Momentum Acetabular Cup System
Device Facts
| Record ID | K253948 |
|---|---|
| Device Name | Momentum Acetabular Cup System |
| Applicant | United Orthopedic Corporation |
| Product Code | LZO · Orthopedic |
| Decision Date | Sep 2, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3353 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Momentum Acetabular Cup System is intended for use in total hip arthroplasty in skeletally mature patients for the following conditions: 1. Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision of previously failed total hip arthroplasty. 6. Dislocation risks. The Momentum Acetabular Cup System implants are single use implants intended for cementless use only.
Device Story
Momentum Acetabular Cup System is a modular hip prosthesis for primary or revision total hip arthroplasty; used in cementless procedures. System components include acetabular shells, fixed liners (XPE or E-XPE), dual mobility metal liners, E-XPE mobile bearings, and screw hole covers. Device is implanted by orthopedic surgeons in clinical settings. Components interface with compatible femoral heads and stems to restore hip joint function. Benefits include improved joint mobility and stability for patients with degenerative or traumatic hip conditions. System provides fixed or dual mobility options to address specific patient anatomy and dislocation risk profiles.
Clinical Evidence
No clinical tests were performed. Safety and effectiveness were established through non-clinical bench testing, including Range of Motion (ISO 21535), Jumping Distance analysis, Articulating Surface Finish (ISO 7206-2), Impingement (ASTM F2582), Disassembly (ASTM F1820), Wear (ISO 14242-1), Deformation (ISO 7206-12), Shell Fatigue (ASTM F3090), Fretting Corrosion (ASTM F1875), Ti plasma spray coating characterization, and USP<161> bacterial endotoxin testing.
Technological Characteristics
Materials: Ti-6Al-4V (ASTM F136/ISO 5832-3) with CP Ti plasma spray (ASTM F1580); Co-Cr-Mo (ASTM F75); UHMWPE/XPE/E-XPE (ASTM F648, ASTM F2695, ISO 5834). Design: Cementless acetabular shell with optional screw holes, fixed or dual mobility liners. Sterilization: Identical to predicates. No software or electronic components.
Indications for Use
Indicated for skeletally mature patients undergoing total hip arthroplasty for non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity correction, non-union, femoral neck/trochanteric fractures, revision of failed arthroplasty, or dislocation risks.
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
- Trinity™ Dual Mobility System (K170359)
- G7 Dual Mobility System (K150522)
- Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings (K190656)
- G7 Acetabular System (K190660)
- G7 OsseoTi™ Acetabular Shells (K140669)
- G7™ Acetabular System (K121874)
- Trinity No Hole Acetabular Shells (K130128)
- U2 Acetabular System (K050262)
- Osteonics® HA Generation II Acetabular Component System (K983382)
- U-Motion II Acetabular System (K221149)
- EMPHASYS Acetabular System (K221636)
- OR3O Dual Mobility System (K220959)
Submission Summary (Full Text)
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**FDA U.S. FOOD & DRUG**
ADMINISTRATION
September 2, 2026
United Orthopedic Corporation
% Heather Neely
Head of Quality
UOC USA, Inc.
15251 Alton Pkwy., Suite 100
Irvine, California 92618
Re: K253948
Trade/Device Name: Momentum Acetabular Cup System
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, OQI, MEH, LPH
Dated: August 4, 2026
Received: August 4, 2026
Dear Heather Neely:
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K253948 - Heather Neely
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K253948 - Heather Neely
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assistance/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,
# RYAN TROMBETTA -S
For: 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: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K253948
Device Name
Momentum Acetabular Cup System
Indications for Use (Describe)
The Momentum Acetabular Cup System is intended for use in total hip arthroplasty in skeletally mature patients for the following conditions:
1. Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5. Revision of previously failed total hip arthroplasty.
6. Dislocation risks.
The Momentum Acetabular Cup System implants are single use implants intended for cementless use only.
