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SP-CL Hip Stem and LCU Hip System

by WALDEMAR LINK GmbH & Co. KG

510(k) K213770

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213770↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK213770 Date13 Sep 2022ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

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

Overview

AI-generated summary, 20 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 SP-CL Hip Stem and LCU Hip System is a modular orthopedic prosthesis designed for total hip arthroplasty. It includes a cementless hip stem (SP-CL) and a cemented/uncemented hip stem (LCU) with optional coatings, such as HX or PoroLink (microporous). The system features a straight stem with a tapered lateral shoulder and a rectangular cross-section, combining anatomical design principles with cementless or cemented fixation options. Both versions adhere to a harmonized concept for improved stability and integration with the femur.

This system is supplied as a modular orthopedic implant for surgical use in total hip replacement procedures. The SP-CL version is intended for cementless fixation, while the LCU version offers both cemented and uncemented options with surface coatings for enhanced osseointegration. The device is regulated under FDA 510(k) clearance (K213770) and MDR compliance, with specifications categorized under 21 CFR 888.3353. It is not intended for MRI use and must be handled as a sterile, single-use implant in controlled surgical environments.

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Questions

AI-generated answers, 20 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 types of fixation options are available with the SP-CL Hip Stem and LCU Hip System, and how do they differ?

    The SP-CL Hip Stem is designed for cementless fixation, relying on direct bone integration for stability. In contrast, the LCU Hip Stem offers both cemented and uncemented options, allowing surgeons to choose based on patient-specific needs. The LCU version also includes optional coatings like HX or PoroLink to further enhance osseointegration when used without cement.

  • Are the stems in this system compatible with MRI procedures, and why or why not?

    No, the SP-CL Hip Stem and LCU Hip System is explicitly not intended for MRI use. This is likely due to the metallic components and design, which could interfere with MRI imaging or generate heat, posing risks to the patient. Always verify imaging protocols with your radiology team before proceeding.

  • How is the SP-CL Hip Stem and LCU Hip System supplied, and what should I consider regarding sterility and reuse?

    The system is supplied as a sterile, single-use orthopedic implant for surgical use only. It must be handled in a controlled environment to maintain sterility. Reuse is not recommended, as single-use implants are designed for one surgical procedure to ensure patient safety and compliance with regulatory standards.

  • What surface coatings are available for the LCU Hip Stem, and what purpose do they serve?

    The LCU Hip Stem offers optional coatings, including HX and PoroLink (microporous). These coatings are designed to improve osseointegration—meaning they promote stronger, more stable bonding between the implant and bone—particularly when the stem is used in a cementless fixation scenario.

  • How do I identify the correct regulatory clearance for this device, and what does it mean for my purchase?

    The SP-CL Hip Stem and LCU Hip System holds FDA 510(k) clearance (K213770) under the product code LZO and is also compliant with the EU MDR. The 510(k) clearance indicates it is deemed *substantially equivalent* to a legally marketed predicate device, while MDR compliance ensures it meets EU safety and performance standards. Always verify local regulatory requirements before purchasing or using.