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United Orthopedic Corporation

Taiwan·TW-MF-000009523

Last updated September 17, 2026

About

United Orthopedic Corporation is a leading international designer, manufacturer, and distributor of orthopedic implant solutions that have made life better for hundreds of thousands of people needing total hip and knee replacements.

From the manufacturer's own website. Source

What United Orthopedic Corporation makes

United Orthopedic Corporation manufactures orthopedic implant solutions including non-constrained polyethylene acetabular liners, acetabular orthopedic reamers, orthopedic bone screws, and orthopedic implant impactors. Their specific product systems include the USTAR II System, U2 Acetabular Components, UKNEE Total Knee System, UTS Hip Stem, UTF Hip Stem, and United DM Acetabular System.

The company's portfolio includes devices classified as Class I, Class II, Class III, Class IIa, and Class IIb, and is listed in the eudamed and fda_510k registries. United Orthopedic Corporation is based in Taiwan.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What orthopedic devices does United Orthopedic Corporation manufacture?

Where is United Orthopedic Corporation based?

United Orthopedic Corporation is based in Taiwan, as indicated by the country code 'TW' in their device data. The company operates as an international designer, manufacturer, and distributor of orthopedic implant solutions.

Which regulatory registries list United Orthopedic Corporation's devices?

United Orthopedic Corporation's devices are listed in the eudamed and fda_510k registries. These registries track medical devices in the European Union and United States respectively, allowing for regulatory oversight and transparency.

How are United Orthopedic Corporation's devices classified?

United Orthopedic Corporation's devices are classified into multiple risk categories: Class I, Class II, Class III, Class IIa, and Class IIb. This classification system indicates the level of control needed to ensure the safety and performance of each device type.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: Taiwan
Address: No. 16, Luke 1st Rd., Luzhu Dist., Kaohsiung City, Taiwan, Kaohsiung, Taiwan
Website: www.unitedorthopedic.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Fang-Yuan Ho
EUDAMED SRN: TW-MF-000009523
FDA FEI Number: 3012329926
DUNS Number: —

Catalogue (4313)

Page 3 of 87

Device	Model / Reference	Registries	Class	Status
U1 Total Hip System	9201-2201-RB	EUDAMEDFDA UDI	Class I	Active
UTS Hip Stem	9116-6002	EUDAMEDFDA UDI	Class I	Active
UTF Hip Stem	9106-8702	EUDAMEDFDA UDI	Class I	Active
U2 Acetabular Components	1406-7247	EUDAMEDFDA UDI	Class III	Active
UTF Hip Stem	9106-5302	EUDAMEDFDA UDI	Class I	Active
DM Acetabular System	9207-4305-RA	EUDAMEDFDA UDI	Class I	Active
UTS Hip Stem	9116-6008	EUDAMEDFDA UDI	Class I	Active
Cement Spacer Mold	9909-1101	EUDAMEDFDA UDI	Class I	Active
UTF Hip Stem	9106-1301-RC	EUDAMEDFDA UDI	Class I	Active
U2 Acetabular Components	1403-1256	EUDAMEDFDA UDI	Class III	Active
U2 Acetabular Components	1406-7366	EUDAMEDFDA UDI	Class III	Active
U2 Acetabular Components	5201-6760	EUDAMEDFDA UDI	Class IIb	Active
DM Acetabular System	1307-2056	EUDAMED	Class IIa	Active
UKNEE Total Knee System	9401-7008	EUDAMEDFDA UDI	Class I	Active
UKNEE Total Knee System	9401-4201	EUDAMEDFDA UDI	Class IIa	Active
U2 Acetabular Components	1406-7764	EUDAMEDFDA UDI	Class III	Active
U2 Acetabular Components	1403-1146	EUDAMEDFDA UDI	Class III	Active
U2 Acetabular Components	1303-1644	EUDAMEDFDA UDI	Class III	Active
UTS Hip Stem	9116-5023	EUDAMEDFDA UDI	Class IIa	Active
Revision Head	1204-6828	EUDAMED	Class IIa	Active
USTAR II Hip System	9115-1102	EUDAMEDFDA UDI	Class I	Active
UTF Hip Stem	9106-6704	EUDAMEDFDA UDI	Class I	Active
UKNEE Total Knee System	9401-4205	EUDAMEDFDA UDI	Class IIa	Active
UKNEE Total Knee System	9401-5305-RA	EUDAMEDFDA UDI	Class I	Active
UTF Hip Stem	9106-6303	EUDAMEDFDA UDI	Class I	Active
U2 Knee Modular Disposable Trial	2104-2265	EUDAMEDFDA UDI	Class IIa	Active
UTF Hip Stem	9106-6312	EUDAMEDFDA UDI	Class I	Active
U2 Knee Modular Disposable Trial	2104-2115	EUDAMEDFDA UDI	Class IIa	Active
U2 Knee Modular Disposable Trial	2104-2240	EUDAMEDFDA UDI	Class IIa	Active
U2 Knee Modular Disposable Trial	2304-2440	EUDAMEDFDA UDI	Class IIa	Active
U2 Acetabular Components	9203-4135-RA	EUDAMEDFDA UDI	Class IIa	Active
United Hip and Knee Non-sterile Reusable Instruments	9901-8104-RK	EUDAMEDFDA UDI	Class I	Active
USTAR II Hip System	1115-1415	EUDAMEDFDA UDI	Class III	Active
U2 Acetabular Components	1303-5656	EUDAMEDFDA UDI	Class III	Active
UTS Hip Stem	9116-2001	EUDAMEDFDA UDI	Class I	Active
UTS Hip Stem	9116-6099	EUDAMEDFDA UDI	Class I	Active
U2 Acetabular Components	1406-7360	EUDAMEDFDA UDI	Class III	Active
U2 Acetabular Components	1403-1368	EUDAMEDFDA UDI	Class III	Active
U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella	K243656	FDA 510(k)	Class II	Active
United U2 Xpe Total Knee System	K103733	FDA 510(k)	Class II	Active
U2 Total Knee System - Psa Type, Offset Stem Adapter	K131116	FDA 510(k)	Class II	Active
U2 Total Knee System-PF+	K221705	FDA 510(k)	Class II	Active
U2 Bipolar Implant and 22mm Femoral Head	K152439	FDA 510(k)	Class II	Active
U2 Total Knee System, PSA Tibial Insert	K161360	FDA 510(k)	Class II	Active
E-XPE Acetabular Components and U-Motion II Acetabular Cup	K172833	FDA 510(k)	Class II	Active
United U2 Femoral Component, Ps, #7	K120507	FDA 510(k)	Class II	Active
Utf Stem, Reduced	K123550	FDA 510(k)	Class II	Active
U-Motion II Acetabular System— Additional sizes	K170089	FDA 510(k)	Class II	Active
United U2 femoral head, 22mm delta ceramic head	K221675	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Conformity Stem Extension Line	K242249	FDA 510(k)	Class II	Active

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