PROFEMUR® TL2 stems 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
Titanium plasma spray coatings applied to implant surfaces are intended for uncemented arthroplasty.

Device Description

The PROFEMUR® TL2 stems are monolithic wedge taper style stems manufactured from forged titanium alloy conforming to ASTM F620. The proximal portion (top third) of the TL2 stem possesses a titanium plasma spray coating, manufactured from pure titanium powder conforming to ASTM F1580. The stems will have a glass-beaded finish everywhere except for the trunnion and plasma spray coating region. The PROFEMUR® TL2 stems also have a vertical groove along most of the distal length of the stem to assist in rotational stability in the canal. The PROFEMUR® TL2 stems are designed for use in uncemented total hip arthroplasty. The PROFEMUR TL2 Stem is offered in 3 different neck variants, Standard (STD), High Offset (HO), and Ultra High Offset (UHO). The PROFEMUR TL2 Stems will be offered in sizes 0-12 for Standard (STD) and High Offset (HO), and 1-5, 11 & 12 in Ultra High Offset (UHO) with M/L Width ranging from 27-40mm and A/P width ranging from 13-17mm. All stem variants: standard, high offset, and ultra high offset 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). The PROFEMUR® TL2 stems are single use devices which will be provided sterile via Gamma Irradiation.

AI/ML Overview

This document (K191632) describes a 510(k) premarket notification for a hip joint prosthesis, the PROFEMUR® TL2 Stem System. The submission aims to demonstrate substantial equivalence to a predicate device already on the market.

Based on the provided text, the device in question is a medical implant (a hip stem), not a device that relies on algorithms or AI for diagnostic or assistive purposes. Therefore, many of the requested criteria related to "device performance" in terms of imaging analysis, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for training sets are not applicable.

The document focuses on the mechanical and material properties of the hip stem to prove its safety and effectiveness relative to a legally marketed predicate device.

Here's an analysis of the provided text against the requested criteria, highlighting where information is present and where it is not applicable:

1. A table of acceptance criteria and the reported device performance

The document details mechanical testing conducted to demonstrate substantial equivalence. The "acceptance criteria" are implied by successful completion of these tests, demonstrating equivalent performance to the predicate device and meeting relevant standards.

Acceptance Criteria (Implied by Standards and Comparison)	Reported Device Performance
Mechanical Performance:
Endurance properties/Fatigue (Femoral Components per ISO 7206-4)	"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"
Endurance properties/Fatigue (Neck Region per ISO 7206-6)	"The mechanical testing verifies that the subject PROFEMUR® TL2 Stems are substantially equivalent to the predicate PROFEMUR® TL Classic Hip Stems currently on the market and has met all mechanical testing requirements based on the worst case construct testing."
Overall Mechanical Requirements (per ASTM F2068, ISO 21535)
Finite Element Analysis (FEA) Verification (per ASTM-F2996)	"A. Finite Element Analysis, (FEA)" performed.
Biocompatibility/Non-Pyrogenicity:
Endotoxin Limit (20 EU/device)	"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 <161>, Medical Devices – Bacterial Endotoxin and Pyrogen Tests."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document mentions "worst case construct testing" for mechanical evaluation and "worst case implants" for endotoxin testing. It does not provide a specific numerical sample size (e.g., how many stems were tested for fatigue). This is typical for mechanical device testing where representativeness often comes from worst-case scenarios and defined samples per standard, rather than large statistical cohorts.
Data Provenance: The testing was conducted by MicroPort Orthopedics Inc., located in Memphis, Tennessee, USA. The document does not specify if external labs were used or the exact location where testing was performed, but it's presumed to be within the company's testing facilities or by contractors in the US. The data is prospective, in the sense that it was generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This device is a mechanical implant, not an AI/imaging device requiring expert interpretation for ground truth. Ground truth for mechanical devices is established through adherence to engineering standards and validated physical testing methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As above, no human expert adjudication is involved in the performance evaluation of a hip stem.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI-powered device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an AI-powered device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by:

Adherence to recognized international and national standards for orthopedic implants (e.g., ASTM, ISO standards listed within the document).
Comparative testing showing substantial equivalence to a legally marketed predicate device.
Successful completion of specified mechanical tests (Fatigue, FEA, ROM, etc.) and biocompatibility tests (Endotoxin).

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/machine learning model. The design and manufacturing processes are informed by established engineering principles and prior device experience.

