(260 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the implant materials and design, with no mention of AI or ML.
Yes.
The device is described as a "Locking Cage" and "Full XPE Cup" for acetabular replacement, indicated for various degenerative joint diseases, which aligns with the definition of a therapeutic device designed to treat a medical condition or restore function.
No
The device description clearly states that these are "implants" designed for use in hip replacement surgeries, such as the "Locking Cage" for acetabular fixation and the "Full XPE Cup" for acetabular components. The intended use and device description focus on treating conditions through surgical implantation rather than diagnosing them.
No
The device description clearly outlines physical components made of materials like Ti6A14V and UHMWPE, which are implants for hip replacement. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The provided text describes a "United" Locking Cage and a "United" Full XPE Cup. These are implants designed to be surgically placed within the human body to replace or support damaged hip joints.
- Intended Use: The intended use clearly states that these devices are for surgical procedures related to hip replacement and revision. This is an in vivo (within the living body) application, not an in vitro application.
The device description and intended use are consistent with a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
For Locking Cage
- Revision of previous unsuccessful acetabular replacement.
- Class III segmental and/or cavitary acetabular defects which make it difficult to achieve satisfactory results while using standard total hip replacement acetabular components and procedures.
For Full XPE 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
LZO, JDI
Device Description
"United" Locking Cage
The "United" Locking Cage is designed to achieve stable and lasting fixation of the severely deficient acetabulum. The "United" Locking Cage includes locking cage and several accessory components including: ischial flange, hook, cancellous locking screw and auto break-off locking nut. They are all manufactured from Ti6A14V which confirms to ASTM F136-13.
"United" Full XPE Cup
The "United" Full XPE Cup is designed for cemented use and assembled with a PMMA Spacer and an X-ray marking wire. The Full XPE Cup is manufactured from highly cross-linked UHMWPE which conforms to ASTM F2565-06. The UHMWPE raw material is in accordance with ASTM F648-14 and ISO 5834-1:2005. The PMMA Spacer and X-ray marking wire are made of PMMA (Medical Grade) and Co-20Cr-15W-10Ni alloy (ASTM F90-14), respectively. The X-ray marking wire is designed for X-ray image identification purpose. The "United" Full XPE Cup is available in a range of sizes to fit varying anatomical requirements.
The "United" Locking Cage can be used with correspondent sizes of "United" Full XPE Cup with bone cement. The "United" Full XPE Cup is also compatible with "United" Metal Femoral Head (K994078, K022520, K111546 and K122504) and "United" Ceramic Femoral Head (K103497) in correspondent sizes. The "United" Femoral Heads can be used with various types of "United" hip stems (K003237, K062978, K111546, K123550, K132207, K151316 and K152530).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Acetabulum (hip)
Indicated Patient Age Range
Not Found
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. Structural compression stiffness of locking cage
- b. ROM for Full XPE Cup
- c. Bending fatigue testing of flanges
- d. Locking strength of locking cage and cemented cup
- e. Endurance testing
- f. 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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2017
United Orthopedic Corporation Ms. Gimpel Chien Regulation and Document Management No 57, Park Ave 2, Science Park Hsinchu 300 Taiwan
Re: K163441 Trade/Device Name: Locking Cage, Full XPE 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: LZO, JDI Dated: July 31, 2017 Received: August 2, 2017
Dear Ms. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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
510(k) Number (if known) K163441
Device Name Locking Cage, Full XPE Cup
Indications for Use (Describe)
For Locking Cage
-
Revision of previous unsuccessful acetabular replacement.
-
Class III segmental and/or cavitary acetabular defects which make it difficult to achieve satisfactory results while using standard total hip replacement acetabular components and procedures.
For Full XPE 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)
| ☒ 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."
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 | August 18, 2017 |
| Name of Device | |
| Trade Name | Locking Cage, Full XPE Cup |
| Common Name | Acetabular component |
| Regulation Name and | |
| Number | The device classification for Locking Cage, Full XPE Cup |
| are “prosthesis, hip, semi-constrained, metal/ceramic/polymer, | |
| cemented or non-porous, uncemented” and “prosthesis, hip, | |
| semi-constrained, metal/polymer, cemented” which are | |
| contained in the Code of Federal Regulation, under 21CFR | |
| 888.3353 and 21 CFR 888.3350, respectively. This falls | |
| under the Orthopedic Panel. | |
| Device Class | Class II |
| Classification Panel | Orthopaedics |
| Product Code | LZO, JDI |
| Predicate Device | 1. “Stryker Howmedica Osteonics” GAP-II Restoration |
| Acetabular Shells (K980774) |
- “Smith & Nephew” Cemented all polyethylene Acetabular
component (K991026) - “United” U-Motion II Acetabular Component (K122185) |
4
Locking Cage, Full XPE Cup
-
- "Howmedica" Trident® Crossfire® Polyethylene Liners (K021911)
Device Description:
"United" Locking Cage
The "United" Locking Cage is designed to achieve stable and lasting fixation of the severely deficient acetabulum. The "United" Locking Cage includes locking cage and several accessory components including: ischial flange, hook, cancellous locking screw and auto break-off locking nut. They are all manufactured from Ti6A14V which confirms to ASTM F136-13.
"United" Full XPE Cup
The "United" Full XPE Cup is designed for cemented use and assembled with a PMMA Spacer and an X-ray marking wire. The Full XPE Cup is manufactured from highly cross-linked UHMWPE which conforms to ASTM F2565-06. The UHMWPE raw material is in accordance with ASTM F648-14 and ISO 5834-1:2005. The PMMA Spacer and X-ray marking wire are made of PMMA (Medical Grade) and Co-20Cr-15W-10Ni alloy (ASTM F90-14), respectively. The X-ray marking wire is designed for X-ray image identification purpose. The "United" Full XPE Cup is available in a range of sizes to fit varying anatomical requirements.
The "United" Locking Cage can be used with correspondent sizes of "United" Full XPE Cup with bone cement. The "United" Full XPE Cup is also compatible with "United" Metal Femoral Head (K994078, K022520, K111546 and K122504) and "United" Ceramic Femoral Head (K103497) in correspondent sizes. The "United" Femoral Heads can be used with various types of "United" hip stems (K003237, K062978, K111546, K123550, K132207, K151316 and K152530).
5
Locking Cage, Full XPE Cup
Indications for Use:
For Locking Cage
Revision of previous unsuccessful acetabular replacement. 1.
Class III segmental and/or cavitary acetabular defects which make it difficult to 2. achieve satisfactory results while using standard total hip replacement acetabular components and procedures.
For Full XPE 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;
-
- 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.
Comparison to Predicate Device:
"United" Locking Cage
The "United" Locking Cage is substantially equivalent to "Stryker Howmedica Osteonics" GAP-II Restoration Acetabular Shells (K980774) in indications, design rationale, dimension characteristic and sterilization method.
"United" Full XPE Cup
The Full XPE Cup is substantially equivalent to "Smith & Nephew" REFLECTION cross-linked UHMWPE Acetabular Components (K991026) in indications, material, design rationale, dimension characteristic and sterilization method.
6
Performance Data:
● Non-clinical Performance
Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device:
- a. Structural compression stiffness of locking cage
- b. ROM for Full XPE Cup
- c. Bending fatigue testing of flanges
- d. Locking strength of locking cage and cemented cup
- e. Endurance testing
- f. 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.