(266 days)
No
The device description and performance studies focus on the mechanical properties and design of hip replacement components, with no mention of AI or ML.
Yes
The device, an acetabular component for hip replacement, is intended for "reduction or relief of pain and/or improved hip function," which are therapeutic outcomes.
No
The device description clearly states it is an implant for hip replacement, designed to reduce pain and improve hip function by correcting deformity or treating painful joint diseases and fractures. The document also describes mechanical tests (locking strength, impingement, wear simulation, material properties) and mentions "X-ray marking wire" for "X-ray image identification purpose" which points to it being an intervention, not a diagnostic tool.
No
The device description clearly details physical components (cup liner, cemented cup, PMMA spacer, X-ray marking wire) and performance testing related to mechanical properties and wear, indicating it is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an implant for surgical procedures to treat hip joint conditions. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical components of an artificial hip joint (liners and cups) designed for implantation.
- Performance Studies: The performance studies focus on mechanical properties, wear simulation, and material properties relevant to an implantable device, not on the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to replace or augment a damaged hip joint.
N/A
Intended Use / Indications for Use
For E-XPE Cup Liner and U-Motion II Acetabular Cup
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 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 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.
For E-XPE Cemented Cup
-
Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, 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;
-
Treatment of nonunion and femoral neck fractures of the proximal femur with head involvement that is unmanageable using other techniques.
This device is a single use implant and intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
OQI, LZO, MEH, JDI, LWJ, KWY
Device Description
For E-XPE Acetabular Components
The subject E-XPE Acetabular Components includes U-Motion II E-XPE Cup Liner and E-XPE Cemented Cup. U-Motion II E-XPE Cup Liner includes 0° and 20° hood designs, which are available in 28 mm, 32 mm, 36 mm and 40 mm inner diameter (ID). The 28 mm liners fit the acetabular cups with outer diameter (OD) ranging from 44-46 mm, the 32 mm liners fit the acetabular cups ranging from 46-50 mm, the 36 mm liners fit the acetabular cups ranging from 50-70 mm, and the 40 mm liners fit the acetabular cups ranging from 56-70 mm.
The E-XPE Cemented Cup is design for cemented use and assembled with a PMMA Spacer and an X-ray marking wire. The cement mantle is built within the outer surface of acetabular cup. The PMMA Spacer is designed for cement fixation with a uniform cement thickness and the X-ray marking wire is designed for X-ray image identification purpose. E-XPE Cemented Cups are available in a range of sizes to fit varying anatomical requirements.
For U-Motion II Acetabular Cup
The indication for use, materials, cup hole types, size distribution, sterilization method, safety and effectiveness of subject device are identical to predicate device (K122185) except the locking design. The subject device are available in sizes from 44 mm through 80 mm outer diameter in 2 mm increments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance
Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device:
- a. Locking Strength Test
- b. Impingement Test
- c. Wear Simulation Test
- d. Abrasive Wear Simulation Test
- e. Range of Motion Analysis
- f. Material Properties of E-XPE Material
- g. Bacterial endotoxin testing was conducted and met the endotoxin limit as specified in USP .
Performance data demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.
Clinical Performance Data/Information
None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K122185, K111481, K130365, K163441, K050262, K111546
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 12, 2018 United Orthopedic Corporation Gimpel Chien Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu 300 Taiwan Re: K172833 Trade/Device Name: E-XPE Acetabular Components and U-Motion II Acetabular Cup 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: OQI, LZO, MEH, JDI, LWJ, KWY Dated: May 11, 2018 Received: May 14, 2018
Dear Gimpel Chien:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K172833
Device Name
I) E-XPE Acetabular Components II) U-Motion II Acetabular Cup
Indications for Use (Describe)
For E-XPE Cup Liner and U-Motion II Acetabular Cup
The device is used for reduction or relief of pain and/or improved hip function in sketally mature patients with the following conditions:
-
Painful, disabling joint disease of the hip 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 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.
For E-XPE Cemented Cup
-
Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, 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;
-
Treatment of nonunion and femoral neck fractures of the proximal femur with head involvement that is unmanageable using other techniques.
This device is a single use implant and intended for cemented use only.
