This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

For use as a Total Hip Replacement

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

For use as a Bipolar Hip Replacement

Femoral head/neck factures or non-unions.
Aseptic necrosis of the femoral head.
Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Cemented stem is designed for cemented use only.

Device Description

The U2 Hip System for hip arthroplasty is a metal/polymer/metal semi-constrained prosthesis with femoral components and acetabular components. The femoral components are composed of a ball mechanical locked with a stem by means of a Morse taper, while the acetabular components are composed of an highly crosslinked ultra - high - molecular - weight - polyethylene articulating bearing surface fixed in a metal shell. Components of this premarket notification include the following components:

Ti Porous Coated Cup
XPE Cup Liner
32 mm and 36 mm Femoral Head
U2 Hip Stem, Press-fit
U2 Hip Stem, Cemented

The titanium bar (ASTM F136) was forged into a net-shape of acetabular cup and then the forged part was machined into the final shape of Ti Porous Coated Cup. The outer surface is porous coated with three layers of CP Ti beads (ASTM F1580). XPE Cup Liner is manufactured from highly crosslinked UHMWPE which conform to ASTM F2565 and the UHMWPE raw material is in accordance with ASTM F648 and ISO 5834. The first series of XPE Cup Liner with the sizes of 44 to 80 mm has an inner diameter of 28 mm. The second series with the sizes of 50 to 80 mm have an inner diameter of 32 mm. The third series with the sizes from 54 to 80 mm have an inner diameter of 36 mm. The 32 and 36 mm Femoral Head is manufactured from CoCrMo alloy (ASTM F1537) with neck length of -3, +0, +5, and +10 mm. U2 Press-fit Stem is manufactured from titanium alloy (ASTM F620) which is intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. U2 Cemented Hip Stem manufactured from forging CoCrMo alloy (ASTM F799) is intended for cement fixation. Moreover, this device is available to use with an accessory, called "Cement Restrictor, Full PE" made of Ultra-High Molecular Weight Polyethylene (ASTM F648).

The Ti Porous Coated Cup will be used with 510k cleared cup liner of the U2 Acetabular Component (K050262) and currently submission XPE Cup Liner. As using with the existing cup liner (K050262), the Ti Porous Coated Cup may be used with 26 mm and 28 mm Femoral Head (K994078 and K022520) and 28 mm Ceramic Femoral Head (K103479). As using with currently submission XPE Cup Liner, this component may be used with currently submission 32 mm and 36mm Femoral Head, the 28 mm Femoral Head (K022520) and 28 mm and 32 mm Ceramic Femoral Head (K103479). Besides, XPE Cup Liner may also be used with existing U2 Acetabular Cup (K050262). The 32 mm and 36 mm Femoral Head may also be used with U2 Bipolar Implant (K101670), Revision Stem (K062978) and current submission Cemented Stem and Press-fit Stem.

The Press-fit Stem and Cemented Stem will be used with currently submission 32mm and 36 mm metal Femoral Head and may be used with 26 mm and 28 mm metal Femoral Head (K994078 and K022520). The Press-fit Stem which made from Ti alloy can also be used with Ceramic Femoral Head (K103479).

AI/ML Overview

The provided text describes the U2 Hip System, a semi-constrained hip prosthesis. It details the device components, materials, and indications for use. The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of design, operational principles, material composition, and extensive bench performance tests. There is no information about acceptance criteria or a study proving the device meets acceptance criteria in the sense of clinical performance or diagnostic accuracy. Instead, the "performance test - bench" section outlines mechanical tests conducted to ensure the device's safety and effectiveness regarding its physical properties and mechanical integrity.

Here's an analysis based on the provided text, addressing the user's questions where applicable, and noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as pass/fail thresholds for clinical performance or diagnostic accuracy. Instead, it describes mechanical tests performed to demonstrate the device's ability to withstand expected in vivo loading. The "reported device performance" is that these tests were performed and a "review of the mechanical data indicates that the U2 Hip System is capable of withstanding expected in vivo loading without failure." No specific numerical results of these tests and their comparison against predefined limits are provided in this summary.

Here's a summary of the tests performed and the general conclusion:

Test Performed	Reported Device Performance
Locking Strength of XPE Cup Liner per ASTM F1820	Mechanical data indicates capability of withstanding expected in vivo loading without failure.
Wear Simulation Test of XPE Cup Liner per ISO 14242-1	Mechanical data indicates capability of withstanding expected in vivo loading without failure.
Range of Motion for XPE Cup Liner and 32 and 36 mm Femoral Head by CAD simulation	Mechanical data indicates capability of withstanding expected in vivo loading without failure.
Femoral Head Disassembly loads for the Subject Stem per ASTM F2009	Mechanical data indicates capability of withstanding expected in vivo loading without failure.
Stem Fatigue Test for Press-fit Stem and Cemented Stem with Torsion per ISO 7206-4 and ASTM F1612	Mechanical data indicates capability of withstanding expected in vivo loading without failure.
Neck Fatigue Test for Press-fit Stem and Cemented Stem with Torsion per ISO 7206-6	Mechanical data indicates capability of withstanding expected in vivo loading without failure.
Evaluation of modified surface treatment (SEM, shear fatigue, static shear, static tensile, taber abrasion resistance)	Mechanical data indicates capability of withstanding expected in vivo loading without failure.
Characterization of material properties of XPE cup liner (tensile, ultimate load, Izod impact, fatigue crack propagation, thermal, residual free radicals, swell ratio, oxidation index, trans-vinylene index)	Mechanical data indicates capability of withstanding expected in vivo loading without failure.

