(139 days)
The DYNASTY™ Acetabular System is indicated for use in total hip arthroplasty 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 functional deformity; and,
- revision procedures where other treatments or devices have failed.
The DYNASTY™ Acetabular Shell is for both cemented and uncemented use.
The design features of the DYNASTY™ Ceramic Femoral Head and DYNASTY™ Neck Sleeve are summarized below:
- Heads manufactured from Alumina Ceramic .
- Head sizes: 28, 32, 36, 38, 40, 42, 46mm outer diameter .
- Neck sleeves manufactured from Titanium alloy .
- Neck sleeve sizes: short, medium, long, x-long .
The provided text is a 510(k) summary for the DYNASTY™ Acetabular System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance against specific acceptance criteria through a clinical study. Therefore, the requested information regarding acceptance criteria and a study to prove the device meets these criteria is not typically found in this document.
However, based on the information provided, here's what can be inferred or explicitly stated regarding the device's characteristics and the basis for its clearance:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the 510(k) summary. A 510(k) submission for this type of device typically relies on demonstrating equivalence to predicate devices in terms of design, materials, and intended use, rather than setting and meeting novel quantitative performance criteria through a specific study with reported performance metrics. The implicit "acceptance criteria" here would be achieving "substantial equivalence" to the predicate devices.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
No specific test set or associated sample size, data provenance, or study type is mentioned in this 510(k) summary. The submission focuses on comparing the new device's design and materials to existing cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not applicable and not provided. There wasn't a "test set" in the context of clinical performance that required expert adjudication for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and not provided.
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:
This is not applicable as the DYNASTY™ Acetabular System is a joint replacement device, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable, as the device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of a performance study for this device. The "ground truth" for a 510(k) in this context is the safety and effectiveness of the legally marketed predicate devices to which the new device is compared.
8. The sample size for the training set:
Not applicable. There is no mention of a training set as this is not an algorithm-based device.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what is provided regarding device acceptance (i.e., substantial equivalence):
- Implicit Acceptance Criterion: The device must be "substantially equivalent" to legally marketed predicate devices.
- Proof of Meeting Criterion: The submission argues for substantial equivalence based on:
- Identical Indications for Use: The DYNASTY™ Acetabular System has the "identical" indications for use as the previously cleared predicate devices.
- Similar Design Features: The ceramic femoral heads and titanium alloy neck sleeves have comparable design features (e.g., head sizes, neck sleeve sizes) to predicate devices.
- Similar Materials: The heads are manufactured from Alumina Ceramic, and neck sleeves from Titanium alloy, which are common and established materials for such devices, implying similarity to predicate device materials.
- Fundamental Scientific Technology: The submission states that "The fundamental scientific technology of the modified device has not changed relative to the predicate devices."
In essence, the "study" proving the device met "acceptance criteria" in this 510(k) context was a robust comparison by the manufacturer to existing, cleared devices, demonstrating that no new questions of safety or effectiveness were raised. The FDA's letter (K072656) confirms that they reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices, thereby allowing it to be marketed.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the use of the DYNASTYTM Acetabular System.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | January 4, 2008 |
| Contact Person: | Matt Paul |
| Regulatory Affairs Specialist II | |
| Proprietary Name: | DYNASTY™ Acetabular System |
| Common Name: | Femoral HeadNeck Sleeve |
| Classification Name and Reference: | 21 CFR 888.3353 Hip joint metal/ceramic/ polymersemi-constrained cemented or nonporousuncemented prosthesis - Class II |
| Device Product Code and Panel Code: | Orthopedics/87/LZO |
DEVICE INFORMATION
A. Intended Use
The DYNASTY™ Acetabular System is indicated for use in total hip arthroplasty 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, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
-
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed. 4.
The DYNASTYTM Acetabular Shell is for both cemented and uncemented use.
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072656
B. Device Description
The design features of the DYNASTY™ Ceramic Femoral Head and DYNASTY™ Neck Sleeve are summarized below:
- Heads manufactured from Alumina Ceramic .
- Head sizes: 28, 32, 36, 38, 40, 42, 46mm outer diameter .
- Neck sleeves manufactured from Titanium alloy .
- Neck sleeve sizes: short, medium, long, x-long .
C. Substantial Equivalence Information
The indications for use of the DYNASTY™ Acetabular System are identical to the previously cleared predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the DYNASTY™ Acetabular System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
FEB -6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wright Medical Technology, Inc. % Mr. Matt Paul Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
Re: K072656 Trade/Device Name: DYNASTY Acetabular System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: January 4, 2008 Received: January 7, 2008
Dear Mr. Paul:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. Matt Paul
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Barbara Buelind
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: DYNASTY™ Acetabular System
Indications For Use:
The DYNASTYTM Acetabular System is indicated for use in total hip arthroplasty 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 functional deformity; and,
-
- revision procedures where other treatments or devices have failed
The DYNASTY™ Acetabular Shell is for both cemented and uncemented use.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buellm
(Division Sign-Off Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K672656
1
§ 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.