Type of Use (Select one or both, as applicable)
☑
Prescription Use (Part 21 CFR 801 Subpart D)
☐
Over-The-Counter Use (21 CFR 801 Subpart C)
# CONTINUE ON A SEPARATE PAGE IF NEEDED.
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# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
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K253948 Page 1 of 4
Traditional 510(k)
Momentum Acetabular Cup System
UNITED
ORTHOPEDIC®
### 510(K) SUMMARY
### Traditional 510(k)
[as required by 21 CFR 807.92(c)]
Prepared by date: 2026-09-02
**Contact Details**
| Company Name | United Orthopedic Corporation |
| --- | --- |
| Company Address | No. 16, Luke 1st Rd. Luzhu Dist., Kaohsiung 82151 Taiwan |
| Company Contact Telephone | +88635773351 |
| Company Contact | Ms. Lois Ho |
| Company Contact Email | lois.ho@unitedorthopedic.com |
| Application Correspondent | Ms. Heather Neely |
| Application Correspondent Telephone | +1 949 328 3366 |
| Application Correspondent Email | heather.neely@unitedorthopedic.com |
**Device Name**
| Device Trade Name | Momentum Acetabular Cup System |
| --- | --- |
| Common Name | Total Hip Prosthesis |
| Classification Name | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis |
| Regulation Number | 888.3353 |
| Product Codes | LZO, OQI, MEH, LPH |
**Predicate Device Information** (Primary Predicate is listed first)
| 510(k) Number | Predicate Trade Name |
| --- | --- |
| K170359 | Trinity™ Dual Mobility System |
| K150522 | G7 Dual Mobility System |
| K190656 | Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings |
| K190660 | G7 Acetabular System |
| K140669 | G7 OsseoTi™ Acetabular Shells |
| K121874 | G7™ Acetabular System |
| K130128 | Trinity No Hole Acetabular Shells |
| K050262 | U2 Acetabular System |
| K983382 | Osteonics® HA Generation II Acetabular Component System |
| K221149 | U-Motion II Acetabular System |
| K221636 | EMPHASYS Acetabular System |
| K220959 | OR3O Dual Mobility System |
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K253948 Page 2 of 4
Traditional 510(k)
Momentum Acetabular Cup System
[LOGO]
UNITED
ORTHOPEDIC®
| **Device Description Summary** | Momentum Acetabular Cup System is designed for both primary and revision total hip arthroplasty. There are six components included in Momentum Acetabular Cup System for this 510(k), (1) Momentum Acetabular Shell, PS+, (2) Momentum XPE Liner, (3) Momentum E-XPE Liner, (4) Momentum Dual Mobility Metal Liner, (5) Momentum E-XPE Mobile Bearing, and (6) Momentum Set of Screw Hole Covers. This system includes Fixed type and Dual Mobility (DM) Mobile type. Momentum Acetabular Cup System is compatible with “United” Femoral Head (K022520, K103497, K111546, K112463, K122185, K122504, K152439, K162957, K221675) and Femoral Stem (K003237, K062978, K111546, K123550, K132207, K151316, K163193, K172251, K183312, K191056, K190100, K242249, K242315, K243466). (1) Momentum Acetabular Shell, PS+ Momentum Acetabular Shell, PS+ is manufactured from Ti-6Al-4V alloy, which complies with ASTM F136/ISO 5832-3. The outer surface of Momentum Acetabular Shell, PS+ is plasma spray coated with CP Ti powder (ASTM F1580). The thickness of CP Ti coating layer is 600±150 μm. There are 3 screw hole types available: No-Hole, Cluster-Hole, and Multi-Hole. The No-Hole type doesn’t provide the screw hole design. The Cluster-Hole type provides 3 screw holes. The Multi-Hole type provides 9-16 screw holes. The Cluster-Hole and Multi-Hole types can be used with the marketed Ti Cancellous Screw (K122185) and/or the subject device, Momentum Set of Screw Hole Covers. There are 15 sizes available for each screw hole type of Momentum Acetabular Shell, PS+. (2) Momentum XPE Liner Momentum XPE Liner is used with Momentum Acetabular Shell, PS+ and as a fixed type in Momentum Acetabular Cup System. It is manufactured from highly cross-linked UHMWPE (XPE), which complies with ASTM F648/ISO 5834-2 /ISO 5834-1. There are 2 types of edge features available: Neutral (0°) and Lipped (20°). There are 35 sizes available for Momentum XPE Liner. (3) Momentum E-XPE Liner Momentum E-XPE Liner is used with Momentum Acetabular Shell, PS+ and as a fixed type in