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Infinity Collarless/Microtaper Trochanteric Mod

by Dow Corning Wright 510(k)

Active United States

510(k) K920968

Overview

The Infinity Collarless/Microtaper Trochanteric Mod is a semi-constrained hip prosthesis (product code LZO) designed for orthopedic applications. It is constructed from metal, ceramic, or polymer materials and is intended for use in hip arthroplasty, providing stability and articulation within the hip joint. The device is specifically engineered for trochanteric fixation, accommodating both cemented and uncemented implantation techniques.

This device is supplied sterile and intended for single-use in surgical settings. It has received FDA 510(k) clearance (K920968) and is classified under Class II with special controls. The Infinity Collarless/Microtaper Trochanteric Mod adheres to orthopedic standards for biocompatibility and durability. Proper sterile storage and handling are required to maintain its integrity prior to use.

Infinity Collarless/Microtaper Trochanteric Mod

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK920968 Date5 May 1993ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Infinity(R) Collarless/Microtaper Trochanteric Mod
510(k) Number
FDA Product Code
LZO
Device Class
Class II
Regulation
21 CFR Part 888.3353
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Infinity Collarless/Microtaper Trochanteric Mod used for?

    The Infinity Collarless/Microtaper Trochanteric Mod is a semi-constrained hip prosthesis designed specifically for hip arthroplasty. It provides stability and articulation within the hip joint, with a focus on trochanteric fixation. This design accommodates both cemented and uncemented implantation techniques, making it versatile for various surgical needs in orthopedic procedures.

  • How is the Infinity Collarless/Microtaper Trochanteric Mod supplied and prepared for use?

    The device is supplied sterile and intended for single-use in surgical settings. It must be handled and stored under sterile conditions to preserve its integrity before use. Proper storage ensures the device remains uncontaminated and ready for implantation.

  • What materials are used in the Infinity Collarless/Microtaper Trochanteric Mod?

    The prosthesis is constructed from metal, ceramic, or polymer materials, depending on the specific model or variant. These materials are chosen to meet orthopedic standards for biocompatibility and durability, ensuring long-term performance within the body.

  • Is this device reusable or intended for single-use?

    The Infinity Collarless/Microtaper Trochanteric Mod is explicitly intended for single-use only. This design choice aligns with sterile surgical practices to minimize infection risks and ensure patient safety.

  • What regulatory clearance does this device hold?

    The Infinity Collarless/Microtaper Trochanteric Mod has received FDA 510(k) clearance under the reference number K920968. It is classified as a Class II medical device with special controls, adhering to orthopedic standards for safety and efficacy.