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Conformity Stem Extension Line #0

by United Orthopedic Corporation

510(k) K243466Ref 9110-6005-RA, 9110-6009-RB, 9110-8305, 9110-6000-RB, 9110-5040-RC, 9110-6000, 9110-1102, 9110-1301-RT, 9110-1502

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 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) K243466↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number471987216TD-Ir-003F4 Basic UDI-DI Date18 Feb 2025RegisteredStatusActive
European UnionCE/MDR EUDAMED Number471987216TD-Ir-003F4 Basic UDI-DI Date18 Feb 2025RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK243466 Date6 Jan 2025ClearedStatusActive
United StatesGUDID listing GUDID Number04719872144335 UDI-DI Date28 Jun 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Conformity Stem
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable
Orthopaedic broach
Instrument tray, reusable
Surgical instrument handle, non-torque-limiting
Femoral stem prosthesis trial
Device Name
United Hip and Knee Non-sterile Reusable Instruments
Model / Ref / Catalog
9110-1102, 9110-6000, 9110-8305, 9110-6005-RA, 9110-1301-RT, 9110-6000-RB, 9110-5040-RC, 9110-6009-RB, 9110-1502
Primary DI / UDI-DI
04719872144335, 04719886903515, 04719872145608, 04719872142942, 04711605587495, 04719886903539, 04711605586641, 04719886896152, 04711605587518
Basic UDI-DI
471987216TD-Ir-003F4, B-04711605586641
Direct Marketing DI
04719872142942
04719886896152
04719872145608
04719886903539
04719886903515
04719872144335
04711605587495
04711605587518
510(k) Number
FDA Product Code
LZO, LXH, MEH, JDI, KWY
EMDN Code
L091202, L091199, L091104
GMDN Term
Orthopaedic inorganic implant inserter/extractor, reusable
Orthopaedic broach
Instrument tray, reusable
Surgical instrument handle, non-torque-limiting
Femoral stem prosthesis trial
Device Class
Class I EUDAMEDGUDID
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 888.3353 510(k)GUDID
888.4540 GUDID
888.3350 GUDID
888.3390 GUDID
EU market of registration
France
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
510(k) NumberEUDAMED
—
510(k)
K243466
GUDID
K183312
K191056
Device ClassEUDAMED
Class I
Class IIa
510(k)
Class II
GUDID
Class I
Class II

Overview

AI-generated summary, 18 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 Conformity Stem Extension Line #0 is a modular orthopedic implant component designed to extend the length of femoral stems in total hip arthroplasty procedures. It is classified as a stem extension device, intended for use in conjunction with primary or revision hip implants to achieve proper leg length and alignment during surgery.

This device is supplied sterile and intended for single-use. It is manufactured by United Orthopedic Corporation and is approved under FDA 510K clearance (K243466), MDD, and MDR regulations. The product is available in a single reference (#0) and must be handled in accordance with sterile surgical protocols. No MRI safety information is specified.

Other devices from United Orthopedic Corporation

See all devices from United Orthopedic Corporation →

Questions

AI-generated answers, 18 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 primary purpose of the Conformity Stem Extension Line #0 in hip replacement surgery?

    The Conformity Stem Extension Line #0 is designed to extend the length of femoral stems during total hip arthroplasty procedures. It helps achieve proper leg length and alignment, which is critical for restoring function and stability after surgery. This modular component is specifically intended for use with primary or revision hip implants.

  • Is this device reusable, or is it meant for single-use only?

    The Conformity Stem Extension Line #0 is explicitly intended for single-use only. Since it is supplied sterile, it must be used once per patient and then discarded to maintain sterile surgical protocols and prevent contamination.

  • How many sizes or models of this device are available, and how do I identify the correct one?

    The Conformity Stem Extension Line is available in a single reference model, labeled as #0. There are no additional sizes or variants listed, so this is the only option for extending femoral stems in the specified procedures.

  • What regulatory approvals does this device hold, and how does that affect its use?

    The Conformity Stem Extension Line #0 is approved under FDA 510(k) clearance (K243466), as well as under the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). These approvals confirm that the device meets regulatory standards for safety and performance in its intended use, ensuring compliance with U.S. and EU requirements when used as specified.

  • How should I store this device to ensure it remains sterile and functional?

    Since the Conformity Stem Extension Line #0 is supplied sterile, it must be stored in its original packaging until ready for use. The packaging should be kept sealed and protected from contamination, moisture, or physical damage. Always follow the manufacturer’s instructions for sterile storage to maintain its integrity before surgery.

Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt YesGUDIDNoGUDID
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No