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:

1. Non-inflammatory degenerative joint disease such as osteoathritis, 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.
  This device is a single use implant and intended for cementless use only.

Device Description

The U2 Hip Stem, Ti plasma spray is composed of a metallic femoral stem, which is designed to articulate with commercially available U1 and U2 acetabular components and They are manufactured from titanium alloy (ASTM F620). The stems femoral heads. are designed to provide secure fit and fixation in revision hip arthroplasty for anteroposterior bone loss, calcar area defects, metaphyseal bone loss situation. The U2 Hip Stem have a 130° neck angle and Morse taper to receive modular femoral heads. The U2 Hip Stem are available in with collar and collarless types. Each type is available in two lengths, 180mm and 230mm, and 7 diameters: 11mm, 12mm, 13mm, 14mm, 15mm, 16.5mm, 18mm. Distally, the stem is cylindrical with a polished bullet shape tip. The 180mm U2 Hip Stem is available as a straight stem, the 230mm femoral stem has an anterior bow for left and right specific applications. The U2 Hip Stem are fully coated with CP Ti (ASTM F1580). The coating is sprayed with CP Ti powder in thickness 500 um +/-100 um using 200~350 um powder to establish a rough surface for press-fit fixation. This device is a single use implant and intended for cementless use only.

AI/ML Overview

This 510(k) summary (K062978) for the U2 Hip Stem, Ti Plasma Spray, does not contain specific acceptance criteria or details of a study proving the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity, as would be expected for an AI/ML powered device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices based on materials, design, and indications for use. For medical implants like this hip stem, the "acceptance criteria" primarily relate to demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through characterization of its mechanical properties, biocompatibility, and manufacturing processes, rather than performance metrics measured against a ground truth.

Therefore, many of the requested categories related to AI/ML device studies (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of traditional medical device submission.

Here's a breakdown of the information that is available or implied in the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied for Substantial Equivalence): The primary "acceptance criteria" for a 510(k) submission for this type of device is demonstrating substantial equivalence to predicates. This means showing that the U2 Hip Stem is as safe and effective as the predicate devices, the Reach® Hip Stem, Ti plasma spray (K000760) and United U2 HA/Ti Plasma Spray (K003237). This is typically achieved by demonstrating comparable performance in areas like:
- Material composition (ASTM F620 titanium alloy, CP Ti coating per ASTM F1580).
- Design features (130° neck angle, Morse taper, cylindrical distal stem, collar/collarless options, lengths, diameters, anterior bow for 230mm stem).
- Intended Use/Indications (same clinical conditions as predicates).
- Mechanical properties, fatigue strength, and wear characteristics (though not detailed in this summary, these would be evaluated in the full submission).
- Biocompatibility of materials.
- Manufacturing processes (implicitly assessed for consistency and quality).
Reported Device Performance: The summary states: "Features comparable to predicate devices, United U2 HA/Ti Plasma Spray (K003237), Reach® Hip Stem, Ti Plasma Spray (K000760), include same materials, design and indications." This is the core "performance" claim for substantial equivalence. No specific quantitative performance metrics (e.g., in vivo survival rates, specific biomechanical test results) are provided in this summary document beyond the physical characteristics.

Regarding items 2-7 (which are primarily relevant for AI/ML device studies):

These items are not applicable to this 510(k) submission for a mechanical implant. This document is a summary for a traditional medical device, not an AI/ML software device or diagnostic tool. Therefore, there's no discussion of test sets, training sets, ground truth derived from experts or pathology, or multi-reader studies.

However, to address them directly for completeness:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* N/A. This device is a mechanical implant, not an AI/ML diagnostic tool requiring a test set of data. Substantial equivalence is typically proven through bench testing, material characterization, and comparisons to predicate device designs and indications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
* N/A. No expert ground truth establishment for a diagnostic test set.

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

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
* N/A.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* N/A. The "ground truth" for this device type would be established standards for implant design, material science, and biocompatibility, as well as clinical experience with similar predicate devices.

8. The sample size for the training set
* N/A. This is not an AI/ML device.

9. How the ground truth for the training set was established
* N/A. This is not an AI/ML device.

Summary

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K062978

Summary

510(k) Summary of Safety and Effectiveness

JAN 1 6 2007

Company:	United Orthopedic Corporation
Address:	No 57, Park Ave. 2, Science Park, Hsinchu, 300, Taiwan
Phone Number:	886-3-5773351
Fax Number:	886-3-5777156
Date Prepared:	September 28, 2006.

Device Name:	U2 Hip stem, Ti plasma spray
Common Name:	Cementless hip stem
Classification Name:	Hip joint femoral (hemi-hip) metallic cemented or uncementedprosthesis (888.3360)
Predicate Device:	Reach® Hip Stem, Ti plasma spray (K000760)United U2 HA/Ti Plasma Spray (K003237)

Device Description:

The U2 Hip Stem, Ti plasma spray is composed of a metallic femoral stem, which is designed to articulate with commercially available U1 and U2 acetabular components and They are manufactured from titanium alloy (ASTM F620). The stems femoral heads. are designed to provide secure fit and fixation in revision hip arthroplasty for anteroposterior bone loss, calcar area defects, metaphyseal bone loss The U2 Hip Stem have a 130° neck angle and Morse taper to receive modular situation. The U2 Hip Stem are available in with collar and collarless types. Each femoral heads. type is available in two lengths, 180mm and 230mm, and 7 diameters: 11mm, 12mm, 13mm, 14mm, 15mm, 16.5mm, 18mm. Distally, the stem is cylindrical with a polished bullet shape tip. The 180mm U2 Hip Stem is available as a straight stem, the 230mm femoral stem has an anterior bow for left and right specific applications. The U2 Hip Stem are fully coated with CP Ti (ASTM F1580). The coating is sprayed with CP Ti powder in thickness 500 um +/-100 um using 200~350 um powder to establish a rough surface for press-fit fixation. This device is a single use implant and intended for cementless use only.

Intended 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:

1. Non-inflammatory degenerative joint disease such as osteoathritis, 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.

This device is a single use implant and intended for cementless use only.

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છ U2 HIP STEM, Ti Plasma Spray

Basis for Substantial Equivalence:

Features comparable to predicate devices, United U2 HA/Ti Plasma Spray (K003237), Reach® Hip Stem, Ti Plasma Spray (K000760), include same materials, design and indications.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract design of an eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

United Orthopedic Corporation % Mr. Gene Huang Regulatory Affairs Coordinator No. 57. Park Avenue 2, Science Park Hsinchu, Taiwan 300

JAN 16 2007

Re: K062978 Trade/Device Name: U2 Hip Stem, Ti Plasma Spray Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: LWJ Dated: December 28, 2006 Received: January 3, 2007

Dear Mr. Huang:

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 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); good manufacturing practice requirements as set

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Page 2 - Mr. Gene Huang

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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Soubey Brichum

Mark N. Melk erson 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):____________________________________________________________________________________________________________________________________________________ K062978

Device Name: _ U2 Hip stem, Ti plasma spray

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 osteoathritis, 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. This device is a single use implant and intended for cementless use only.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara huchins

vision Sion Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number Ka 2978

Regulation Number and Section

§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.