(338 days)
No
The summary describes a hip implant shell manufactured using additive manufacturing (3D printing). There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the material properties and mechanical performance of the physical implant.
Yes.
The device is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function, which clearly indicates a therapeutic purpose.
No
The device description clearly states its purpose as "intended for use in total hip arthroplasty," and the device itself is an "Acetabular Shell" used as an implant. These are therapeutic uses, not diagnostic.
No
The device description clearly states the device is a physical implant made from titanium alloy powder through an additive manufacturing process. It is a hardware device intended for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for total hip arthroplasty to reduce pain and improve hip function in skeletally mature patients. This is a surgical procedure involving implantation of a device, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as an acetabular shell made from titanium alloy, designed for cementless use. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The device is clearly an implantable medical device used in a surgical setting.
N/A
Intended Use / Indications for Use
The Prime and DYNASTY® Additive Manufacturing Shells are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use
-
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.
Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
OOG, OQI, LPH, LZO
Device Description
MicroPort Orthopedics Inc. is introducing the Prime and DYNASTY® Additive Manufacturing (AM) Shells as a line extension of its existing Prime and DYNASTY® Acetabular Systems. The Prime and DYNASTY® AM Shells are made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process and are designed for cementless use on the bone interfacing surface. The device design is identical to its corresponding predicate devices. The design features of the Prime and DYNASTY® AM Shells are summarized below.
- Prime AM Shells: ●
- Material of Shell and Porous Coating: Titanium Alloy (Ti-6A1-4V) AM powder -
- Available in the following configurations and their respective sizes: -
- Solid (46mm-68mm outer diameter)
- Quad (42mm- 68mm outer diameter) .
- Sterilization: Gamma Sterilization -
- DYNASTY® AM Shells: ●
- Material of Shell and Porous Coating: Titanium Alloy (Ti-6A1-4V) AM powder -
- Available in the following configurations and their respective sizes:
- o Standard (46mm- 76mm outer diameter)
- Primary (46mm-68mm outer diameter) o
- Revision (46mm-76mm outer diameter) o
- Sterilization: Gamma Sterilization -
The subject implants are single-use only, are provided sterile, and are prescription only devices, intended to be implanted only by orthopedic specialists in an operating room setting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip Joint
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Orthopedic specialists in an operating room setting.
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)
Non-clinical bench performance testing was conducted to evaluate and demonstrate the substantial equivalence of the subject Prime and DYNASTY® AM Shells to their legally marketed predicate and reference devices.
The testing and engineering analyses performed for the subject Prime and DYNASTY® AM Shells:
- The additively manufactured base material was evaluated for tensile strength, . fatigue properties, elemental analysis, and morphological analysis.
- . The subject BIOFOAM® coating was evaluated for tensile strength, elemental analysis, morphological analysis, shear strength, abrasion resistance, friction, and fatigue properties.
- . The additively manufactured final finished device was evaluated for deformation and frictional torque, electrochemical corrosion, and shell fatigue.
Predicate nonclinical test results were leveraged to support the subject devices via equivalency rationale.
- . MR Conditionality Assessments (Field Interactions, Artifacts, RF Heating)
- Push-out, Lever-out, Torque-out ●
A review of the testing data concludes that the subject devices are substantially equivalent to its identified legally marketed predicate and reference devices. Having met all acceptance criteria for mechanical testing performed on worst-case constructs, the subject Prime and DYNASTY® AM Shells do not introduce new or modified risks for safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
August 20, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Gillen Gonzales Regulatory Affairs Specialist I 5677 Airline Road Arlington, Tennessee 38002
Re: K202705
Trade/Device Name: Prime and DYNASTY® Additive Manufacturing Shells Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: OOG, OQI, LPH, LZO Dated: July 19, 2021 Received: July 20, 2021
Dear Gillen Gonzales:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Limin Sun, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K202705
Device Name
Prime and DYNASTY® Additive Manufacturing Shells
Indications for Use (Describe)
The Prime and DYNASTY® Additive Manufacturing Shells are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use
-
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.
Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) Summary
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 Prime and DYNASTY® Additive Manufacturing Shells.
| Submitted by: | MicroPort Orthopedics Inc.
5677 Airline Road, Arlington, TN 38002
Phone: 866-872-0211
Fax: 855-446-2247 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | September 15, 2020 |
| Contact Person: | Gillen Gonzales
Regulatory Affairs Specialist I |
| Proprietary Name: | Prime and DYNASTY® Additive Manufacturing
Shells |
| Common Name: | Uncemented Acetabular Shell |
| Classification Name and Reference: | 21 CFR 888.3358- Hip joint/metal/polymer/metal
semi-constrained porous-coated uncemented
prosthesis- Class II
21 CFR 888.3353- Hip joint
metal/ceramic/polymer semi-constrained cemented
or nonporous uncemented prosthesis - Class II |
| Subject Product Code and Panel Code: | Orthopedics/87/OQG, OQI, LPH, LZO |
| Primary Predicate: | Prime BIOFOAM® Acetabular Shells (K170444) |
| Additional Predicates: | DYNASTY® Acetabular System (K082924)
DYNASTY® BIOFOAM® Shell (K122382) |
| Reference Devices: | BIOFOAM® Additive Manufacturing (K170288) |
4
DEVICE INFORMATION
A. Device Description
MicroPort Orthopedics Inc. is introducing the Prime and DYNASTY® Additive Manufacturing (AM) Shells as a line extension of its existing Prime and DYNASTY® Acetabular Systems. The Prime and DYNASTY® AM Shells are made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process and are designed for cementless use on the bone interfacing surface. The device design is identical to its corresponding predicate devices. The design features of the Prime and DYNASTY® AM Shells are summarized below.
