Implant, Hinge Toe, Flex.

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

510(k) Number

K780132 ↗

FDA Product Code

KWH

Device Class

Class II

Regulation

21 CFR Part 888.3720

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 IMPLANT, HINGE TOE, FLEX. used for?

  It is intended to replace the first metatarsophalangeal (big toe) joint in orthopedic procedures. The device consists of a single flexible across-the-joint component made of silicone elastomer or polyester reinforced silicone elastomer, designed to prevent dislocation in more than one anatomic plane following implantation.

• How is the IMPLANT, HINGE TOE, FLEX. supplied and is it reusable?

  The device is supplied as an implant for surgical use and is intended for implantation only. It is not reusable, meaning it must be discarded after a single surgical procedure to ensure patient safety and device integrity.

• What materials are used in the IMPLANT, HINGE TOE, FLEX.?

  The prosthesis is made of either silicone elastomer or polyester reinforced silicone elastomer. These materials provide the necessary flexibility and durability to function as a constrained joint replacement while resisting dislocation in multiple planes.

• What regulatory pathway was used for the IMPLANT, HINGE TOE, FLEX.?

  The device received FDA 510(k) clearance under submission number K780132, indicating it was found substantially equivalent to a legally marketed predicate device. It is classified as a Class II medical device under FDA regulation 888.3720.