9. How the ground truth for the training set was established

Not Applicable. As this is not an AI/machine learning model, there is no training set or associated ground truth establishment process in the context of machine learning. The "ground truth" for the device's design and manufacturing is based on established biomechanical and materials science principles, and regulatory requirements.

Summary

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October 7, 2019

Image /page/0/Picture/1 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

MicroPort Orthopedics Inc. Sneh Pingle Project Manager, Regulatory Affairs 5677 Airline Road Memphis, Tennessee 38002

Re: K191632

Trade/Device Name: PROFEMUR TL2 Stems 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: September 9, 2019 Received: September 10, 2019

Dear Sneh Pingle:

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

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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 mediation-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) K191632

Device Name PROFEMUR® TL2 Stem System

Indications for Use (Describe)

PROFEMUR® TL2 stems 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

Titanium plasma spray coatings applied to implant surfaces are intended 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)

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510(k) Summary

Submitted By:	MicroPort Orthopedics Inc.5677 Airline RoadArlington, TN 38002
	Telephone Number: (901) 290-5175
Date of Submission:	June 18, 2019
Contact Person:	Sneh PingleProject Manager, Regulatory AffairsTelephone number: (901) 867-4656Email: sneh.pingle@ortho.microport.com
Name of Device:	PROFEMUR® TL2 Stem
Common Name:	Femoral Hip Stem
Device Classification Name	21 CFR 888.3353- Hip joint metal/ceramic/polymer
And Reference:	semi-constrained cemented or nonporous uncementedprosthesis
Device Class:	Class II
Panel Code:	Orthopedics/87
Product Code:	LZO
Predicate Device:	PROFEMUR® TL CLASSIC HIP STEM (K123688, SE02/08/2013)This predicate has not been subject to a design-relatedrecall.

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Device Description:

Indications for Use:

PROFEMUR® TL2 stems 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

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
1. inflammatory degenerative joint disease such as rheumatoid arthritis;
1. correction of functional deformity; and,
1. revision procedures where other treatments or devices have failed

Titanium plasma spray coatings applied to implant surfaces are intended for uncemented arthroplasty.

Comparison of Technological Characteristics with the Predicate devices:

Device comparison described in this premarket notification demonstrate that the subject PROFEMUR® TL2 stems are substantially equivalent to the identified predicate PROFEMUR® TL Classic Hip Stems 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 in areas including design, intended use, material composition, operational principles and function.

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Discussion of the Non-clinical Testing/Performance Data:

Mechanical Testing:

MicroPort has evaluated the subject PROFEMUR® TL2 Stems to demonstrate substantial equivalence to the identified predicate PROFEMUR® TL Classic Hip Stems. Design verification testing for the subject implants was completed in accordance with

. ASTM-F2996 (2013): Standard Practice for Fine Element Analysis (FEA) of Non-Modular Metallic Orthopedic Hip Femoral Stems
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.
ASTM F2068 (2015): Standard Specification for Femoral Prostheses—Metallic . Implants.
ISO 21535 (2007): Non-active surgical implants -- Joint replacement implants --● Specific requirements for hip-joint replacement implants.

The testing performed for the subject PROFEMUR® TL2 Stems were:

A. Finite Element Analysis, (FEA),
B. Proximal Fatigue Evaluation,
C. Distal Fatigue Evaluation,
D. Range of Motion (ROM),

The mechanical testing verifies that the subject PROFEMUR® TL2 Stems are substantially equivalent to the predicate PROFEMUR® TL Classic Hip Stems currently on the market and has 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 implants to verify that the subject implants meet the 20 endotoxin units (EU)/device pyrogen limit specification. The subject PROFEMUR® TL2 Stems were adopted into the current worst case Hip Stem and Neck Endotoxin Family based on the product 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

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alternatives to batch testing and USP <161>, Medical Devices – Bacterial Endotoxin and Pyrogen Tests.

Conclusion:

Based on the design features, the use of established well-known materials, feature comparisons, indications for use, principle of operations and results of the mechanical testing, the subject PROFEMUR® TL2 Stem have shown to be substantially equivalent to the legally marketed predicate devices cited in this premarket notification.

Regulation Number and Section

§ 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.

Re: K191632

Indications for Use

Indications for Use (Describe)

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510(k) Summary

Device Description:

Indications for Use:

Indications for Use

Comparison of Technological Characteristics with the Predicate devices:

Discussion of the Non-clinical Testing/Performance Data:

Mechanical Testing:

Non-Pyrogenicity Endotoxin Testing:

Conclusion:

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

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