(114 days)
K112150 PROFEMUR® GLADIATOR® HA Hip Stem
No
The device description and performance studies focus on the mechanical properties, coating, and design of a hip stem implant. There is no mention of AI or ML technology.
Yes
The device is intended for use in total hip arthroplasty for the reduction or relief of pain and/or improved hip function, which aligns with the definition of a therapeutic purpose.
No
The device description clearly states it is a "femoral stem" and intended for use in "total hip arthroplasty," which is a surgical procedure to replace a joint, not to diagnose a condition.
No
The device description clearly details a physical implant (femoral stem) made of Ti6Al4V alloy with specific dimensions, coatings, and features for surgical implantation. It is a hardware device, 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 use in total hip arthroplasty for the reduction or relief of pain and/or improved hip function. This is a surgical procedure, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details a physical implant (femoral stem) made of metal, designed to be surgically placed in the body. This is characteristic of a medical device used for treatment or structural support, not for diagnosing a condition.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
- Performance Studies: The performance studies focus on mechanical testing, coating characterization, and non-pyrogenicity, which are relevant to the safety and efficacy of a surgical implant, not a diagnostic device.
In summary, the PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar is a surgical implant used for hip replacement, not a device used for in vitro diagnosis.
N/A
Intended Use / Indications for Use
PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
-
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
Hydroxyapatite coatings applied to implant surfaces are intended for uncemented arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
LZO, LPH
Device Description
The PROFEMUR® GLADIATOR® Thin Hydroxyapatite-coated (HA) Classic Stems with Collar present a monolithic, tapered-wedge design and a reduced distal stem tip. The 'Thin' description is a relative word MicroPort uses as an internal descriptor to clearly identify the difference in product between the currently cleared US-offered HA coating thickness (65um) and the coating thickness offered in outside US (OUS) markets. The subject stems are coated with a 65um HA coating (ASTM 1185), and the uncoated medial collar, proximal shoulder and neck regions of the stem possess a glass-beaded finish (Ra=0.8μm). The subject stems possess a proximal medial collar designed to assist in discouraging subsidence and maximizing rotational stability. The proximal anterior, posterior, and medial surfaces possess grooves perpendicular to the stem's longitudinal axis and parallel with each other. The proximal grooves are designed to provide a maximized bone-stem contact surface for bone apposition and assist in discouraging stem subsidence. The distal anterior and posterior surfaces of the subject stem possess vertical grooves parallel to the stem's longitudinal axis. The distal grooves are designed to assist the stem in resisting against rotational loads. The subject classic stems possess an oval impaction feature on the proximal shoulder for stem insertion into the femoral canal. The PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar are designed for use in total hip arthroplasty.
The PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar are manufactured from forged Ti6Al4V alloy (ASTM F620) and come in 10 sizes, with the stem length ranging from 125mm to 175mm. The subject stems features two different neck options: standard (with a CCD neck angle of 135°) and extended/Varus 8° (with a CCD angle of 127°). The PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar were designed to accommodate a wide range of patient anatomy and to provide an optimized fit to adequately restore the biomechanics of the respective hip (including restoration of the natural leg length and head center offset).
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 PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar were evaluated to demonstrate substantial equivalence to the identified predicate PROFEMUR® GLADIATOR® HA Hip Stem and reference PROFEMUR® GLADIATOR® Plasma Classic Hip Stem. Design verification testing for the subject devices was completed in accordance with:
- ISO 7206-4 (2010): Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components;
- ISO 7206-6 (2013) Implants for surgery Partial and total hip joint prostheses Part ● 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components;
- EN ISO 21535 (2009) Non-active surgical implants Joint replacement implants -● Specific requirements for hip-joint replacement implants.
- ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in Magnetic Resonance Environment
- ASTM F2119-07 Standard Test Method for Evaluation of MR Image Artifacts from ● Passive Implants
- ASTM F2182-11a Standard Test Method for Measurement of Radio Frequency ● Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging
- ASTM F2503-13 Standard Practice for marking Medical Devices and Other Items for ● Safety in the Magnetic Resonance Environment
The testing and analyses performed for the subject PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar were:
- Distal Fatigue Testing
- Proximal Fatigue Testing ●
- Range of Motion Analysis
- Magnetic Resonance Imaging Safety Analysis ●
- Coating Characterization of the Hydroxyapatite Coating
The mechanical testing and coating characterization verifies the subject PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar are substantially equivalent to the cleared predicate PROFEMUR® GLADIATOR® HA Hip Stem and cleared reference PROFEMUR® GLADIATOR® Plasma Classic Hip Stem currently on the market and has met all mechanical testing requirements based on the worst-case construct testing.
