(30 days)
The devise is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, 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; and
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.
The devise is intended for uncemented use and is single use only.
"UNITED" U2 Acetabular Cup - Plasma Spray is an extension of cleared "UNITED" U2 Acetabular Component (K050262). The materials, safety and effectiveness of this subject are identical to the previously cleared U2 Acetabular Cup (K050262), except for adding sizes and multi-hole cup design. The extension of each coating type is described as following:
- U2 Acetabular Cup Ti Plasma Spray Coating: This submitted device adds the clustered-hole and multi-hole designs in sizes 44 ~ 80 mm and extends the size of no-hole design to #80. The catalog numbers of the cleared no-hole design are shifted to be used by clustered-hole, and the no-hole design is given new catalog numbers and extends its size to # 80. They are coated with CP Ti powder (ASTM F1580) to form a rough surface.
- U2 Acetabular Cup -- HA/Ti plasma spray Coating: This submitted device extends cup size to #80 and increase the no-hole and multi-hole cup design for alternative. They are coated with dual coatings, which are CP Ti powder (ASTM F1580) for the inner layer and HA (ASTM F1185) for the outer layer.
This device is intended to be used with the previously cleared U2 Acetabular cup liner (K050262), U2 XPE liner (K111546), "UNITED" Femoral head (K994078, K022520), "United" Ceramic Femoral Head (K103497, K112463) and Titanium cancellous bone screw (K050262) in corresponding size. The modifications of Acetabular cup do not affect the intended use of the device or alter the fundamental scientific technology of the device.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "U2 Acetabular Cup, Plasma Spray" device:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical properties conform to FDA guidance: "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA" | The mechanical properties of the modified surface have been evaluated to conform to the specified FDA guidance. |
| Locking strength test demonstrates safety and effectiveness, and substantial equivalence to predicate devices. | The locking strength test was completed as part of the design assurance process and demonstrated that this device is safe and effective and is substantially equivalent to the predicate device. |
Study Information:
Please note that the provided 510(k) summary is for a medical device (hip prosthesis) and not an AI/software as a medical device (SaMD). Therefore, many of the requested points related to AI/SaMD studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details) are not applicable to this type of submission.
The "study" referenced in this document is primarily a mechanical performance study and demonstrating substantial equivalence to previously cleared predicate devices.
Non-Applicable / Not Provided for this Device Type:
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to mechanical testing, not a clinical data set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical properties is established through standardized testing methods, not expert clinical consensus.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. This is a hardware implant, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For mechanical tests, the "ground truth" is typically the established standard (e.g., ASTM standards) that the device must meet, measured by laboratory instruments.
- The sample size for the training set: Not applicable. There is no AI training set for this device.
- How the ground truth for the training set was established: Not applicable.
Summary of the "Study" and Justification:
The "study" or rather, the basis for clearance, relies on:
- Mechanical Performance Testing: The device underwent testing to ensure its mechanical properties conform to the FDA's "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis." This includes a "locking strength test."
- Substantial Equivalence: The primary strategy for regulatory clearance (510(k)) is to demonstrate that the new device is "substantially equivalent" to legally marketed predicate devices. The modifications introduced (additional sizes and multi-hole cup designs) were assessed and determined not to affect the intended use or fundamental scientific technology.
- Predicate Devices:
The "Performance Data" section explicitly states that the mechanical properties of the modified surface were "evaluated to conform" to the FDA guidance and that the "locking strength test demonstrated that this device is safe and effective and is substantially equivalent to the predicate device." This is the core of the evidence presented for this type of medical device submission.
