(55 days)
This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
For use as a Total Hip Replacement
- 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.
For use as a Bipolar Hip Replacement
- Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Cemented stem is designed for cemented use only.
This device manufactured from CoCrMo alloy (ASTM F1537) is an extension of cleared "UNITED" U2 Acetabular Cup and Femoral Head (K022520) and "UNITED" U2 Hip System (K111546). The material, design, safety and effectiveness of this subject are identical to the previously cleared femoral heads except for its offset. The previously cleared femoral head offsets for the U2 Hip System are -3, +0, +5, and +10 mm. This submission adds +7.5 and +2.5 mm offset heads for 28, 32 and 36 mm diameter sizes. This device is intended to be used with the previously cleared U2 Acetabular Cup Liner (K050262), U2 XPE Liner (K111546), U2 bipolar implant (K101670), Revision Stem (K062978), HA/Ti Plasma Spray Stem (K003237), Ti Porous Coated Stem (K003237), UTF Stem (K110245), Press-fit Stem (K111546) and Cemented Stem (K111546) in corresponding size. The differences of femoral head offset do not affect the intended use of the device or alter the fundamental scientific technology of the device.
The provided text describes a Special 510(k) submission for "Femoral Heads, +2.5 and +7.5 mm Offset," which are extensions of previously cleared femoral head prostheses. This submission focuses on the addition of new offset sizes.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The device must be safe and effective and substantially equivalent to predicate devices. This is established by demonstrating that modifications (new offsets) do not change the indications or fundamental scientific technology, and that mechanical performance meets relevant guidance documents. Specifically, compliance with "Class II Special Controls Guidance Document- Hip Joint Metal Polymer Constrained Cemented or Uncemented Prosthesis" and "Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Components." | "Femoral Head Disassembly loads for the stems, completed as part of the design assurance process, demonstrated that this device is safe and effective and is substantially equivalent to the predicate device." The submission states the material, design, safety, and effectiveness are identical to previously cleared femoral heads except for the new offset sizes. |
2. Sample size used for the test set and the data provenance:
The document does not specify a distinct "test set" in the sense of a clinical or imaging dataset with a specific sample size. The evaluation for this device appears to be based on mechanical testing and design assurance processes, not human clinical data or imaging studies that would typically involve a "test set" of patients or scans.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The evaluation is based on mechanical testing and engineering principles, not expert interpretation of clinical data or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no mention of a test set requiring adjudication in the context of this device's evaluation.
5. 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 device is a mechanical implant (femoral head) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a mechanical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's acceptance stems from established engineering standards and regulatory guidance documents related to the safety and mechanical performance of hip implant components. Specifically, it relies on:
- Design Assurance Process Results: Demonstrating that the new offset configurations maintain the safety and effectiveness established for the predicate devices.
- Compliance with Guidance Documents: Adherence to "Class II Special Controls Guidance Document- Hip Joint Metal Polymer Constrained Cemented or Uncemented Prosthesis" and "Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Components."
- Mechanical Testing Results: "Femoral Head Disassembly loads for the stems" were explicitly mentioned as being completed as part of the design assurance process to show safety and effectiveness.
8. The sample size for the training set:
Not applicable. This device is a mechanical implant and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for this mechanical device, the concept of establishing ground truth for it does not apply.
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(0) Femoral Heads, +2.5 and +7.5 mm Offset: Special 510(k)
510(k) Summary of Safety and Effectiveness
OCT 1 0 2012
510(k) Summary
| 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: | +886-3-577156 |
| Date of Summary: | August 14, 2012 |
| Contact Person | Fang-Yuan HoRegulation and Document Management |
| Proprietary Name: | Femoral Heads, +2.5 and +7.5 mm Offset |
| Common Name: | Femoral Head 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 |
| Predicate Device: | 1. “UNITED” U2 Acetabular Cup and Femoral Head(K022520)2. “UNITED” U2 Hip System (K111546) |
Device Description:
This device manufactured from CoCrMo alloy (ASTM F1537) is an extension of cleared "UNITED" U2 Acetabular Cup and Femoral Head (K022520) and "UNITED" U2 Hip System (K111546). The material, design, safety and effectiveness of this subject are identical to the previously cleared femoral heads except for its offset. The previously cleared femoral head offsets for the U2 Hip System are -3, +0, +5, and +10 mm. This submission adds +7.5 and +2.5 mm offset heads for 28, 32 and 36 mm
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(0) Femoral Heads, +2.5 and +7.5 mm Offset: Special 510(k)
diameter sizes. This device is intended to be used with the previously cleared U2 Acetabular Cup Liner (K050262), U2 XPE Liner (K111546), U2 bipolar implant (K101670), Revision Stem (K062978), HA/Ti Plasma Spray Stem (K003237), Ti Porous Coated Stem (K003237), UTF Stem (K110245), Press-fit Stem (K111546) and Cemented Stem (K111546) in corresponding size. The differences of femoral head offset do not affect the intended use of the device or alter the fundamental scientific technology of the device.
Indications:
This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
For use as a Total Hip Replacement
-
- 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.
For use as a Bipolar Hip Replacement
-
- Femoral head/neck fractures or non-unions.
-
- Aseptic necrosis of the femoral head.
-
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Cemented stem is designed for cemented use only.
Basis for Substantial Equivalence:
The safety and effectiveness of the subject device are substantially equivalent to the
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(0) Femoral Heads, +2.5 and +7.5 mm Offset: Special 510(k) 510(k) Summary
ﺎﺯ ﺍﻟ
previously cleared "UNITED" Femoral Head (K022520, K111546), except for an increasing in the offset type. The modifications do not change the indications or fundamental scientific technology.
Performance Data:
This 510(k) submission was prepared in accordance with the Agency's, "Class II Special Controls Guidance Document- Hip Joint Metal Polymer Constrained Cemented or Uncemented Prosthesis" and "Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Components". Femoral Head Disassembly loads for the stems, 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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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
United Orthopedic Corp. % Ms. Fang-Yuan Ho. Regulation and Document Specialist No 57. Park Ave 2 Science Park, Hsinchu 300 Taiwan
OCT 10 2012
Re: K122504
Trade/Device Name: Femoral Heads, 2.5 and 7.5mm Neck Length Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated Regulatory Class: II Product Code: LPH Dated: August 14, 2012 Received: August 16, 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 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
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Page 2 – Ms. Fang-Yuan Ho
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 vours.
years,
For
O. Mallerwan
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
510 (k) Number (if known): K122504
Device Name: _Femoral Heads, +2.5 and +7.5 mm Offset
Indications for Use:
This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
For use as a Total Hip Replacement
-
- 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.
For use as a Bipolar Hip Replacement
-
- Femoral head/neck fractures or non-unions.
-
- Aseptic necrosis of the femoral head.
-
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Cemented stem is designed for cemented use only.
Over-The-Counter Use Prescription Use x AND/OR (21 CFR 801 Subpart C) ` (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
As Co
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page l of l
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122504
§ 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.