(214 days)
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, 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.
The device is intended for cementless use.
The subject device designed for total hip arthroplasty includes acetabular components and femoral components. The acetabular components are composed of a highly crosslinked ultra - high - molecular - weight - polyethylene articulating bearing surface fixed in a metal shell acetabular cup, while metal shell could be fixed with acetabulum by Ti Cancellous Screw and optional screw hole cover. The femoral component is composed of a ceramic femoral head.
U-Motion II Acetabular Cup includes U-Motion II HA Cup and U-Motion II PS Cup. It is manufactured from titanium alloy forging (ASTM F620) which are forged by titanium alloy bars conforming to ASTM F136. The outer surface of U-Motion II HA Cup is coated with dual coatings, CP Ti powder (ASTM F1580) for the inner layer and HA (ASTM F1185) for the outer layer. The materials of substrate and coating layers are identical to previous cleared "UNITED" U2 Acetabular Component (K050262, K12177). The outer surface of U-Motion II PS Cup is coated with CP Ti power. There are nineteen sizes of acetabular shell available, ranging from 44 through 80 mm outer diameter in 2 mm increments. U-Motion II Cup has a snap fit locking groove for acceptance of the U-Motion II XPE Cup Liner.
Clustered-hole and multi-hole series of U-Motion II Cup have shell holes for Ti Cancellous Screw fixation to the acetabulum. Ti Cancellous Screw are self tapping and in a 6.5 mm diameter with length of 15 to 60 mm in 5 mm increments. The designs of screw are identical with the cleared screws (K050262), except for the design of screw head. This subject device also has screws and hole covers available to cover the shell holes if desired. Screw and hole covers are manufactured from Ti-6Al-4V bar (ASTM F136).
U-Motion II XPE Cup Liner is manufactured from highly crosslinked UHMWPE which conforms to ASTM F2565 and the UHMWPE raw material is in accordance with ASTM F648 and ISO 5834. The materials are identical to previous cleared "UNITED" XPE liners of U2 Hip System (K111546). U-Motion II XPE Cup Liner includes 0° and 20° hood designs, which are available in 28 mm. 32 mm. 36 mm and 40 mm inside diameter (ID), The 28 mm inserts fit the acetabular shells with outer diameter (OD) ranging from 44-80 mm, the 32 mm inserts fit the acetabular shells ranging from 48-80 mm, the 36 mm inserts fit the acetabular shells ranging from 52-80 mm, and the 40 mm inserts fit the acetabular shells ranging from 56-80 mm.
40 mm Ceramic Femoral Head - Delta is an additional size extension to the previously cleared "UNITED" Ceramic Femoral Head--Delta (K103497, K112463). The materials, design, safety and effectiveness of this subject are identical to the previously cleared device (available in sizes 28 mm, 32 mm and 36 mm), except for its larger diameter. 40 mm Ceramic Femoral Head - Delta, developed by CeramTec AG, is made from an alumina matrix composite in accordance with ISO 6474-2 and is available in -3, +1, +5 and +9 mm of neck length.
U-Motion II Cup will be used with U-Motion II XPE Cup Liner, 40 mm Ceramic Femoral Head - Delta, previously cleared 28 mm, 32 mm metal Femoral Head (K022520, K111546) and Ceramic Femoral Head (K103479, K112463) in corresponding size. This device should not be used with those of another manufacturer's hip components since the articular and dimensional compatibility cannot be assured. The 40 mm Ceramic Femoral Head may be used with UTF Stem (K110245) and the stems made of titanium alloy in U2 Hip Stem series (K003237, K062978, K111546).
Here's a breakdown of the acceptance criteria and the study information for the U-Motion II Acetabular System, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The provided document describes a bench performance testing approach to demonstrate the device's safety and effectiveness. The acceptance criteria are implicitly met by showing that the device is "capable of withstanding expected in vivo loading without failure" and that "there are no new issues related to the safety and effectiveness" as confirmed by these tests. The device performance is deemed satisfactory if it passes these tests.
