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Conformity Stem Extension Line #0

by United Orthopedic Corporation

Part of a family of 1,038 devices: see the family page

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

No date given

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↗

+2 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026.

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
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191056 Date3 Jan 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 471987216TD-Ir-003F4 registered 18 Feb 2025 Active· +1 more in the status table
  • FDA 510(k) K243466 decided 6 Jan 2025 Active· +2 more in the status table
  • FDA GUDID UDI-DI 04719872144335 listed 28 Jun 2022 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K183312
  2. Cleared FDA 510(k) K191056
  3. Listed FDA GUDID 04719872144335
  4. Cleared FDA 510(k) K243466
  5. Registered EUDAMED 471987216TD-Ir-003F4

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  • Withdrawn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 registration type
Standard device
Legacy device (under a directive)
EU market of registration
France
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
Sterilisation 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

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

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.

Devices cleared under K243466

8 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K243466
UDI-DISize and differences
Conformity Stem 9110-8301-RA
UNITED ORTHOPEDIC CORP.
9110-8301-RA / 9110-8301-RA04719886903768
Prescription: yes; Single use: no
On the market
Conformity Stem 9110-8301-RT
UNITED ORTHOPEDIC CORP.
9110-8301-RT / 9110-8301-RT04719886905533
Prescription: yes; Single use: no
On the market
Conformity Stem 9110-8315
UNITED ORTHOPEDIC CORP.
9110-8315 / 9110-831504719886904277
Prescription: yes; Single use: no
On the market
Conformity Stem 9110-8316
UNITED ORTHOPEDIC CORP.
9110-8316 / 9110-831604719886904284
Prescription: yes; Single use: no
On the market
United Hip System 1110-1000
UNITED ORTHOPEDIC CORP.
1110-100004719886901153
Prescription: no; Single use: yes
On the market
United Hip System 1110-1400
UNITED ORTHOPEDIC CORP.
1110-140004719886901160
Prescription: no; Single use: yes
On the market
United Hip System 1110-3000
UNITED ORTHOPEDIC CORP.
1110-300004719886901177
Prescription: no; Single use: yes
On the market
United Hip System 1110-5000
UNITED ORTHOPEDIC CORP.
1110-500004719886901184
Prescription: no; Single use: yes
On the market

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE.

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt YesGUDIDNoGUDID
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)