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.
K112150 PROFEMUR® GLADIATOR® HA Hip Stem
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.
K110399 PROFEMUR® GLADIATOR® Plasma Classic Hip Stem, K191632 PROFEMUR® TL2 Stems, K190123 MicroPort CoCr Femoral Heads
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
April 25, 2020
MicroPort Orthopedics Inc. Allen Mamaril Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
Re: K200007
Trade/Device Name: PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar 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, LPH Dated: December 30, 2019 Received: January 2, 2020
Dear Allen Mamaril:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,
Vesa Vuniqi, MS 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
510(k) Number (if known)
Device Name
PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar
Indications for Use (Describe)
PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
-
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
Hydroxyapatite coatings applied to implant surfaces are intended for uncemented arthroplasty.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image is a logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners on the left, inside of which is a white circle containing a red star-like shape. To the right of the square is the text "MicroPort" in a larger, bold blue font, with "Orthopedics" underneath in a smaller blue font. Below that is the text "Full Function, Faster" in a smaller, italicized blue font.
K200007 Page 1/4
510(k) Summary
In accordance with 21 CFR 807.92, this information serves as a summary of information upon which MicroPort Orthopedics claims substantial equivalence for the subject PROFEMUR® GLADIATOR® Thin HA Classic Stem with Collar.
| Submitted by: | MicroPort Orthopedics Inc.
5677 Airline Road,
Arlington, TN 38002
USA
Phone: (901) 290-5175 | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Date: | December 20, 2019 | |
| Contact Person: | Allen Mamaril
Regulatory Affairs Specialist II
Phone: (901) 867-4551 | |
| Proprietary Name: | PROFEMUR® GLADIATOR® Thin HA Classic
Stem with Collar | |
| Common Name: | Femoral Hip Stem | |
| Classification Name and
Reference: | 21 CFR 888.3353 – Hip joint metal/ceramic/ polymer
semi-constrained cemented or nonporous uncemented
prosthesis
21 CFR 888.3358 – Hip joint metal/polymer/metal
semi-constrained porous-coated uncemented
prosthesis | |
| Device Class: | Class II | |
| Panel Code: | Orthopedic/87 | |
| Product Code: | LZO, LPH | |
| Predicate Device: | K112150 PROFEMUR® GLADIATOR® HA Hip
Stem | |
| Reference Device: | K110399 PROFEMUR® GLADIATOR® Plasma
Classic Hip Stem
K191632 PROFEMUR® TL2 Stems
K190123 MicroPort CoCr Femoral Heads | |
4
Image /page/4/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue square with rounded corners, inside of which is a red star-like shape. To the right of the square is the text "MicroPort" in a larger, bold, blue font, with the word "Orthopedics" underneath it in a smaller, blue font. Below "Orthopedics" is the tagline "Full Function, Faster" in a smaller, blue, italicized font.
PROFEMUR® GLADIATOR® Thin HA Classic Stem w/ Collar Page 2/4 Traditional 510(k) Tab 007: 510(k) Summary
A. Device Description
The PROFEMUR® GLADIATOR® Thin Hydroxyapatite-coated (HA) Classic Stems with Collar present a monolithic, tapered-wedge design and a reduced distal stem tip. The 'Thin' description is a relative word MicroPort uses as an internal descriptor to clearly identify the difference in product between the currently cleared US-offered HA coating thickness (65um) and the coating thickness offered in outside US (OUS) markets. The subject stems are coated with a 65um HA coating (ASTM 1185), and the uncoated medial collar, proximal shoulder and neck regions of the stem possess a glass-beaded finish (Ra=0.8μm). The subject stems possess a proximal medial collar designed to assist in discouraging subsidence and maximizing rotational stability. The proximal anterior, posterior, and medial surfaces possess grooves perpendicular to the stem's longitudinal axis and parallel with each other. The proximal grooves are designed to provide a maximized bone-stem contact surface for bone apposition and assist in discouraging stem subsidence. The distal anterior and posterior surfaces of the subject stem possess vertical grooves parallel to the stem's longitudinal axis. The distal grooves are designed to assist the stem in resisting against rotational loads. The subject classic stems possess an oval impaction feature on the proximal shoulder for stem insertion into the femoral canal. The PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar are designed for use in total hip arthroplasty.
The PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar are manufactured from forged Ti6Al4V alloy (ASTM F620) and come in 10 sizes, with the stem length ranging from 125mm to 175mm. The subject stems features two different neck options: standard (with a CCD neck angle of 135°) and extended/Varus 8° (with a CCD angle of 127°). The PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar were designed to accommodate a wide range of patient anatomy and to provide an optimized fit to adequately restore the biomechanics of the respective hip (including restoration of the natural leg length and head center offset).
B. Intended Use
PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
-
- 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.
5
K200007 Page 3/4
Image /page/5/Picture/1 description: The image is a logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners on the left, inside of which is a white circle containing a red four-pointed star. To the right of the square is the text "MicroPort" in a bold, blue font, with "Orthopedics" in a smaller, lighter blue font underneath. Below that is the text "Full Function, Faster" in a smaller, lighter blue font.
-
- revision procedures where other treatments or devices have failed
Hydroxyapatite coatings applied to implant surfaces are intended for uncemented arthroplasty.
- revision procedures where other treatments or devices have failed
C. Substantial Equivalence Information
The design features and materials of the PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar are substantially equivalent to those of the predicate cleared under K112150. The indications of the subject devices are identical to the predicate. The fundamental scientific technology of the subject device has not changed relative to the predicate device. The safety and effectiveness of the subject devices are adequately supported by the substantial equivalence information, materials information, and analysis of data provided within this Premarket Notification.
D. Nonclinical Testing
The subject PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar were evaluated to demonstrate substantial equivalence to the identified predicate PROFEMUR® GLADIATOR® HA Hip Stem and reference PROFEMUR® GLADIATOR® Plasma Classic Hip Stem. Design verification testing for the subject devices was completed in accordance with:
- ISO 7206-4 (2010): Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components;
- ISO 7206-6 (2013) Implants for surgery Partial and total hip joint prostheses Part ● 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components;
- EN ISO 21535 (2009) Non-active surgical implants Joint replacement implants -● Specific requirements for hip-joint replacement implants.
- ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in Magnetic Resonance Environment
- ASTM F2119-07 Standard Test Method for Evaluation of MR Image Artifacts from ● Passive Implants
- ASTM F2182-11a Standard Test Method for Measurement of Radio Frequency ● Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging
- ASTM F2503-13 Standard Practice for marking Medical Devices and Other Items for ● Safety in the Magnetic Resonance Environment
6
Image /page/6/Picture/1 description: The image shows the logo for MicroPort Orthopedics. The logo consists of a blue square with a white circle inside, and a red star in the center of the circle. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in smaller blue text below it. Below that is the text "Full Function, Faster" in a smaller blue font.
The testing and analyses performed for the subject PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar were:
Page 4/4
- Distal Fatigue Testing
- Proximal Fatigue Testing ●
- Range of Motion Analysis
- Magnetic Resonance Imaging Safety Analysis ●
- Coating Characterization of the Hydroxyapatite Coating
The mechanical testing and coating characterization verifies the subject PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar are substantially equivalent to the cleared predicate PROFEMUR® GLADIATOR® HA Hip Stem and cleared reference PROFEMUR® GLADIATOR® Plasma Classic Hip Stem currently on the market and has met all mechanical testing requirements based on the worst-case construct testing.
E. Non-Pyrogenicity Endotoxin Testing
The bacterial endotoxin test, also known as Limulus amebocyte lysate (LAL) test, was performed utilizing worst case implants to verify that the subject implants meet the 20 endotoxin units (EU)/device pyrogen limit specification. The subject PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar were adopted into the current worst case Hip Stem and Neck Endotoxin Family based on the process operations. Testing was successfully performed and it was confirmed that the worst case 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.
F. 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 PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar have shown to be substantially equivalent to the legally marketed devices cited in this summary.