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.
Correction of functional deformity.
Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is unmanageable using other techniques.
This device is a single use implant and intended for cementless use only.

Device Description

The subject device, U-Motion II Acetabular System—Extension line, is an extension in terms of additional size to the previously cleared U-Motion II Acetabular System (K122185, K132455, K170089 and K172833). The subject device includes two components: U-Motion II Cup and U-Motion II XPE Cup liner. The indication, design rationale, material, major manufacture process and sterilization method of these two components are identical to the cleared U-Motion II Cup (K122185, K132455, K170089, and K172833) and U-Motion II XPE Cup Liner (K122185 and K170089), except for the dimension.
U-Motion II Cup
The cleared U-Motion II Cup is available from 44 through 80 mm outer diameter (O.D.) in 2 mm increments. The subject U-Motion II Cup is available in 48 mm O.D. and 54 mm O.D. and the compatible liner diameter is 36 mm and 40 mm, respectively, which is larger than the cleared cups. It is designed to only be compatible with the subject cup liner.
U-Motion II XPE Cup Liner
The cleared U-Motion II XPE Cup Liner is available in 28 mm, 32 mm, 36 mm, and 40 mm inner diameter (I.D.). The subject XPE Cup Liner is available in 36 mm I.D. and 40 mm I.D., and is compatible with the subject 48 mm O.D. cup. and 54 mm O.D. cup, respectively.

AI/ML Overview

This document is a 510(k) premarket notification for the "U-Motion II Acetabular System-Extension line," a hip joint prosthesis. It outlines the device description, indications for use, technological characteristics, and performance analysis used to establish substantial equivalence to existing predicate devices.

Here's an analysis of the provided information, identifying what's present and what's missing, especially regarding the acceptance criteria and study details you requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of acceptance criteria with quantitative thresholds for each test. Instead, it lists the types of tests conducted and states that "the test results indicated that this device is safe and effective."

Test Conducted	Result/Comment
Impingement analysis	"Indicated that this device is safe and effective." (Implicitly, the device met impingement analysis requirements)
Range of motion	"Indicated that this device is safe and effective." (Implicitly, the device met range of motion requirements)
Jumping distance analysis	"Indicated that this device is safe and effective." (Implicitly, the device met jumping distance analysis requirements)
Wear simulation test	"Indicated that this device is safe and effective." (Implicitly, the device met wear simulation test requirements)
Locking strength test	"Indicated that this device is safe and effective." (Implicitly, the device met locking strength test requirements)
Cup deformation test	"Indicated that this device is safe and effective." (Implicitly, the device met cup deformation test requirements)
Cup fatigue test	"Indicated that this device is safe and effective." (Implicitly, the device met cup fatigue test requirements)

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

Sample Size: The document does not explicitly state the sample sizes used for each of the performance tests (Impingement analysis, Range of motion, Jumping distance analysis, Wear simulation test, Locking strength test, Cup deformation test, Cup fatigue test). These generally involve a certain number of specimens for mechanical testing.
Data Provenance: The studies are described as "Verification activities on subject devices" and "tests were conducted to evaluate the safety and effectiveness of the subjected device." This indicates the studies were prospective in nature, specifically conducted for this submission. There's no explicit mention of the country of origin of the data, but the manufacturer (United Orthopedic Corporation) is located in Taiwan.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable as the device is a medical implant (hip prosthesis), and the studies described are mechanical performance tests, not analyses requiring ground truth established by medical experts (like in AI/diagnostic device studies).

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as point 3. Mechanical tests do not typically involve adjudication by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable. The device is a physical implant, not a diagnostic or AI-assisted system that would involve human readers interpreting cases. Therefore, no MRMC study or effect size comparing human readers with and without AI assistance was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This information is not applicable. The device is a physical implant, not an algorithm.

7. Type of Ground Truth Used:

This information is not applicable. As mentioned above, the tests are mechanical performance evaluations of a physical device, and the "ground truth" is defined by established engineering standards and biomechanical principles for joint prostheses.

8. Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this is a physical medical device, not an AI/machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as point 8.

Summary of what's provided and what's missing for the requested information:

Acceptance Criteria & Performance: A list of tests is provided, with a general statement of "safe and effective" results. However, specific quantitative acceptance criteria and the numerical results against these criteria are not detailed in this document.
Sample Size (Test Set) & Data Provenance: Sample size is not explicitly stated. Data provenance is implied to be prospective mechanical testing, likely conducted in association with the Taiwanese manufacturer.
Experts for Ground Truth & Qualifications: Not applicable (physical device, not diagnostic AI).
Adjudication Method: Not applicable.
MRMC Study: Not applicable.
Standalone Study: Not applicable.
Type of Ground Truth: Mechanical testing against established engineering/biomechanical standards.
Training Set Sample Size: Not applicable.
Training Set Ground Truth Establishment: Not applicable.

