(156 days)
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No
The document describes a mechanical implant (acetabular system) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for use in total hip arthroplasty to reduce or relieve pain and improve hip function in patients with various degenerative joint diseases and functional deformities. These actions are rehabilitative and therapeutic in nature.
No
Explanation: This document describes the "DYNASTY® Acetabular System," which is a total hip arthroplasty device, meaning it is an implant used for surgical replacement of the hip joint. Its stated purpose is to reduce pain and improve hip function in patients with various conditions, and it is a single-use device. It does not mention any function for diagnosing conditions, but rather for treating them.
No
The device description clearly outlines physical components made of Titanium alloy, UHMW Polyethylene, Cobalt Chrome alloy, and Alumina Ceramic, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the DYNASTY® Acetabular System is for total hip arthroplasty, which is a surgical procedure to replace a damaged hip joint. This is a therapeutic intervention performed in vivo (within the body).
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens.
- Device Description: The device description details the components of a hip implant (shells, liners, heads) which are surgically implanted into the patient.
The information provided clearly indicates this is a surgical implant, not a diagnostic device used with in vitro samples.
N/A
Intended Use / Indications for 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 acctabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- correction of functional deformity; and, 3.
- revision procedures where other treatments or devices have failed. 4.
The size 50 and 54mm ceramic femoral heads are only intended for patients with giganticism or malunion of the acetabulum, and/or revision.
The DYNASTY® Acctabular Shell is for both cemented and uncemented use and is a single use device.
Product codes (comma separated list FDA assigned to the subject device)
KWA, JDL
Device Description
The design features of the DYNASTY® Acctabular System are summarized below:
- Shells manufactured from Titanium alloy, coated with CP Titanium
- Shell sizes: 46mm-76mm outer diameter
- Liners manufactured from UHMW Polyethylene
- Polyethylene liner sizes: 28mm, 50mm, 54mm inner diameter
- Liners manufactured from Cobalt Chrome alloy .
- Cobalt Chrome liner sizes: 52mm, 56mm inner diameter .
- Heads manufactured from Alumina Ceramic
- Head sizes: 50mm, 54mm diameter
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hip
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
K082924 (pg 1/2)
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
MAR - 6 2009
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 DYNASTY® Acetabular System.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | September 30, 2008 |
| Contact Person: | Matt Paul |
| Regulatory Affairs Specialist II | |
| Proprietary Name: | DYNASTY® Acetabular System |
| Common Name: | Acetabular Shell |
| Acetabular Liner | |
| Femoral Head | |
| Classification Name and Reference: | 21 CFR 888.3330 Prosthesis, hip, semi-constrained |
| (metal uncemented acetabular component) - Class | |
| III | |
| Device Product Code and Panel Code: | Orthopedics/87/KWA, JDL |
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 acctabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- correction of functional deformity; and, 3.
- revision procedures where other treatments or devices have failed. 4.
The size 50 and 54mm ceramic femoral heads are only intended for patients with giganticism or malunion of the acetabulum, and/or revision.
The DYNASTY® Acctabular Shell is for both cemented and uncemented use and is a single use device.
1
K082924 (pg 2/2")
B. Device Description
The design features of the DYNASTY® Acctabular System are summarized below:
- Shells manufactured from Titanium alloy, coated with CP Titanium
- Shell sizes: 46mm-76mm outer diameter
- Liners manufactured from UHMW Polyethylene
- Polyethylene liner sizes: 28mm, 50mm, 54mm inner diameter �
- Liners manufactured from Cobalt Chrome alloy .
- Cobalt Chrome liner sizes: 52mm, 56mm inner diameter .
- Heads manufactured from Alumina Ceramic �
- Head sizes: 50mm, 54mm diameter
C. Substantial Equivalence Information
The indications for use of the DYNASTY® Acetabular System arc identical to the previously cleared predicate devices. The design features and matcrials 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, matcrials information, and analysis data provided within this Premarket Notification.
2
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 with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wright Medical Technology, Inc. % Mr. Matt Paul Sr. Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002
MAR - 6 2009
K082924 Re:
Trade/Device Name: DYNASTY® Acetabular System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, JDL Dated: February 4, 2009 Received: February 5, 2009
Dear Mr. Paul:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered print to May 20, 1977 y is accordance with the provisions of the Federal Food, Drug, devices that mave boon require approval of a premarket approval application (PMA). and Costinette Act (110.) that to nevice, subject to the general controls provisions of the Act. The 1 ou may, increrere, mains of the Act include requirements for annual registration, listing of general voltable provision 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 If your device is classified (600 a00 vols. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the overnments concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease oc advised that I Driv issuantes spour device complies with other requirements of the Act that I DA has made a actuations administered by other Federal agencies. You must of any I catal statutes and regaranents, including, but not limited to: registration and listing (21 Colliply with an the 110t STequirements, one 801); good manufacturing practice requirements as set CFN Fart 807), adomig (21 CFR Part 820), good if applicable, the electronic forul in the quality systems (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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark McMahon
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): KOB2924 (pos 1/1)
Device Name: DYNASTY® Acetabular System
Indications For 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, 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 size 50 and 54mm ceramic femoral heads are only intended for patients with giganticism or malunion of the acetabulum, and/or revision.
The DYNASTY® Acetabular Shell is for both cemented and uncemented use and is a single use device.
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)
Mark A. Millham
(Division Sign-Of Division of General, Restorative, and Neurological De
Page 1 of 1
510(k) Number