The document states: "A review of these tests has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices."

2. Sample size used for the test set and the data provenance

Not applicable. The study described is a series of bench performance tests on the device's components, not a clinical trial or a study involving human subjects or data. Therefore, there is no "test set" in the context of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical device (hip prosthesis), and the "study" involves mechanical testing, not interpretation of data by experts for ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is a medical device (hip prosthesis) and the "study" involves mechanical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document pertains to a medical device (hip prosthesis), not an AI algorithm or a diagnostic tool that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This document pertains to a medical device (hip prosthesis), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the conventional sense of diagnostic accuracy studies. For mechanical tests, the "ground truth" is defined by the objective physical properties and performance characteristics as measured against established ASTM and ISO standards for medical implants. The tests themselves are designed to evaluate whether the components meet these engineering standards for safety and effectiveness.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning algorithm.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" as this is not an AI/machine learning algorithm.

Additional Information from the document:

Clinical Data: "Clinical data was not needed to support the safety and effectiveness of the subject devices." This implies that the substantial equivalence argument was entirely based on non-clinical (bench) testing and comparison to predicate devices.
Regulatory Basis: The 510(k) was prepared in accordance with several FDA guidance documents for hip joint prostheses and orthopedic implants, reinforcing that the testing conducted (as detailed in the "Performance Test - Bench" section) is the accepted method for demonstrating safety and effectiveness for this type of device.

Summary

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( U2 Hip System

510(k) Summary

510(k) Summary of Safety and Effectiveness

Submitted by:	United Orthopedic Corporation
Address:	No.57, Park Ave 2, Science Park, Hsinchu 300, Taiwan
Phone Number:	+886-3-5773351 ext. 212
Fax Number:	+886-3-577156
Date of Summary:	June 01, 2011
Contact Person:	Fang-Yuan HoManager, Regulatory Affairs
Proprietary Name:	U2 Hip System
Common Name:	Semi-constrained total hip prostheses
Device ClassificationName and Reference:	Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesis under 21CFR 888.3358This falls under the Orthopedics panel.
Device Class	Class II
Panel Code	Orthopaedics Device
Device Product Code:	LPH, JDI
Predicate Device:	1. "Smith & Nephew" R3 Acetabular Cup System (K070756)2. "UNITED" Femoral Head (K022520, K994078)3. "Osteonics" Crossfire System Acetabular Insert (K993352)4. "Smith & Nephew" Synergy Hip System-Press Fit (K061066)5. "Smith & Nephew" Synergy Cemented Hip Stem (K990369)6. "Zimmer" Intramedullary Bone Plug (K001733)

Device Description:

for hip arthroplasty is a metal/polymer/metal System designed U2 Hip

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ਤ U2 Hip System

semi-constrained prosthesis with femoral components and acetabular components. The femoral components are composed of a ball mechanical locked with a stem by means of a Morse taper, while the acetabular components are composed of an highly crosslinked ultra - high - molecular - weight - polyethylene articulating bearing surface fixed in a metal shell. Components of this premarket notification include the following components:

Ti Porous Coated Cup
XPE Cup Liner
32 mm and 36 mm Femoral Head
U2 Hip Stem, Press-fit
U2 Hip Stem, Cemented

The titanium bar (ASTM F136) was forged into a net-shape of acetabular cup and then the forged part was machined into the final shape of Ti Porous Coated Cup. The outer surface is ' porous coated with three layers of CP Ti beads (ASTM F1580). XPE Cup Liner is manufactured from highly crosslinked UHMWPE which conform to ASTM F2565 and the UHMWPE raw material is in accordance with ASTM F648 and ISO 5834. The first series of XPE Cup Liner with the sizes of 44 to 80 mm has an inner diameter of 28 mm. The second series with the sizes of 50 to 80 mm have an inner diameter of 32 mm. The third series with the sizes from 54 to 80 mm have an inner diameter of 36 mm. The 32 and 36 mm Femoral Head is manufactured from CoCrMo alloy (ASTM F1537) with neck length of -3, +0, +5, and +10 mm. U2 Press-fit Stem is manufactured from titanium alloy (ASTM F620) which is intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. U2 Cemented Hip Stem manufactured from forging CoCrMo alloy (ASTM F799) is intended for cement fixation. Moreover, this device is available to use with an accessory, called "Cement Restrictor, Full PE" made of Ultra-High Molecular Weight Polyethylene (ASTM F648).