Momentum Acetabular Cup System. It is manufactured from Vitamin E highly cross-linked UHMWPE (E-XPE), which complies with ASTM F648/ASTM F2695/ISO 5834-1. There are 4 types of edge features available: Neutral (0°), Lipped (20°), Face Changing, and Neutral +5mm. There are 35 sizes available for Momentum E-XPE Liner. (4) Momentum Dual Mobility Metal Liner Momentum Dual Mobility Metal Liner is used with Momentum Acetabular Shell, PS+ and Momentum E-XPE Mobile Bearing and as a DM mobile type in Momentum Acetabular Cup System. It is manufactured from Co-Cr-Mo alloy, which complies with ASTM F75. There are 10 sizes available for Momentum Dual Mobility Metal Liner. (5) Momentum E-XPE Mobile Bearing |
| --- | --- |
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K253948 Page 3 of 4
Traditional 510(k)
Momentum Acetabular Cup System
[LOGO]
UNITED
ORTHOPEDIC®
| | Momentum E-XPE Mobile Bearing is used with Momentum Dual Mobility Metal Liner and Momentum Acetabular Shell, PS+ and as a DM mobile type in Momentum Acetabular Cup System. It is manufactured from Vitamin E highly cross-linked UHMWPE (E-XPE), which complies with ASTM F648/ASTM F2695/ISO 5834-1. There are 17 sizes available for Momentum E-XPE Mobile Bearing. (6) Momentum Set of Screw Hole Covers Momentum Set of Screw Hole Covers are manufactured from UHMWPE, which complies with ASTM F648/ISO 5834-2/ISO 5834-1. These are available to cover the apical hole and the screw-hole of the Momentum Acetabular Shell, PS+ if the screw is not used. |
| --- | --- |
| **Intended Use/Indications for Use** | The Momentum Acetabular Cup System is intended for use in total hip arthroplasty in skeletally mature patients for the following conditions: 1. Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision of previously failed total hip arthroplasty. 6. Dislocation risks. The Momentum Acetabular Cup System implants are single use implants intended for cementless use only. |
| **Indications for Use Comparison** | The indications for use of the subject device are similar to the primary predicate device. |
| **Technological Comparison** | The Subject device fundamental scientific principles and technological characteristics, including: material and general design, are the same as, or similar to, the primary predicate and the chosen additional predicate/reference devices. Summary of the technological characteristics: - Applied anatomical sites, operating principles, and conditions of use are identical. - No new risks associated to the Subject device compared to those of the predicate devices. - Material: are identical or similar to the primary predicate. - Geometry and size: All of the sizes of the Subject device are bracketed in size by the predicates. - Sterilization: identical method as predicates. - The technological characteristics of the Subject device are similar to the predicate device(s). |
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K253948 Page 4 of 4
Traditional 510(k)
Momentum Acetabular Cup System
[Non-Text]
UNITED
ORTHOPEDIC®
| Non-Clinical and/or Clinical Tests Summary & Conclusions | Based on the design rationale of the Subject device, the following tests were conducted to evaluate the safety and effectiveness of the subjected device, and the test results indicated that this device is safe and effective.- Range of Motion (ROM) (ISO 21535)- Jumping Distance engineering analysis- Articulating Surface Finish (ISO 7206-2)- Impingement Test (ASTM F2582)- Disassembly Test (ASTM F1820)- Wear Test (ISO 14242-1)- Deformation Test (ISO 7206-12)- Shell Fatigue Test (ASTM F3090)- Fretting Corrosion Test (ASTM F1875)- Characterization of Ti Plasma Spray Coating- Usability Evaluation- Bacteria endotoxin testing was conducted and met the endotoxin limit as specified in USP<161>No clinical tests were performed to support the safety and effectiveness of the subject device.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 perform equivalently as compared to the legally marketed predicate devices.Therefore, the Subject device is substantially equivalent to the legally marketed predicate devices. |
| --- | --- |
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