic U-Tube Kit

  Class I

  FDA 510(k) K781526 Active Cleared 20 Sep 1978

• Silastic Brand Q7-2091 Gastric Sump Tube

  Class II

  FDA 510(k) K760708 Active Cleared 23 Nov 1976

• Silastic Percutaneous Gastrointest. Tube

  Class II

  FDA 510(k) K760945 Active Cleared 23 Nov 1976

• Silastic Bone Plug H.P.(Cement Restrict)

  Class II

  FDA 510(k) K800898 Active Cleared 2 May 1980

• Implant, H.P. Condylar

  Class II

  FDA 510(k) K781870 Active Cleared 9 Feb 1979

See all devices from Dow Corning Corp. Healthcare Industries Materials →

• What is the SILASTIC H.P. TRAPEXIAL IMPLANT used for?

  This device is a prosthesis specifically designed for the carpal trapezium bone in the wrist, intended to replace or support the trapezium in orthopedic procedures involving wrist joint reconstruction or stabilization.

• Is the SILASTIC H.P. TRAPEXIAL IMPLANT supplied sterile or for single use?

  The implant is supplied as a single-use device; however, the data does not indicate it is provided sterile, and sterility is not explicitly stated in the labeling information available, so users must consult the product labeling for sterilization status before use.

• What material is the SILASTIC H.P. TRAPEXIAL IMPLANT made from, and what is its regulatory classification?

  The implant is made from Silastic H.P., a biomedical grade silicone elastomer intended for human implantation, and is classified as a Class II medical device under FDA regulation, having received 510(k) clearance under K781756 as substantially equivalent to a predicate device.