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LSF (R) Total Hip System - Bipolar Component

by Implant Technology, Inc.

510(k) K883212

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK883212 Date22 Nov 1988ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KXA
Device Class
Class II
Regulation
21 CFR Part 888.3400
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a femoral resurfacing prosthesis, specifically a bipolar component of the LSF (R) Total Hip System. It is designed for use in hip arthroplasty to replace the femoral head and neck while preserving the native femoral canal. The bipolar design allows for dual articulation, providing a range of motion intended to reduce the risk of dislocation.

The device is supplied as a single-use, sterile implant and must be stored in a dry, cool environment prior to use. It is intended for surgical implantation in patients requiring hip resurfacing or reconstruction. The device is regulated under FDA Class 2 and was authorized through the 510(k) premarket notification process with a substantial equivalence determination.

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Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the LSF (R) Total Hip System Bipolar Component used for?

    It is a femoral resurfacing prosthesis designed for hip arthroplasty. It replaces the femoral head and neck while preserving the native femoral canal, and its bipolar design allows for dual articulation to provide a range of motion intended to reduce the risk of dislocation.

  • How is the LSF (R) Bipolar Component supplied?

    It is supplied as a single-use, sterile implant. This means it is intended for one surgical procedure and must not be re-sterilized or reused.

  • How should the LSF (R) Bipolar Component be stored before use?

    It must be stored in a dry, cool environment prior to use. Proper storage conditions are critical to maintain the sterility and integrity of the implant until the time of surgery.

  • What is the regulatory classification of the LSF (R) Bipolar Component?

    The device is regulated under FDA Class 2 and was authorized through the 510(k) premarket notification process with a substantial equivalence determination.