- Prime AM Shells: ●
- Material of Shell and Porous Coating: Titanium Alloy (Ti-6A1-4V) AM powder -
- Available in the following configurations and their respective sizes: -
- Solid (46mm-68mm outer diameter)
- Quad (42mm- 68mm outer diameter) .
- Sterilization: Gamma Sterilization -
- DYNASTY® AM Shells: ●
- Material of Shell and Porous Coating: Titanium Alloy (Ti-6A1-4V) AM powder -
- Available in the following configurations and their respective sizes:
- o Standard (46mm- 76mm outer diameter)
- Primary (46mm-68mm outer diameter) o
- Revision (46mm-76mm outer diameter) o
- Sterilization: Gamma Sterilization -
The subject implants are single-use only, are provided sterile, and are prescription only devices, intended to be implanted only by orthopedic specialists in an operating room setting.
B. Intended Use
The Prime and DYNASTY® Additive Manufacturing Shells are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use
-
- 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;
5
-
- Correction of functional deformity;
-
- Revision procedures where other treatments or devices have failed.
Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.
C. Substantial Equivalence Information
The design features and materials of the subject devices are substantially equivalent to those of the predicate/reference devices. The indications for use are identical to the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the subject devices are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
D. Nonclinical Testing
Non-clinical bench performance testing was conducted to evaluate and demonstrate the substantial equivalence of the subject Prime and DYNASTY® AM Shells to their legally marketed predicate and reference devices.
The testing and engineering analyses performed for the subject Prime and DYNASTY® AM Shells:
- The additively manufactured base material was evaluated for tensile strength, . fatigue properties, elemental analysis, and morphological analysis.
- . The subject BIOFOAM® coating was evaluated for tensile strength, elemental analysis, morphological analysis, shear strength, abrasion resistance, friction, and fatigue properties.
- . The additively manufactured final finished device was evaluated for deformation and frictional torque, electrochemical corrosion, and shell fatigue.
Predicate nonclinical test results were leveraged to support the subject devices via equivalency rationale.
- . MR Conditionality Assessments (Field Interactions, Artifacts, RF Heating)
- Push-out, Lever-out, Torque-out ●
A review of the testing data concludes that the subject devices are substantially equivalent to its identified legally marketed predicate and reference devices. Having met all acceptance criteria for mechanical testing performed on worst-case constructs, the subject Prime and DYNASTY® AM Shells do not introduce new or modified risks for safety and effectiveness.
6
E. Clinical Testing
Clinical data was not provided for the subject devices.
F. Sterilization Residuals
The subject Prime and DYNASTY® AM Shells were adopted into the current metal product gamma radiation sterilization family. The bacterial endotoxin test, also known as the Limulus amebocyte lysate (LAL) test, was performed using worst-case implants to verify that the subject implants meet the 20 endotoxin units (EU)/device pyrogen limit specification.
The existing testing was successfully performed and confirms that the worst-case implants for the metal product family meet the 20 EU/device limit for general implanted medical devices as outlined in ANSI/AAMI ST72 and USP .
G. Component and Accessory Compatibility
The Prime AM shells are compatible with all 510(k)-cleared Prime A-Class® and E-Class® liners while the DYNASTY® AM shells are compatible with all 510(k)-cleared DYNASTY® A-Class® liners. Both Prime and DYNASTY® AM shells are compatible with MicroPort Orthopedics' 510(k)-cleared cancellous bone screws. The Prime and DYNASTY® AM shells are used as a system with MicroPort Orthopedics' 510(k)-cleared heads, stems, and femoral necks.
H. Biocompatibility
Biocompatibility was evaluated per ISO 10993-1 and FDA Guidance Document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", published June 16, 2016. Raw material and processing/packaging materials were considered in this risk-based assessment. The subject devices were determined to be biocompatible and to not present undue risk to the patient.
The chemical composition of the raw material (Ti-6Al-4V) and the intended patient contact of the subject implants are identical to the predicate devices.
I. Conclusions
The indications for use and fundamental scientific technology of the subject devices are identical to the predicate devices. Design features, materials information, predicate testing and analysis data provided in this premarket notification adequately support the substantial equivalence of Prime and DYNASTY® AM Shells.