(85 days)
No
The document describes a mechanical implant (total hip system) and its materials. There is no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is indicated for pain relief and improved hip function in patients with specific conditions, which are therapeutic goals.
No.
This device, the MicroPort total hip system, is indicated for use in total hip arthroplasty to reduce or relieve pain and/or improve hip function. It is a prosthetic implant used for treatment, not for diagnosing conditions.
No
The device description explicitly states it is comprised of physical components (femoral heads, acetabular liners, and acetabular shells) made from materials like alumina matrix composite and titanium alloy. This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a total hip arthroplasty system, which is an implantable medical device used to replace a damaged hip joint. Its intended use is for surgical procedures to alleviate pain and improve hip function.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the MicroPort total hip system is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MicroPort 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.
Modular shells with porous metal bead coating may be used in either cemented or uncemented arthroplasty. Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.
The DYNASTY® Accabular System is intended for use in total hip arthroplasty for reduction or relief of pain and or immoved hip function in skeletally mature patients.
-
non-inflammatory degenerative joint disease such as osteoartinitis, avascular necrosis, ankylosis, protrusio acceabuli, and painful dysplasja:
-
inflammatory degenerative joint disease such as rheumatoid arthritis;
-
correction of functional deformity; and,
-
revision procedures where other treatments or devices have failed
Shells with BIOFOAM® metal four costing are intented arthroplasty. Modular shells with porcus metal bead coating may be used in either cemented or uncemented arthroplasty.
Product codes
LZO
Device Description
The DYNASTY® Acetabular System with Ceramic contains femoral heads in size 28mm manufactured from alumina matrix composite, mating acetabular liners manufactured from crosslinked polyethylene, and beaded acetabular shells manufactured from titanium alloy.
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 and tribologically. The mechanical testing on the subject and predicate devices was performed on wrought Cobalt Chrome modular neck spigots cleared under K091423 and K100866. The subject size 28mm ceramic head was used as a worst case in burst, post-fatigue burst, rotational stability, and pull off force testing. Wear testing compared the subject size 28mm femoral heads to the K130376 DYNASTY® Acetabular System. Range of motion evaluation compared the subject system to the predicate K052026 in three planes.
Clinical data was not provided for the subject devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K122382, K082924, K003016, K012091, K021346, K041114, K041586, K051995, K052915, K053588, K060358, K080663, K081090, K091423, K100866, K110399, K111698, K111699, K111910, K112080, K112150, K121221, K123434, K123688, K130984, K893685
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
| Submitted By: | MicroPort Orthopedics Inc.
5677 Airline Rd, Arlington TN, 38002
(866) 872-0211 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Date: | April 4, 2014 |
| Contact Person: | Matt Paul
Project Manager, Regulatory Affairs |
| Proprietary Name: | DYNASTY® Acetabular System with Ceramic |
| Common Name: | Acetabular Shell, Acetabular Liner, Femoral Head |
| Classification Name and Reference: | 888.3353 prosthesis, hip, semi-constrained,
metal/ceramic/polymer, cemented or non-porous,
uncemented Class II |
| Subject Product Code and Panel Code: | Orthopedics/87/LZO |
| Predicate Devices: | DYNASTY® Acetabular System with Ceramic
510(k): K130376
Shell: K002149; Liner: K052026; Head: K130376 |
DEVICE INFORMATION
A. Intended Use
MicroPort 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.
Modular shells with porous metal bead coating may be used in either cemented or uncemented arthroplasty. Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.
B. Device Description
The DYNASTY® Acetabular System with Ceramic contains femoral heads in size 28mm manufactured from alumina matrix composite, mating acetabular liners manufactured from crosslinked polyethylene, and beaded acetabular shells manufactured from titanium alloy.
1
K140043
C. Substantial Equivalence Information
The subject DYNASTY® Acetabular System with Ceramic is indicated to be paired with the following existing acetabular components summarized in Table 1. These shell types were cleared in K 130376 for use with larger diameter BIOLOX® DELTA ceramic-polyethylene bearings.
Table I. Compatible Shells, Including 510(k) Information. All shells were cleared for use with Biolox Delta heads and polyethylene liners in K130376.
| 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 |
The subject DYNASTY® Acetabular System with Ceramic is indicated to be paired with the following femoral components summarized in Table 2.
| Table 2. Compatible Femoral Components, Including 510(k) Information. All femoral stems were cleared for | |
|---|---|
| use with Biolox Delta heads in K130376, except K130984. |
| -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 |
| K112150 | PROFEMUR GLADIATOR HA HIP STEM |
| K121221 | PROFEMUR Z REVISION HIP STEM |
| K123434 | PROFEMUR Z CLASSIC STEM |
| K123688 | PROFEMUR TL CLASSIC STEM |
| K130984 | PROFEMUR RENAISSANCE CLASSIC STEM |
The design features of the subject femoral head devices are substantially equivalent to those of the predicate DYNASTY® Acetabular system devices cleared under K130376. The design features of the subject acetabular liner and shell devices are substantially equivalent to those of the predicate LINEAGE® Acetabular system devices cleared under K052026 and K002149. 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
Tab 008 - Page 2 of 3
2
K140043 DYNASTY® Acetabular System with Ceramic Traditional 510(k)
Tab: 510(k) Summary of Safety and Effectiveness
devices. Validation of sterilization residuals by ethylene oxide was conducted on devices cleared in K893685 and K002149; this validation was submitted in K130376, is applicable to the subject devices and is included again in this notification. 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.
D. Nonclinical Testing
The subject DYNASTY® Acetabular System with Ceramic was evaluated mechanically and The mechanical testing on the subject and predicate devices was performed on tribologically. wrought Cobalt Chrome modular neck spigots cleared under K091423 and K100866. The subject size 28mm ceramic head was used as a worst case in burst, post-fatigue burst, rotational stability, and pull off force testing. Wear testing compared the subject size 28mm femoral heads to the K130376 DYNASTY® Acetabular System. Range of motion evaluation compared the subject system to the predicate K052026 in three planes.
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 and K130376. 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
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 3, 2014
MicroPort Orthopedics, Inc. Max Mortensen, Ph.D. VP Global Quality Systems, Regulatory and Clinical Affairs, Reimbursement and Market Access 5677 Airline Road Arlington, Tennessee 38002
Re: K140043
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: Class II Product Code: LZO Dated: December 17, 2013 Received: January 8, 2014
Dear Dr. Mortensen:
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
4
Page 2 - Max Mortensen, Ph.D.
(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 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" (21 CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Lori A. Wiggins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
Indications for Use
510(k) Number (if known)
K140043
Device Name Dynasty Acetabular System
Indications for Use (Describe)
The DYNASTY® Accabular System is intended for use in total hip arthroplasty for reduction or relief of pain and or immoved hip function in skeletally mature patients.
-
non-inflammatory degenerative joint disease such as osteoartinitis, avascular necrosis, ankylosis, protrusio acceabuli, and painful hip dysplasja:
-
inflammatory degenerative joint disease such as rheumatoid arthritis;
-
correction of functional deformity; and,
-
revision procedures where other treatments or devices have failed
Shells with BIOFOAM® metal four costing are intented arthroplasty. Modular shells with porcus metal bead coating may be used in either cemented or uncemented arthroplasty.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
ices (30 )3 441
Please do not write below this line - continue on a separate page if needed.
CONSULTION CONTROLLER FOR FORIEDAUSE ONLY CONCELLER CONCELLERS CONCELLENT Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Elizabeth | @grank -S
Division of Orthopedic Devices
FORM FDA 3881 (9/13)