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United U2 Femoral Head, 22mm Delta Ceramic Head

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K221675Ref 1206-2128-RBRef 1206-2232-RBRef 1206-2828-RCRef 1206-2126-RBRef 1206-2028-RC

by United Orthopedic Corporation

Identity

Trade Name
U2 Femoral Head EUDAMEDFDA UDI
Generic Name
Femoral head prosthesis trial FDA UDI
Device Name
U2 Femoral head trial, Ø26mm, +0mm EUDAMEDFDA UDI
U2 Femoral head trial, Ø28mm, +0mm EUDAMEDFDA UDI
U2 Femoral head trial, Ø28mm, +10mm EUDAMEDFDA UDI
U2 Femoral head trial, Ø32mm, +2.5mm EUDAMEDFDA UDI
U2 Femoral head trial, Ø28mm, -3mm EUDAMEDFDA UDI
Model / Reference
1206-2126-RB EUDAMEDFDA UDI
1206-2128-RB EUDAMEDFDA UDI
1206-2828-RC EUDAMEDFDA UDI
1206-2232-RB EUDAMEDFDA UDI
1206-2028-RC EUDAMEDFDA UDI
Description
U2 Femoral head trial, Ø26mm, +0mm FDA UDI
U2 Femoral head trial, Ø28mm, +0mm FDA UDI
U2 Femoral head trial, Ø28mm, +10mm FDA UDI
U2 Femoral head trial, Ø32mm, +2.5mm FDA UDI
U2 Femoral head trial, Ø28mm, -3mm FDA UDI

Identifiers

Catalog Number
1206-2126-RB FDA UDI
1206-2128-RB FDA UDI
1206-2828-RC FDA UDI
1206-2232-RB FDA UDI
1206-2028-RC FDA UDI
Primary DI / UDI-DI
04711605580953 EUDAMEDFDA UDI
04711605580960 EUDAMEDFDA UDI
04711605587044 EUDAMEDFDA UDI
04711605581004 EUDAMEDFDA UDI
04711605586818 EUDAMEDFDA UDI
Basic UDI-DI
B-04711605580960 EUDAMED
B-04711605581004 EUDAMED
B-04711605587044 EUDAMED
B-04711605580953 EUDAMED
B-04711605586818 EUDAMED
510(k) Number
K221675 FDA 510(k)
K162957 FDA UDI
FDA Product Code
LPH FDA 510(k)FDA UDI
EMDN Code
L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
GMDN Term
Femoral head prosthesis trial FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3358 FDA 510(k)
Regulation Number
888.3358 FDA 510(k)FDA UDI
Market of Registration
France EUDAMED
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

The United U2 Femoral Head, 22mm Delta Ceramic Head is a Prosthesis, Hip, Semi-constrained, Metal/Polymer, Porous Uncemented femoral component designed for hip arthroplasty. It features a 22mm delta ceramic head intended for uncemented fixation in total hip replacement procedures, providing a size extension to existing femoral head implants.

This device is supplied sterile and intended for single-use in orthopedic surgical settings. It is classified under product code LPH and has received FDA 510(k) clearance and MDD authorization, with a Special Controls designation. The implant is manufactured by United Orthopedic Corporation and must be stored according to manufacturer instructions to maintain sterility and performance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: United U2 femoral head, 22mm delta ceramic head, United U2 femoral head, 22mm delta ceramic head — FDA K221675, K221675 - United U2 femoral head | FDA 510 (k), United U2 femoral head, 22mm delta ceramic head

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
United Orthopedic Corporation

Sources (11)

  • FDA 510(k) K221675 24 fields · synced Oct 6, 2026
  • FDA UDI 5ef6e4e0-c322-4c50-abcd-4091ef0f3404 37 fields · synced May 29, 2026
  • FDA UDI cd45ab64-b4af-40e8-ba34-bc245fc6e5a0 37 fields · synced May 30, 2026
  • FDA UDI 09a4f1c3-e46a-4da9-9f2b-44be05fc4a9a 36 fields · synced May 30, 2026
  • FDA UDI ccce262b-af92-4250-8a4c-1655145e3cc1 37 fields · synced May 30, 2026
  • FDA UDI 0a3e6570-e8f8-4062-a1e6-b373cbeced8d 36 fields · synced May 30, 2026
  • EUDAMED 72651ca1-0f65-4ddf-9b9e-bfd73aced591 61 fields · synced Jul 10, 2026
  • EUDAMED 2cea0c94-a552-4b50-b5ad-178f279de6ca 61 fields · synced Jul 10, 2026
  • EUDAMED e3138358-12bb-4662-a20f-1be155349c1b 61 fields · synced Jul 15, 2026
  • EUDAMED 6ae00246-e63c-4938-96fb-1dbd85ca2694 61 fields · synced Jul 15, 2026
  • EUDAMED 3e3819f3-415f-4a04-88e6-42e48cd59827 61 fields · synced Aug 4, 2026