Type of Use (Select one or both, as applicable)
X 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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3
510(k) Summary of Safety and Effectiveness
Submitter Information
| Name | United Orthopedic Corporation | |
|---|---|---|
| Address | No 57, Park Ave 2, Science Park, Hsinchu 300, Taiwan | |
| Phone Number | +886-3-5773351 ext. 2217 | |
| Fax Number | +886-3-577156 | |
| Name of Contact Person | Gimpel Chien | |
| Regulation and Document Management | ||
| Date prepared | September 13, 2017 | |
| Name of Device | ||
| Trade Name | I) | E-XPE Acetabular Components |
| II) | U-Motion II Acetabular Cup | |
| Common name | Acetabular Component | |
| Classification Name and | ||
| Regulation | I) | The device classification for E-XPE Acetabular |
| Components is “Hip joint metal/ceramic/polymer | ||
| semi-constrained cemented or nonporous uncemented | ||
| prosthesis” and “Hip joint metal/polymer | ||
| semi-constrained cemented prosthesis” which are | ||
| contained in the Code of Federal Regulation, under | ||
| 21CFR 888.3353 and 21CFR 888.3350. This falls under | ||
| the Orthopedic Panel. | ||
| II) | The device classification for U-Motion II Acetabular | |
| Cup is “Hip joint metal/ceramic/polymer | ||
| semi-constrained cemented or nonporous uncemented | ||
| prosthesis” which is contained in the Code of Federal | ||
| Regulation, under 21CFR 888.3353. This falls under the | ||
| Orthopedic Panel. |
4
| E-XPE Acetabular Components | 510(k) Summary | ||
|---|---|---|---|
| Device Class | Class II | ||
| Classification Panel | Orthopaedics | ||
| Product Code | I) E-XPE Acetabular Components: OQI, LZO, MEH, JDI | ||
| II) U-Motion II Cup: LZO, LWJ, KWY, MEH | |||
| Predicate Device | 1. “UNITED” U-Motion II Acetabular System (K122185) |
- “Corin” Trinity Acetabular System ECIMA Liners (K111481)
- “Encore” X-altTM Highly Cross Linked Acetabular Liner with Vitamin E (K130365)
- “UNITED” Locking Cage, Full XPE Cup (K163441)
- “UNITED” U2 Acetabular Component (K050262)
- “UNITED” U2 Hip System (K111546) | | |
| Reference Device | “UNITED” UCP Stem (K152530) | | |
Device Description:
For E-XPE Acetabular Components
The subject E-XPE Acetabular Components includes U-Motion II E-XPE Cup Liner and E-XPE Cemented Cup. U-Motion II E-XPE Cup Liner includes 0° and 20° hood designs, which are available in 28 mm, 32 mm, 36 mm and 40 mm inner diameter (ID). The 28 mm liners fit the acetabular cups with outer diameter (OD) ranging from 44-46 mm, the 32 mm liners fit the acetabular cups ranging from 46-50 mm, the 36 mm liners fit the acetabular cups ranging from 50-70 mm, and the 40 mm liners fit the acetabular cups ranging from 56-70 mm.
The E-XPE Cemented Cup is design for cemented use and assembled with a PMMA Spacer and an X-ray marking wire. The cement mantle is built within the outer surface of acetabular cup. The PMMA Spacer is designed for cement fixation with a uniform cement thickness and the X-ray marking wire is designed for X-ray image identification purpose. E-XPE Cemented Cups are available in a range of sizes to fit varying anatomical
5
C E-XPE Acetabular Components
requirements.
For U-Motion II Acetabular Cup
The indication for use, materials, cup hole types, size distribution, sterilization method, safety and effectiveness of subject device are identical to predicate device (K122185) except the locking design. The subject device are available in sizes from 44 mm through 80 mm outer diameter in 2 mm increments.
Intended Use:
For E-XPE Cup Liner and U-Motion II Acetabular Cup
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, 1. rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other 2. procedure.
- Clinical management problems where arthrodesis or alternative reconstructive 3. techniques are less likely to achieve satisfactory results.
- Correction of functional deformity. 4.
- Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur 5. with head involvement that is unmanageable using other techniques.
This device is a single use implant and intended for cementless use only.
For E-XPE Cemented Cup
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, and painful hip dysplasia;
-
- Inflammatory degenerative joint disease such as rheumatoid arthritis;
- Correction of function deformity; 3.
-
- Revision procedures where other treatments or devices have failed;
-
- Treatment of nonunion and femoral neck fractures of the proximal femur with head
6
C E-XPE Acetabular Components
involvement that is unmanageable using other techniques. This device is a single use implant and intended for cemented use only.
Comparison to Predicate Device:
For E-XPE Acetabular Components
The features of the subject devices are comparable to the predicate devices in terms of the same design, indication for use, locking mechanism and sterilization method expect material and size distribution. In material respect, the subject U-Motion II E-XPE Cup Liner is made from highly cross-linked Vitamin E UHMWPE (E-XPE) which is different from highly cross-linked UHMWPE (XPE) used for "UNITED" U-Motion II Acetabular System (K122185) but is substantially equivalent to "Corin" Trinity Acetabular System ECIMA Liners (K111481) and "Encore" X-alt™ Highly Cross Linked Acetabular Liner with Vitamin E (K130365). The subject E-XPE Cemented Cup is made from E-XPE, PMMA and Co-20Cr-15W-10Ni. These materials are identical with those used for "UNITED" Full XPE Cup (K163441) except E-XPE material. The size distribution of the subject devices is within the size range of "UNITED" U-Motion II Acetabular System (K122185) and "UNITED" Full XPE Cup (K163441). The differences between subject and predicate devices would not pose issues about safety and effectiveness. Non-clinical tests were also performed and the tests results demonstrate that the subject devices are substantially equivalent to the predicate devices.
For U-Motion II Acetabular Cup
The features of the subject devices are comparable to the predicate devices (K050262, K122185) in terms of the indication for use, materials, and sterilization method except the locking design and size distribution. The differences between the subject devices and predicate devices have been validated by locking strength testing to demonstrate that the subject U-Motion II Acetabular Cup does not introduce new risk of safety and effectiveness.
7
(9) E-XPE Acetabular Components
Performance Data:
● Non-clinical Performance
Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device:
- a. Locking Strength Test
- b. Impingement Test
- c. Wear Simulation Test
- d. Abrasive Wear Simulation Test
- Range of Motion Analysis e.
- Material Properties of E-XPE Material f.
- g. Bacterial endotoxin testing was conducted and met the endotoxin limit as specified in USP .
Performance data demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.
● Clinical Performance Data/Information
None provided as a basis for substantial equivalence.