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K 1217777
JUL 1 8 2012
ுப2 Acetabular Cup, Plasma Spray
510(k) Summary
510(k) Summary of Safety and Effectiveness
| Submitted by: | United Orthopedic Corporation |
|---|---|
| Address: | No 57, Park Ave 2, Science Park, Hsinchu 300, Taiwan |
| Phone Number: | +886-3-5773351 ext. 2212 |
| Fax Number: | +886-3-5777156 |
| Date of Summary: | June 15, 2012 |
| Contact Person | Fang-Yuan HoRegulation and Document Management |
| Proprietary Name: | U2 Acetabular Cup, Plasma Spray |
| Common Name: | Hip Prosthesis |
| Device Classification | Hip joint metal/polymer/metal semi-constrained porous-coated |
| Name and Reference: | uncemented prosthesis per 21CFR 888.3358This falls under the Orthopedics panel. |
| Device Class | Class II |
| Panel Code | Orthopaedics Device |
| Device Product Code: | LPH, MEH |
| Predicate Device: | 1. "United" U2 Acetabular Component (K050262)2. "ENCORE MEDICAL, L.P." FMP Acetabular Shell (K063257)3. "Depuy" Pinnacle® Duofix® HA Shells (K031495)4. "BIOMET®" Universal® Acetabular Component (K921301) |
Device Description:
"UNITED" U2 Acetabular Cup - Plasma Spray is an extension of cleared "UNITED" U2 Acetabular Component (K050262). The materials, safety and effectiveness of this
Page: Summary-1/3
ー…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
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subject are identical to the previously cleared U2 Acetabular Cup (K050262), except for adding sizes and multi-hole cup design. The extension of each coating type is described as following:
-
- U2 Acetabular Cup Ti Plasma Spray Coating: This submitted device adds the clustered-hole and multi-hole designs in sizes 44 ~ 80 mm and extends the size of no-hole design to #80. The catalog numbers of the cleared no-hole design are shifted to be used by clustered-hole, and the no-hole design is given new catalog numbers and extends its size to # 80. They are coated with CP Ti powder (ASTM F1580) to form a rough surface.
-
- U2 Acetabular Cup -- HA/Ti plasma spray Coating: This submitted device extends cup size to #80 and increase the no-hole and multi-hole cup design for alternative. They are coated with dual coatings, which are CP Ti powder (ASTM F1580) for the inner layer and HA (ASTM F1185) for the outer layer.
This device is intended to be used with the previously cleared U2 Acetabular cup liner (K050262), U2 XPE liner (K111546), "UNITED" Femoral head (K994078, K022520), "United" Ceramic Femoral Head (K103497, K112463) and Titanium cancellous bone screw (K050262) in corresponding size. The modifications of Acetabular cup do not affect the intended use of the device or alter the fundamental scientific technology of the device.
Intended Use
The devise is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
-
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- Inflammatory degenerative joint disease such as rheumatoid arthritis;
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OU2 Acetabular Cup, Plasma Spray
-
- Correction of function deformity;
-
- Revision procedures where other treatments or devices have failed; and
-
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.
The devise is intended for uncemented use and is single use only.
This is the same intended use as previously cleared for "UNITED" U2 Acetabular Component, K050262.
Basis for Substantial Equivalence:
The safety and effectiveness of this device are substantially equivalent to previously cleared U2 Acetabular Component (K050262), except for an extension in size distribution and for an increase of multi-hole cup design. The modifications do not change the intended use or fundamental scientific technology. In addition, the subject device is also substantial equivalence to the Predicate-"ENCORE MEDICAL, L.P." FMP Acetabular Shell (K063257), "Depuy" Pinnacle® Duofix® HA Shells (K031495) and "BIOMET" Universal® Acetabular Component (K921301).
Performance Data:
The mechanical properties of the modified surface have been evaluated to conform to FDA guidance: "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA". And the locking strength test completed as part of the design assurance process, demonstrated that this device is safe and effective and is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol with three overlapping, curved lines representing the eagle's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 18 2012
United Orthopedic Corporation % Ms. Fang-Yuan Ho Regulatory Affairs Manager No. 57 Park Ave 2 Science Park Hsinchu 300 Taiwan
Re: K121777
Trade/Device Name: U2 Acetabular Cup, Plasma Spray Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, MEH
Dated: June 15, 2012 Received: June 18, 2012
Dear Ms. 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. 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
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Page 2 -- Ms. Fang-Yuan Ho
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
erely yours,
.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation . Center for Devices and Radiological Health
Enclosure
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Indication for Use
K121777 510 (k) Number (if known):____________________________________________________________________________________________________________________________________________________
Device Name: Acetabular Cup, Plasma Spray
Indications for Use:
The devise is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- I. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, 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; and
-
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.
The devise is intended for uncemented use and is single use only.
Prescription Use x __ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign) |
|---|
| Division of Surgical, Orthopedic, |
| and Restorative Devices |
| 510(k) Number | K121777 |
|---|---|
| --------------- | --------- |
Page 1 of 1
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.