(171 days)
No
The device description and performance studies focus on the mechanical properties and material of the femoral heads, with no mention of AI or ML.
Yes
The device is a total hip arthroplasty system intended for the reduction or relief of pain and/or improved hip function in patients with various degenerative joint diseases and functional deformities, which are therapeutic goals.
No
Explanation: The device, MicroPort total hip systems and CoCr femoral heads, is an implant used in total hip arthroplasty for pain relief and improved hip function. It is a treatment device, not a diagnostic one as it does not diagnose a condition.
No
The device description clearly states it is a physical implant (femoral heads) made of cobalt chromium molybdenum alloy, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for total hip arthroplasty to address conditions like osteoarthritis, rheumatoid arthritis, and functional deformities. This is a surgical procedure involving the implantation of a medical device.
- Device Description: The device is described as a femoral head, a component of a total hip system. It is a physical implant designed to articulate within the hip joint.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is an in vivo (within the body) implant.
N/A
Intended Use / Indications for Use
MicroPort total hip systems are intended 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.
Product codes
LPH
Device Description
The subject MicroPort Orthopedics (MPO) CoCr femoral heads are spherical in shape and manufactured from low carbon cobalt chromium molybdenum alloy. The outer surface of the subject devices articulates against a polyethylene acetabular liner. The subject femoral heads possess an outer articulating surface finish of , Medical Devices - Bacterial Endotoxin and Pyrogen Tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K932222, K173898, K101575, K842559, K120599
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
July 15, 2019
Image /page/0/Picture/1 description: The image shows the logo for 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 includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
MicroPort Orthopedics Inc. Tejas Patel Senior Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002
Re: K190123
Trade/Device Name: MicroPort CoCr Femoral Heads 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: LPH Dated: June 17, 2019 Received: June 18, 2019
Dear Tejas Patel:
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 (OS) 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 Vesa Vuniqi 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
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Indications for Use
510(k) Number (if known) K190123
Device Name MicroPort CoCr Femoral Heads
Indications for Use (Describe)
MicroPort total hip systems are intended 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.
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)
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Image /page/3/Picture/1 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a rounded square icon on the left and the text "MicroPort" and "Orthopedics" on the right. The icon contains a four-pointed star inside of a circle.
MicroPort CoCr Heads Traditional 510(k) Tab 007: 510(k) summary
510(k) Summary
January 24, 2019
- MicroPort Orthopedics Inc. 1. Company: 5677 Airline Road Arlington, TN 38002 Telephone Number: (901) 290-5175
- ll. Contact: Tejas Patel Senior Regulatory Affairs Specialist Telephone number: (901) 290-5175 Email: tejas.patel@ortho.microport.com
- III. Trade Name: MicroPort CoCr Femoral Heads Classification: Class II Classification Name:
Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis (21 CFR 888.3358)
-
Subject Product Code and Panel Code:
Orthopedics/87/ LPH -
IV. Predicate Device:
- TRANSCEND® Articulation System (K170444, SE 06/26/2017)
This predicate has not been subject to a design-related recall.
V. Reference Device:
- SLT Femoral Head (K932222, SE 05/27/1994) .
- MicroPort Orthopedics Total Hip Systems MR Labeling (K173898, SE 09/20/2018)
- APEX Modular Head (K101575, SE 06/30/2010) ●
- Whiteside Ortholoc Total Hip Femoral (K842559, SE 12/20/1984) ●
- . Depuy M-Spec 36mm Femoral Heads (K120599, SE 04/30/2013)
VI. Device Description:
The subject MicroPort Orthopedics (MPO) CoCr femoral heads are spherical in shape and manufactured from low carbon cobalt chromium molybdenum alloy. The outer surface of the subject devices articulates against a polyethylene acetabular liner. The subject femoral heads possess an outer articulating surface finish of ≤3μin. The subject femoral heads are provided sterile. The proposed MPO femoral heads fill a gap in the current CoCr head offering. MicroPort CoCr heads are currently offered with short (S), medium (M), long (L) and extra-long (XL) offset for 32mm and 36mm diameter heads. The proposed new product offering in extra short (XS) and extra - long (XXL) offset
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Image /page/4/Picture/1 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a rounded square icon on the left and the text "MicroPort" on the right. Below "MicroPort" is the word "Orthopedics" in a smaller font size. The icon features a four-pointed star inside a circle.
will bring the CoCr heads offering into alignment with the current market presence of 32mm and 36mm heads.