The document primarily focuses on establishing "substantial equivalence" of the new sizes of the U-Motion II Acetabular System to previously cleared versions and predicate devices based on identical intended use, materials, design rationale, and various mechanical performance tests. The detailed data and specific acceptance thresholds for these tests would typically be found in the full 510(k) submission, not necessarily summarized in this high-level FDA letter or 510(k) summary.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 5, 2023

United Orthopedic Corporation Lois Ho Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu, 30075 Taiwan

Re: K221149

Trade/Device Name: U-Motion II Acetabular System-Extension line Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO Dated: December 7, 2022 Received: December 7, 2022

Dear Lois 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Limin Sun -S

Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K221149

Device Name

U-Motion II Acetabular System-Extension line

Indications for Use (Describe)

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

Painful, disabling joint disease of the hip resulting from: degenerative 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 techniques are less likely to achieve satisfactory results.
Correction of functional deformity.
Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is unmanageable using other techniques.

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

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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O U-Motion II Acetabular System—Extension line

Traditional 510 (k)

510(K) SUMMARY Traditional 510(k)

[as required by 21 CFR 807.92(c)]

Submitter information

Company Name:	United Orthopedic Corporation
Address	No 57, Park Ave 2, Science Park, Hsinchu City 30075, Taiwan
Telephone	+886-3-5773351 ext. 2220
Fax	+886-3-577156

Contact Person	Lois Ho, Regulatory Affairs Manager
Email address	lois.ho@unitedorthopedic.com
Date of submission	April 18, 2022

Trade Name, Common Name, Classification

Device Common Name:	Acetabular Component
Trade name:	U-Motion II Acetabular System—Extension line
Submitter Establishment Number:	9681642
Classification Regulation Number:	21CFR 888.3353
Classification Panel:	Orthopedic
Product Code:	LZO
Device Class:	Class II
Classification name:	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

Predicate devices

Product name	Manufacturer	510(k) Number
Primary Predicate
U-Motion II Acetabular System	United Orthopedic Corporation	K122185
Additional Predicates
U-Motion II PS+ Cup		K132455
U-Motion II Acetabular System—Additional sizes		K170089
E-XPE Acetabular Components and U-Motion II Acetabular Cup	United Orthopedic Corporation	K172833
U2 Hip System		K111546
Osteonics® HA Generation II Acetabular Component System	Osteonics Corporation	K983382

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Device description	The subject device, U-Motion II Acetabular System—Extension line, is anextension in terms of additional size to the previously cleared U-Motion IIAcetabular System (K122185, K132455, K170089 and K172833). The subjectdevice includes two components: U-Motion II Cup and U-Motion II XPE Cupliner. The indication, design rationale, material, major manufacture process andsterilization method of these two components are identical to the cleared U-MotionII Cup (K122185, K132455, K170089, and K172833) and U-Motion II XPE CupLiner (K122185 and K170089), except for the dimension.
	U-Motion II CupThe cleared U-Motion II Cup is available from 44 through 80 mm outer diameter(O.D.) in 2 mm increments. The subject U-Motion II Cup is available in 48 mmO.D. and 54 mm O.D. and the compatible liner diameter is 36 mm and 40 mm,respectively, which is larger than the cleared cups. It is designed to only becompatible with the subject cup liner.
	U-Motion II XPE Cup LinerThe cleared U-Motion II XPE Cup Liner is available in 28 mm, 32 mm, 36 mm,and 40 mm inner diameter (I.D.). The subject XPE Cup Liner is available in 36mm I.D. and 40 mm I.D., and is compatible with the subject 48 mm O.D. cup. and54 mm O.D. cup, respectively.
Indications for use	The device is used for reduction or relief of pain and/or improved hip function inskeletally mature patients with the following conditions:1. Painful, disabling joint disease of the hip resulting from: degenerativearthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascularnecrosis.2. Revision of previous unsuccessful femoral head replacement, cuparthroplasty or other procedure.3. Clinical management problems where arthrodesis or alternativereconstructive techniques are less likely to achieve satisfactory results.4. Correction of functional deformity.5. Treatment of nonunion femoral neck and trochanteric fracture of theproximal femur with head involvement that is unmanageable using othertechniques.This device is a single use implant and intended for cementless use only.
TechnologicalCharacteristics	The Subject device fundamental scientific principles and technologicalcharacteristics, including: the intended use, material and general design, are thesame as, or similar to, the primary predicate and the chosen additionalpredicate/reference devices.Summary of the technological characteristics: Intended use: identical Indications for Use, Anatomical sites, operating principles and conditions ofuse are identical No new risks associated to the Subject device compared to those of thepredicate devices. Verification activities on subject devices demonstrated equivalent safety andeffectiveness as compared to the predicate devices. Material: are identical to the primary predicate.
U-Motion II Acetabular System—Extension line		Traditional 510 (k)
✓ Geometry and size: thickness of the subject liner is the worst-case and hasbeen demonstrated equivalent safety and effectiveness as compared to thepredicate devices.✓ Sterilization: identical method as predicates.The technological characteristics of the Subject device are substantiallyequivalent to the predicate device(s).
Performance Analysis	Based on the modification items of the design rationale of the Subject device, thefollowing tests were conducted to evaluate the safety and effectiveness of thesubjected device, and the test results indicated that this device is safe and effective.Impingement analysis Range of motion Jumping distance analysis Wear simulation test Locking strength test Cup deformation test Cup fatigue test
Conclusion	Based upon equivalences in: intended use, patient population, site of application,conditions of use, operating principles, and the non-clinical performance data,the Subject device has been shown to be safe and effective and to performequivalently as compared to the legally marketed predicate devices.Therefore, the Subject devices are substantially equivalent to the legallymarketed predicate devices.

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Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.