(139 days)
No
The summary describes a physical implantable device (acetabular system) and its mechanical/tribological testing, with no mention of software, algorithms, image processing, or terms related to AI/ML.
Yes.
The device is indicated for total hip arthroplasty to reduce pain and improve hip function, which are therapeutic goals.
No
This device is a total hip system intended for replacement of a hip joint, not for diagnosing conditions.
No
The device description clearly states it is manufactured from alumina matrix composite and describes physical components (sizes ranging from 32mm to 40mm), indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total hip arthroplasty. This is a procedure performed in vivo (within the body) to replace a damaged hip joint.
- Device Description: The device is described as an acetabular system (part of a hip implant) made from a specific material and offered in different sizes. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition. The device itself is the treatment.
IVD devices are used to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic device used to replace a joint.
N/A
Intended Use / Indications for Use
Wright Medical total hip systems are 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 degenerative joint disease such as rheumatoid arthritis; 2.
- correction of functional deformity; and, 3.
- revision procedures where other treatments or devices have failed 4.
Product codes (comma separated list FDA assigned to the subject device)
LZO
Device Description
The DYNASTY® Acetabular System with Ceramic is manufactured from alumina matrix composite. The components are offered in sizes ranging from 32mm to 40mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
skeletally mature patients
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)
The subject DYNASTY® Acetabular System with Ceramic was evaluated mechanically, tribologically, and chemically. Wear of the subject bearing was evaluated for comparison to a metalpoly bearing cleared under K052026. The mechanical testing on the subject and predicate devices was performed on wrought Cobalt Chrome modular neck spigots cleared under K091423 and K100866. The testing shows that it can be concluded that the subject ceramic material can be expected to perform well under normal physiological chemical and mechanical conditions.
Clinical data was not provided for the subject devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
K122382, K082924, K061547, K070785, K003016, K012091, K021346, K041114, K041586, K051995, K052915, K053588, K060358, K080663, K081090, K091423, K100866, K110399, K111698, K111699, K111910, K112080, K112150, K121221, K123434, K123688, K052026
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
§ 888.3353 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
JUL 0 3 2013
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 DYNASTY® Acetabular System with Ceramic.
(800) 238-7188
March 14, 2013
Yuan Li, Ph.D.
Femoral Head
uncemented
Wright Medical Technology, Inc.
Regulatory Affairs Specialist II
5677 Airline Rd, Arlington TN, 38002
DYNASTY® Acetabular System with Ceramic
888.3353 prosthesis, hip, semi-constrained, metal/ceramic/polymer. cemented or non-porous,
Class II
Submitted By:
Date:
Contact Person:
Proprietary Name:
Common Name:
Classification Name and Reference:
Subject Product Code and Panel Code:
Orthopedics/87/LZO
Predicate Devices:
DYNASTY® Acetabular System 510(k)s: K072656
DEVICE INFORMATION
A. Intended Use
Wright Medical total hip systems are 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, 3.
- revision procedures where other treatments or devices have failed 4.
B. Device Description
The DYNASTY® Acetabular System with Ceramic is manufactured from alumina matrix composite. The components are offered in sizes ranging from 32mm to 40mm.
C. Substantial Equivalence Information
The subject DYNASTY® Acetabular System with Ceramic is indicated to be paired with the following acetabular components, and 510(k) information is summarized in Table 1 and 2.
1
K070785; cleared for alumina-polyethylene under K072656
| Table 1. Compatible Shells, Including 510(k) Information | ||
|---|---|---|
| ---------------------------------------------------------- | -- | -- |
| 510(k) | Device Name |
|---|---|
| K122382 | DYNASTY® 10 Hole Revision Shells |
| K122382 | DYNASTY® BIOFOAM® 3-Hole Shells |
| K122382 | DYNASTY® BIOFOAM® Solid Shells |
| K122382 | DYNASTY® BIOFOAM® 5 Hole Shells |
| K082924 | DYNASTY® BIOFOAM® Shells |
| K061547; cleared for | |
| alumina-polyethylene- | |
| under K072656 | DYNASTY® Porous 3-Hole Shells, 50 to 58mm |
| K070785; cleared for | |
| alumina-polyethylene | |
| under K072656 | DYNASTY® Porous 3-Hole Shells, 60 to 68mm |
| Table 2. Compatible Liners, Including 510(k) Information | |
|---|---|
| 510(k) | Device Name |
| K061547; cleared for | |
| alumina-polyethylene | |
| under K072656 | DYNASTY® Standard A-CLASS® Poly Liners |
| K070785; cleared for | |
| alumina-polyethylene | |
| under K072656 | DYNASTY® 15° A-CLASS® Poly Liners |
| K070785; cleared for | |
| alumina-polyethylene | |
| under K072656 | DYNASTY® Standard A-CLASS® Revision Liners (Group E, F, G, H) |
The subject DYNASTY® Acetabular System with Ceramic is indicated to be paired with the following femoral components, and 510(k) information is summarized in Table 3.
