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Lima-Lio Smr Shoulder System - Humeral Stems, Lima-Lio Smr Shoulder System - Humeral Bodies,

by Lima-Lto S.P.A.

510(k) K100858

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK100858 Date10 Dec 2010ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2539-2015 FDA Class II initiated 14 Aug 2015
    • Terminated Z-2540-2015 FDA Class II initiated 14 Aug 2015 on shared 510(k) K100858

    The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
KWT
Device Class
Class II
Regulation
21 CFR Part 888.3650
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 LIMA-LIO SMR SHOULDER SYSTEM is a device intended for use in orthopedic applications, specifically comprising humeral stems and humeral bodies as part of a shoulder system. It is designed for implantation in the humerus to support shoulder joint reconstruction or replacement procedures.

The device is supplied as a non-sterile, reusable implant system and is indicated for use in surgical settings. It has received FDA 510(k) clearance under K100858 with product code KWT, and was determined to be substantially equivalent to a predicate device. No information regarding sterility, single-use status, MRI safety, sizes, or storage conditions is provided in the data.

Other devices from Lima-Lto S.P.A.

Questions

AI-generated answers, 23 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 LIMA-LIO SMR Shoulder System used for?

    The LIMA-LIO SMR Shoulder System is intended for use in orthopedic applications, specifically comprising humeral stems and humeral bodies as part of a shoulder system. It is designed for implantation in the humerus to support shoulder joint reconstruction or replacement procedures.

  • How is the LIMA-LIO SMR Shoulder System supplied and is it sterile or single-use?

    The device is supplied as a non-sterile, reusable implant system. It is not provided sterile and is designed for multiple uses after appropriate cleaning and sterilization by the healthcare facility.

  • What regulatory clearance does the LIMA-LIO SMR Shoulder System have?

    The LIMA-LIO SMR Shoulder System has received FDA 510(k) clearance under submission number K100858 with product code KWT. It was determined to be substantially equivalent to a predicate device through a traditional 510(k) review process.