U-Motion II Acetabular System-Extension line

K221149 · United Orthopedic Corporation · LZO · Jan 5, 2023 · Orthopedic

Device Facts

• Record ID: K221149
• Device Name: U-Motion II Acetabular System-Extension line
• Applicant: United Orthopedic Corporation
• Product Code: LZO · Orthopedic
• Decision Date: Jan 5, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. 2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. 3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. 4. Correction of functional deformity. 5. 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 Story

U-Motion II Acetabular System-Extension line is an expansion of existing acetabular cup and liner sizes. Device consists of metal acetabular cup and XPE (cross-linked polyethylene) liner; intended for cementless implantation in hip arthroplasty. Surgeon implants device to replace diseased or damaged hip joint surfaces. Provides mechanical support and articulation surface for femoral head. Benefits include pain relief and restoration of hip function. Device is single-use; implanted during orthopedic surgery.

Clinical Evidence

Bench testing only. Performance evaluation included impingement analysis, range of motion assessment, jumping distance analysis, wear simulation, locking strength testing, cup deformation testing, and cup fatigue testing. Results demonstrated that the subject device performs equivalently to the predicate devices.

Technological Characteristics

Acetabular cup and XPE liner system. Cementless fixation. Materials are identical to primary predicate. Dimensions: 48mm and 54mm outer diameter cups with 36mm and 40mm inner diameter liners. Sterilization method is identical to predicates.

Indications for Use

Indicated for skeletally mature patients requiring hip joint replacement due to degenerative, rheumatoid, or post-traumatic arthritis, late-stage avascular necrosis, revision of failed prior procedures, functional deformity, or nonunion femoral neck/trochanteric fractures.

Regulatory Classification

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.

Predicate Devices

• U-Motion II Acetabular System (K122185)
• U-Motion II PS+ Cup (K132455)
• U-Motion II Acetabular System—Additional sizes (K170089)
• E-XPE Acetabular Components and U-Motion II Acetabular Cup (K172833)
• U2 Hip System (K111546)
• Osteonics® HA Generation II Acetabular Component System (K983382)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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:

1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, post-traumatic arthritis or late stage avascular necrosis.

2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.

3. Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.

4. Correction of functional deformity.

5. 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)

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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 | [phone] ext. 2220 |
| Fax | [phone] |

| Contact Person | Lois Ho, Regulatory Affairs Manager |
|--------------------|-------------------------------------|
| Email address | [e-mail] |
| 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—<br>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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# © U-Motion II Acetabular System—Extension line

| Device description | The subject device, U-Motion II Acetabular System—Extension line, is an<br>extension in terms of additional size to the previously cleared U-Motion II<br>Acetabular System (K122185, K132455, K170089 and K172833). The subject<br>device includes two components: U-Motion II Cup and U-Motion II XPE Cup<br>liner. The indication, design rationale, material, major manufacture process and<br>sterilization method of these two components are identical to the cleared U-Motion<br>II Cup (K122185, K132455, K170089, and K172833) and U-Motion II XPE Cup<br>Liner (K122185 and K170089), except for the dimension. | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| | U-Motion II Cup<br>The cleared U-Motion II Cup is available from 44 through 80 mm outer diameter<br>(O.D.) in 2 mm increments. The subject U-Motion II Cup is available in 48 mm<br>O.D. and 54 mm O.D. and the compatible liner diameter is 36 mm and 40 mm,<br>respectively, which is larger than the cleared cups. It is designed to only be<br>compatible with the subject cup liner. | |
| | U-Motion II XPE Cup Liner<br>The cleared U-Motion II XPE Cup Liner is available in 28 mm, 32 mm, 36 mm,<br>and 40 mm inner diameter (I.D.). The subject XPE Cup Liner is available in 36<br>mm I.D. and 40 mm I.D., and is compatible with the subject 48 mm O.D. cup. and<br>54 mm O.D. cup, respectively. | |
| Indications for use | The device is used for reduction or relief of pain and/or improved hip function in<br>skeletally mature patients with the following conditions:<br>1. Painful, disabling joint disease of the hip resulting from: degenerative<br>arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular<br>necrosis.<br>2. Revision of previous unsuccessful femoral head replacement, cup<br>arthroplasty or other procedure.<br>3. Clinical management problems where arthrodesis or alternative<br>reconstructive techniques are less likely to achieve satisfactory results.<br>4. Correction of functional deformity.<br>5. Treatment of nonunion femoral neck and trochanteric fracture of the<br>proximal femur with head involvement that is unmanageable using other<br>techniques.<br>This device is a single use implant and intended for cementless use only. | |
| Technological<br>Characteristics | The Subject device fundamental scientific principles and technological<br>characteristics, including: the intended use, material and general design, are the<br>same as, or similar to, the primary predicate and the chosen additional<br>predicate/reference devices.<br>Summary of the technological characteristics: Intended use: identical Indications for Use, Anatomical sites, operating principles and conditions of<br>use are identical No new risks associated to the Subject device compared to those of the<br>predicate devices. Verification activities on subject devices demonstrated equivalent safety and<br>effectiveness 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 has<br>been demonstrated equivalent safety and effectiveness as compared to the<br>predicate devices.<br>✓ Sterilization: identical method as predicates.<br>The technological characteristics of the Subject device are substantially<br>equivalent to the predicate device(s). | | |
| Performance Analysis | Based on the modification items of the design rationale of the Subject device, the<br>following tests were conducted to evaluate the safety and effectiveness of the<br>subjected device, and the test results indicated that this device is safe and effective.<br>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,<br>conditions of use, operating principles, and the non-clinical performance data,<br>the Subject device has been shown to be safe and effective and to perform<br>equivalently as compared to the legally marketed predicate devices.<br>Therefore, the Subject devices are substantially equivalent to the legally<br>marketed predicate devices. | |

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