DYNASTY® 15°A-CLASS® Revision Liners (Group E, F, G, H)
DYNASTY® Standard A-CLASS® Revision Liners (Group J, K)
DYNASTY® 15°A-CLASS® Revision Liners (Group J, K)
| 510(k) | Device Name |
|---|---|
| K003016 | PRO-FEMUR R |
| K012091 | PRO-FEMUR |
| K021346 | STEM HIP REPLACEMENT SYSTEM |
| K041114 | PROFEMUR TAPERED HIP STEM |
| K041586 | PROFEMUR S HIP STEM |
| K051995 | PROFEMUR RENAISSANCE HIP STEM |
| K052915 | PROFEMUR XTR HIP STEM |
| K053588 | PROFEMUR LX HIP STEM |
| K060358 | PROFEMUR TL HIP STEM |
| K080663 | PROFEMUR LX REVISION 5/8 COATED HIP STEM |
| K081090 | PROFEMUR LX 5/8 COATED HIP STEM |
| K091423 | PROFEMUR HIP SYSTEM MODULAR NECKS |
| K100866 | |
| K110399 | GLADIATOR PLASMA CLASSIC HIP STEM |
| K111698 | PROFEMUR(R) E CEMENTLESS HIP STEM |
| K111699 | PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM |
| K111910 | GLADIATOR HIP STEM |
| K112080 | PRESERVE HIP STEM |
Table 3. Compatible Femoral Components, Including 510(k) Information
2
DYNASTY® Acetabular System with Ceramic Traditional 510(k)
| K112150 | PROFEMUR GLADIATOR HA HIP STEM |
|---|---|
| K121221 | PROFEMUR Z REVISION HIP STEM |
| K123434 | PROFEMUR Z CLASSIC STEM |
| K123688 | PROFEMUR TL CLASSIC STEM |
The design features of the subject devices are substantially equivalent to those of the predicate DYNASTY® Acetabular system devices cleared under K072656. The indications of the subject device are identical to the predicate. Specific warnings are added in the package insert. The fundamental scientific technology of the modified devices has not changed relative to the predicate The safety and effectiveness of the DYNASTY® Acetabular System with Ceramic is devices. adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
D. Nonclinical Testing
The subject DYNASTY® Acetabular System with Ceramic was evaluated mechanically, tribologically, and chemically. Wear of the subject bearing was evaluated for comparison to a metalpoly bearing cleared under K052026. The mechanical testing on the subject and predicate devices was performed on wrought Cobalt Chrome modular neck spigots cleared under K091423 and The testing shows that it can be concluded that the subject ceramic material can be K100866. expected to perform well under normal physiological chemical and mechanical conditions.
E. Clinical Testing '
Clinical data was not provided for the subject devices.
F. Conclusion
The design features of the subject devices are substantially equivalent to the predicate devices. The instrument list and materials remain identical to those cleared under K122382. The safety and effectiveness of the DYNASTY® Acetabular System with Ceramic is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
3
Image /page/3/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three overlapping eagles.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 3, 2013
Wright Medical Technology, Incorporated % Mr. Dean Nachtrab Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002
Re: K130376
Trade/Device Name: DYNASTY® Acetabular System with Ceramic 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 Dated: May 29, 2013 Received: June 3, 2013
Dear Mr. Nachtrab:
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
4
Page 2 - Mr. Dean Nachtrab
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ReportalProblem/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.
Erin詞《èith
For
Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DYNASTY® Acetabular System with Ceramic Traditional 510(k) Tab: Indications for Use Statement
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K130376
Device Name: DYNASTY® Acetabular System with Ceramic
Indications for Use:
Wright Medical total hip systems are 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, 3.
-
- revision procedures where other treatments or devices have failed
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Eyaluation (ODE)