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:

· Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
Inflammatory degenerative joint disease such as rheumatoid arthritis;
Correction of function deformity; .
· Revision procedures where other treatments or devices have failed; and
· Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Device Description

The U2 Acetabular Cup and Femoal Head are designated as an acetabular component and femoral head and are to be used with United U1 hip stem (K994078) and U2 hip stem (K003237) of total hip replacement. It is a modular type of product system. The U2 Acetabular Cup has ten sizes of options, hemispherical design, porous-coated surface on the metallic shell, clustered bone screw holes, spherical screw holes for variable screw locking angle, PMMA cement plug, easy snap-in and take out mechanism, 12 options for angle adjustment, minimum 6.9 mm thickness of UHMWPE liner. The metallic shell is produced from cast Co-Cr-Mo alloy (ASTM F75). The plastic liner is machined from extruded UHMWPE bars (ISO 5834/I). The U2 28 mm femoral head is aimed to providing more choice for orthopaedic surgeon to perform total hip arthroplasty. The taper angle of 28 mm femoral head is identical with U1 26. mm femoral head (K994078). Therefore, U2 28 mm femoral head can be used wath our Ul and U2 hip stems. The U2 28 mm femoral head is available in -3, +0, +5, and +10 mm of neck length.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the U2 Acetabular Cup and Femoral Head, and therefore it is a submission to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria through clinical trials or software validation.

Here's an analysis of what is and isn't present in the document based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present "acceptance criteria" in the typical sense of a clinical study (i.e., specific sensitivity, specificity, accuracy targets). Instead, it presents test results for biomechanical properties and states that the device is substantially equivalent to a predicate device.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Static Tensile Strength (Porous Coating)	Substantially equivalent to predicate device (K994078)	27 MPa
Static Shear Strength (Porous Coating)	Substantially equivalent to predicate device (K994078)	67 MPa
Porosity (Porous Coating)	Substantially equivalent to predicate device (K994078)	30 to 70 percent
Pore Size (Porous Coating)	Substantially equivalent to predicate device (K994078)	100 to 1000 microns
Thickness (Porous Coating)	Substantially equivalent to predicate device (K994078)	500 to 1500 microns
Range of Motion (U2 Acetabular Cup)	Substantially equivalent to predicate device (U1 Hip System K994078)	U2 Acetabular Cup is substantial equivalent to U1 Hip System (K994078)
Locking Mechanism (Push-out Test)	Compared with U1 Hip System (K994078)	Integrity is substantial equivalent
Locking Mechanism (Lever-out Test)	Compared with U1 Hip System (K994078)	Integrity is substantial equivalent
Locking Mechanism (Torque-out Test)	Compared with U1 Hip System (K994078)	Integrity is substantial equivalent

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device. The performance metrics presented are compared against the predicate device or industry standards to support this claim.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a distinct "test set" in terms of patient data or clinical samples. The testing described (static tensile/shear strength, porosity, range of motion, biomechanical tests) refers to physical testing of the device components. The number of units tested for each biomechanical or material property is not provided.
Data Provenance: The testing appears to be laboratory-based physical/mechanical testing of the device components. It is not patient data. The manufacturer is located in Hsinchu, Taiwan, suggesting the testing was likely conducted by or for the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable as the study described is physical product testing, not an assessment requiring expert adjudication of "ground truth" using imaging or clinical data.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. The document describes physical and biomechanical testing of the device, not a comparative effectiveness study involving human readers or AI.

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

This is not applicable. The device is a physical medical implant (hip prosthesis components), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to engineering specifications, material science standards (e.g., ASTM F75 for Co-Cr-Mo alloy, ISO 5834/I for UHMWPE), and the performance characteristics of the predicate device (UNITED U1 Hip Prosthesis K994078). The physical properties and biomechanical performance of the U2 Acetabular Cup and Femoral Head were measured and compared against these established benchmarks.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical implant, not a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable.

Summary

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FFB 2 5 2003

(() U2 Acetabular Cup and Femoral Head

<022520 page lot

Summary

510(k) Summary of Safety and Effectiveness

Submitted By:	United Orthopedic CorporationNo. 57, Park Ave. 2, Science Park, Hsinchu, 300, TaiwanTel: 886-3-5773351Fax: 886-3-5777156
Date	July 24th, 2002
Contact person	Jiann-Jong Liau / Regulatory Affairs
Device Name:	U2 Acetabular Cup and Femoral head
Common Name:	Acetabular Cup and Femoral head
Classification Name and Reference:	21CFR 888.3358 Hip joint metal/polymer/metalsemi-constrained porous-coated uncemented prosthesis
Predicate Device:	UNITED U1 Hip Prosthesis (K994078)

Device Description:

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(B) U2 Acetabular Cup and Femoral Head

Intended Use:

The U2 Acetabular Cup and Femoral Head are indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
1. Inflammatory degenerative joint disease such as rheumatoid arthritis;
1. Correction of function deformity;
1. Revision procedures where other treatments or devices have failed; and
1. Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Basis for Substantial Equivalence:

Features comparable to predicate device, UNITED U1 hip prosthesis, include Co-Cr-Mo alloy substrate, beaded porous coated surface on the acetabular cup and 26 mm femoral head.

Test Results:

The static tensile and shear strength of the beaded porous coating are 27 MPa and 67 MPa respectively. The porosity of the porous coating ranges from 30 to 70 percent, the pore size ranges from 100 to 1000 microns and the thickness ranges from 500 to 1500 microns.

The range of motion of U2 Acetabular Cup is substantial equivalent to U1 Hip System (K994078).

Three biomechanical tests were performed, including push-out, lever-out and torque-out tests, to evaluate the locking mechanism of modular acetabular component. All test results are compared with U1 Hip System (K994078). The test results demonstrate that the integrity of locking mechanism between UHMWPE liner and metal acetabular shell of U2 Acetabular Cup is substantial equivalent to that of the predicate device.

Based on the previous test results, the U2 Acetabular Cup and Femoral head is substantial equivalent to UNITED U1 Hip system.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird with three human profiles incorporated into the design.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2003

Jiann-Jong Liau, Ph.D. Regulatory Affairs United Orthopedic Corporation No. 57, Park Avenue 2, Science Park Hsinchu, 300, Taiwan

Re: K022520

Trade/Device Name: U2 Acetabular Cup and Femoral Head Regulation Numbers: 21 CFR 888.3358 Regulation Names: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: November 24, 2002 Received: November 27. 2002

Dear Dr. Liau:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 docs 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); good manufacturing practice requirements as set

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Page 2 - Dr. Jiann-Jong Liau

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

h Mark McMillan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if known): K022520

Device Name: U2 Acetabular Cup and Femoral head

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:

· Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
Inflammatory degenerative joint disease such as rheumatoid arthritis;
Correction of function deformity; .
· Revision procedures where other treatments or devices have failed; and
· Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (per 21 CFR 801.109) OR

Over-The Counter Use _

for Mark N. Millner

sion of General, Restorative and Neurological Devices

510(k) Number K022520

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.