No explicit quantitative acceptance criteria (e.g., a specific threshold for shear strength, a maximum wear rate) are provided in this summary section, nor are specific reported performance values for each test type. Instead, the document states generally that a "review of the mechanical data indicates that the U-Motion II Acetabular System is capable of withstanding expected in vivo loading without failure."
| Acceptance Criteria (Implicitly Met by Passing) | Reported Device Performance |
|---|---|
| Mechanical strength and durability for modified surfaces (per ASTM F1854, F1160, F1044, F1147, F1978) | A review of the mechanical data indicates that the U-Motion II Acetabular System is capable of withstanding expected in vivo loading without failure. There are no new issues related to the safety and effectiveness of the subject devices based on these tests. (Specific quantitative results not provided in this summary). |
| Adequate locking strength of XPE Cup Liner (per ASTM F1820) | A review of the mechanical data indicates that the U-Motion II Acetabular System is capable of withstanding expected in vivo loading without failure. There are no new issues related to the safety and effectiveness of the subject devices based on these tests. (Specific quantitative results not provided in this summary). |
| Acceptable wear rate of XPE Cup Liner (per ISO 14242-1) | A review of the mechanical data indicates that the U-Motion II Acetabular System is capable of withstanding expected in vivo loading without failure. There are no new issues related to the safety and effectiveness of the subject devices based on these tests. (Specific quantitative results not provided in this summary). |
| Sufficient range of motion for XPE Cup Liner with femoral head (by CAD simulation) | A review of the mechanical data indicates that the U-Motion II Acetabular System is capable of withstanding expected in vivo loading without failure. There are no new issues related to the safety and effectiveness of the subject devices based on these tests. (Specific quantitative results not provided in this summary). |
| Durability and integrity of ceramic femoral head (burst, fatigue, rotational resistance, pull-off tests) | A review of the mechanical data indicates that the U-Motion II Acetabular System is capable of withstanding expected in vivo loading without failure. There are no new issues related to the safety and effectiveness of the subject devices based on these tests. (Specific quantitative results not provided in this summary). |
| Appropriate driving torque for Titanium Cancellous Bone Screw | A review of the mechanical data indicates that the U-Motion II Acetabular System is capable of withstanding expected in vivo loading without failure. There are no new issues related to the safety and effectiveness of the subject devices based on these tests. (Specific quantitative results not provided in this summary). |
| Material properties of XPE Cup Liner conform to standard (ASTM F2759) | A review of the mechanical data indicates that the U-Motion II Acetabular System is capable of withstanding expected in vivo loading without failure. There are no new issues related to the safety and effectiveness of the subject devices based on these tests. (Specific quantitative results not provided in this summary). |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical count of individual devices tested. The document refers to "the U-Motion II Acetabular System" and its components being evaluated against various ASTM and ISO standards for mechanical testing. These standards typically specify sample sizes for such tests.
- Data Provenance: The studies were bench tests (laboratory simulations), not clinical data from patients. The document does not specify the country of origin for the data; however, the manufacturer is in Taiwan.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of study. For bench testing of medical devices like an acetabular system, the "ground truth" is defined by established engineering and materials science standards (ASTM, ISO), and the performance is evaluated by engineers/technicians against these predefined criteria, not by medical experts establishing a diagnostic ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable as there was no expert adjudication process for this type of bench test. The results are based on objective measurements and adherence to specified test methods.
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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:
- This is not applicable. This submission is for a physical orthopedic implant (hip replacement components), not a diagnostic imaging AI device. Therefore, no MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable. This is a physical device, not an algorithm. However, the bench tests performed are akin to "standalone" performance evaluations in that they assess the device's inherent mechanical properties and durability without human interaction (beyond setting up and running the tests).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance relies on compliance with recognized international and national standards for medical device mechanical testing (ASTM F1854, F1160, F1044, F1147, F1978, F1820, F2759, ISO 14242-1, ISO 6474-2). These standards define the acceptable mechanical properties and testing methodologies for such implants. There is no biological or diagnostic "ground truth" in this context.
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The sample size for the training set:
- This is not applicable. This filing is for a physical medical device (orthopedic implant), not a machine learning or AI algorithm. Therefore, there is no "training set."
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How the ground truth for the training set was established:
- This is not applicable as there is no training set for a physical medical device.
§ 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.