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LSF HA Coated Femoral Hip

by Implant Technology, Inc.

510(k) K915617

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 NumberK915617 Date28 May 1992ClearedStatusActive

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  • Withdrawn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
MEH
Device Class
Class II
Regulation
21 CFR Part 888.3353
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.

The LSF HA Coated Femoral Hip is a hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis intended to be implanted to replace a hip joint. It limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. The device consists of a femoral stem made of alloys to be fixed in the femur.

The LSF HA Coated Femoral Hip is supplied as a single-use device and is regulated under FDA 510(k) clearance K915617 with product code MEH. It is manufactured by Implant Technology, Inc. and received FDA clearance on May 28, 1992. The device is intended for orthopedic use and is available in various sizes as specified by the manufacturer.

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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 HA Coated Femoral Hip used for?

    The LSF HA Coated Femoral Hip is a hip joint metal/ceramic/polymer semi-constrained prosthesis intended to replace a hip joint. It limits translation and rotation through its articulating surfaces geometry without linkage across-the-joint.

  • How is the LSF HA Coated Femoral Hip supplied?

    The LSF HA Coated Femoral Hip is supplied as a single-use device. It is manufactured by Implant Technology, Inc. and available in various sizes as specified by the manufacturer.

  • What is the regulatory status of the LSF HA Coated Femoral Hip?

    The LSF HA Coated Femoral Hip is regulated under FDA 510(k) clearance K915617 with product code MEH. It received FDA clearance on May 28, 1992, and is intended for orthopedic use.

  • What materials is the LSF HA Coated Femoral Hip made of?

    The device consists of a femoral stem made of alloys to be fixed in the femur. It is a metal/ceramic/polymer semi-constrained prosthesis that can be cemented or nonporous uncemented.