The Ti Porous Coated Cup will be used with 510k cleared cup liner of the U2 Acetabular

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< 1154

ਹੈ U2 Hip System

510(k) Summary

Component (K050262) and currently submission XPE Cup Liner. As using with the existing cup liner (K050262), the Ti Porous Coated Cup may be used with 26 mm and 28 mm Femoral Head (K994078 and K022520) and 28 mm Ceramic Femoral Head (K103479). As using with currently submission XPE Cup Liner, this component may be used with currently submission 32 mm and 36mm Femoral Head, the 28 mm Femoral Head (K022520) and 28 mm and 32 mm Ceramic Femoral Head (K103479). Besides, XPE Cup Liner may also be used with existing U2 Acetabular Cup (K050262). The 32 mm and 36 mm Femoral Head may also be used with U2 Bipolar Implant (K101670), Revision Stem (K062978) and current submission Cemented Stem and Press-fit Stem

Indications for Use:

This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

For use as a Total Hip Replacement

1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
1. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
1. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

For use as a Bipolar Hip Replacement

1. Femoral head/neck factures or non-unions.
1. Aseptic necrosis of the femoral head.

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K111546

g U2 Hip System

1. Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
  Cemented stem is designed for cemented use only.

Basis for Substantial Equivalence:

The substantial equivalence of the U2 Hip System is based on its similarities in indications for use, design features, operational principles, and material composition to the predicate systems listed in the table below.

Current Subject	Predicate Systems	Manufacture	SubmissionNumber	DecisionDate
Ti Porous Cup	R3 ACETABULARCUP SYSTEM	Smith &Nephew, Inc.	K070756	06/06/2007
XPE Cup Liner	Crossfire SystemAcetabular Insert	Osteonics	K993352	11/19/1999
32mm and 36 mm	26mm Femoral Head	UnitedOrthopedic Co.	K022520	02/25/2003
Femoral Head	28mm Femoral Head	UnitedOrthopedic Co.	K994078	12/04/2000
Press-fit Stem	SYNERGY HIPSYSTEM-Press FitStem	Smith &Nephew, Inc.	K061066	07/14/2006
Cemented Stem	Synergy CementedHip Stem	Smith &Nephew, Inc.	K990369	03/12/1999
Cement Restrictorfor CementedStem	Intramedullary BonePlug	Zimmer	K001733	06/20/2000

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9 U2 Hip System

Performance Test - Bench:

This 5101k) was prepared in accordance with the Agency's, " Class II Special Controls Guidance Document- Hip Joint Metal Polymer Constrained Cemented or Uncemented Prosthesis", "Guidance for Non-clinical Information for Femoral Stem Prostheses", "Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Components" and "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement". A review of the mechanical data indicates that the U2 Hip System is capable of withstanding expected in vivo loading without failure. The following mechanical tests of the U2 Hip System were performed:

Locking Strength of XPE Cup Liner per ASTM F1820 ●
Wear Simulation Test of XPE Cup Liner per ISO 14242-1 ●
Range of Motion for XPE Cup Liner and 32 and 36 mm Femoral Head by CAD ● simulation
Femoral Head Disassembly loads for the Subject Stem per ASTM F2009 .
Stem Fatigue Test for Press-fit Stem and Cemented Stem with Torsion per ISO . 7206-4 and ASTM F1612
Neck Fatigue Test for Press-fit Stem and Cemented Stem with Torsion per ISO ● 7206-6
Evaluation of modified surface treatment includes SEM evaluation per ASTM ● F1854, shear fatigue testing per ASTM F1160, static shear testing per ASTM F1044, static tensile testing per ASTM F1147, and taber abrasion resistance per ASTM F1978
Characterize of material properties of XPE cup liner includes tensile properties per . ASTM D638, ultimate load per ASTM F2183, Izod impact strength per ASTM F648, Annex 1, fatigue crack propagation per ASTM E647, thermal properties (i.e. % crystallinity and melting temperature) per ASTM D3418, residual free radicals via ESR, swell ratio per ASTM F2214, oxidation index (OI) per ASTM F2102,

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K11546

9 U2 Hip System

and trans-vinylene index (TVI) per ASTM F2381.

A review of these tests has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.

Conclusion

As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the U2 Hip System. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to predicate hip systems.

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

United Orthopedic Corporation % Fang-Yuan Ho Regulatory Affairs Manager 57 park Ave. 2, Sience Park Hsinchu, China (Taiwan) 300

JUL - 1 2011

Re: K111546 Trade Name: U2 Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH. JDI Dated: June 1, 2011 Received: June 3, 2011

Dear Fang-Yuan Ho:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Fang-Yuan Ho

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm1 for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Fr. Peter D'Souza

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use

510 (k) Number (if known): _ Kil 5 حالا 5 الليك الليك الليك

Device Name:

Indications for Use:

This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

For use as a Total Hip Replacement

1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
1. Revision of pervious unsuccessful femoral head replacement, cup arthroplasty or other procedure.
1. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

For use as a Bipolar Hip Replacement

l . Femoral head/neck factures or non-unions.
1. Aseptic necrosis of the femoral head.
1. Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Cemented stem is designed for cemented use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

. Melkersson

(Division/Sign-Oft)
Division of Surgical, Orthopedic,
and Restorative Devices

Page I of 1

510(k) Number K111546

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.