The sole purpose for this traditional 510(k) is to seek clearance for the additional offering (XS and XXL) of the CoCr femoral heads in 32mm and 36mm sizes.
VII. Indications for Use:
The 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, ankyloses, protrusio acetabuli, and painful hip dysplasia.
-
- Inflammatory degenerative joint disease such as rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Revision procedures where other treatments or devices have failed.
VIII. Comparison of Technological Characteristics with the Predicate devices:
As established in this submission, the subject MPO CoCr femoral heads are substantially equivalent to the identified predicate devices cleared by the FDA for commercial distribution in the United States. The subject devices were shown to be substantially equivalent and have equivalent technological characteristics to their predicate devices through comparison in areas including design, intended use, material composition, operational principles and function.
IX. Discussion of the Non-clinical Testing/Performance Data:
Mechanical Testing:
MicroPort has evaluated the subject devices to demonstrate substantial equivalence to the identified predicate devices. Design verification testing for the subject implants was completed in accordance with
- ASTM F1714 - 96(2018) - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices
- . ASTM F2003 - 02(2015) Standard practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
- ASTM F1877-16, Standard Practice for Characterization of Particles, ASTM International, West Conshohocken, PA, 2016
- . ISO 14242-2 (2016): Implants for surgery -- Wear of total hip-joint prostheses --Part 2: Methods of measurement.
- . ISO 14242-3 (2009): Implants for surgery -- Wear of total hip-joint prostheses --Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test.
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Image /page/5/Picture/1 description: The image shows the logo for MicroPort Orthopedics. The logo consists of a square icon with rounded corners on the left, containing a stylized star shape inside a circle. To the right of the icon is the text "MicroPort" in a larger, bolder font, with the word "Orthopedics" underneath in a smaller font. The overall design is clean and professional.
MicroPort CoCr Heads Traditional 510(k) Tab 007: 510(k) summary
The tests completed were:
- Wear Testing
- Frictional Torque Test ●
The mechanical testing verifies that the subject components are substantially equivalent to the predicate devices currently on the market and have met all mechanical testing requirements based on the worst case construct testing.
Non-Pyrogenicity Endotoxin Testing:
The bacterial endotoxin test, also known as Limulus amebocyte lysate (LAL) test, was performed utilizing worst case subject implants to verify that the subject implants meet the 20 endotoxin units (EU)/device pyrogen limit specification. Testing was successfully performed and it was confirmed that the subject implants meet the 20 EU/device testing limit for general medical devices that are implanted as outlined in ANSI/AAMI ST72, Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing and USP , Medical Devices - Bacterial Endotoxin and Pyrogen Tests.
X. Component and Accessory Compatibility:
Table #1 and #2 show the compatibility of the subject devices with previously cleared MicroPort Orthopedics products.
| 510(k) | Device Name |
|---|---|
| K061547 | DYNASTY® Beaded Shells and Liners |
| K062693 | GLADIATOR™ Bipolar Shells and Liners |
| K070785 | DYNASTY® Beaded Shells and Liners |
| K082924 | DYNASTY® BIOFOAM® Shells and Liners |
| K122382 | DYNASTY® BIOFOAM® Shells and Liners |
| K142119 | PROCOTYL® L Beaded Shells and Liners |
| K170444 | PROCOTYL® PRIME Shell and Liners |
| K171181 | PROCOTYL® PRIME E-CLASS™ Shells and Liners |
| K180798 | Prime Acetabular Cup System |
| K181598 | Prime E-Class XLPE Liner |
Table #1: Compatible Shells and Liners, Including 510(k) information
Table #2: Compatible Femoral Components, Including 510(k) Information
| 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 |
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MicroPort CoCr Heads Traditional 510(k)
Tab 007: 510(k) summary
| 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 |
| K140676 | PROFEMUR TL CLASSIC LONG NECK HIP STEMS |
| K141235 | PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS |
| K150133 | PROFEMUR PRESERVE SIZE 1-3 HIP STEMS |
| K150302 | PROFEMUR PRESERVE CLASSIC STEM |
XI. Conclusion:
Based on the design features, the use of established well-known materials, feature comparisons, indications for use, and results of the mechanical testing, the subject MicroPort CoCr femoral heads have shown to be substantially equivalent to the legally marketed predicate devices cited in this summary.