The SMS system is designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. Hip replacement is indicated in the following cases:

. Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia
· Avascular necrosis of the femoral head
· Acute traumatic fracture of the femoral head or neck
· Failure of previous hip surgery: joint reconstruction, internal fixation, arthroplasty, hip resurfacing replacement or total hip arthroplasty

Device Description

The SMS femoral stem is a cementless bone preserving short stem designed for proximal fixation in total or partial hip arthroplasty for primary or revision surgery.
The SMS implants are comprised of the following products:

SMS Cementless Solid Standard Stem (available in 15 sizes from size 1 to 15); and ●
SMS Cementless Solid Lateralized Stem (available in 15 sizes from size 1 to 15). .
Both are available on the US market via the clearance - K181693 and K201673.
SMS collared solid version, has been introduced as a product range extension to the stems currently marketed as the SMS product line (K181693 and K201673). Quadra P is the collared stem currently marked in US K192827.
The SMS implants are line extensions to Medacta's Total Hip Prosthesis - AMIStem-H, Quadra-S and Quadra-H Femoral Stems (K093944), AMIStem and Quadra - Line Extension (K121011), AMIStem-P, AMIStem-P Collared and AMIStem-H Proximal Coating Femoral Stems (K173794), Quadra-H and Quadra-R Femoral Stems (K082792), AMIStem-H Proximal Coating (K161635), MiniMAX (K170845), and SMS (K181693 and K201673).
The SMS implants are part of the Medacta Total Hip Prosthesis system. The Medacta Total Hip Prosthesis system consists of femoral stems, modular femoral heads and acetabular components. The acetabular components consist of metal cups and liners made of ultra-high molecular weight polyethylene (UHMWPE) or Highcross highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). Acetabular components include the Mpact DM (K143453), VersafitCup (K083116 and K092265), VersafitCup CC Trio (K103352), Mpact (K103721 and K132879), Mpact 3D Metal (K171966) and Medacta Bipolar Head (K091967).
The SMS stems can be combined with the CoCr ball heads (K072857, K080885 and K103721), Endo Head (K111145) or with the MectaCer BIOLOX® Forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the SMS Cementless Stem.

It's important to note that this document is a 510(k) summary for a medical device (hip implant), not an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria (such as effect size of human readers with AI assistance, standalone algorithm performance, ground truth for training set, training set size) are not applicable to this submission.

Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list "acceptance criteria" in a quantitative manner as one might find for an AI/ML device (e.g., target specificity/sensitivity). Instead, the criteria are implicitly derived from the performance tests conducted to demonstrate substantial equivalence to predicate devices. The device's performance is demonstrated through satisfying these tests.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance:
- Range of Motion (ROM) (per EN ISO 21535:2009)	Performance confirmed; testing leveraged from predicate device.
- Fatigue Testing (Stem Endurance) (per ISO 7206-4:2010 + A1:2016)	Performance confirmed; testing leveraged from predicate device.
- Fatigue Testing (Head and Neck Region Endurance) (per ISO 7206-6:2013)	Performance confirmed; testing leveraged from predicate device.
- Pull-off Force Testing (Taper Connections) (per ASTM F2009-00)	Performance confirmed; testing leveraged from predicate device.
Coating Performance:
- Hydroxyapatite properties (per ISO 13779-1:2008)	Performance confirmed; testing leveraged from predicate device.
- Tension Testing of Calcium Phosphate and Metal Coatings (per ASTM	Performance confirmed; testing leveraged from predicate device.
F1147-99)
Biocompatibility/Safety:
- Pyrogenicity (per European Pharmacopoeia §2.6.14 / USP <85> & <151>)	Bacterial Endotoxin Test (LAL) and Pyrogen test conducted. Device is not labeled as non-pyrogenic or pyrogen-free. Performance confirmed; testing leveraged from predicate device.
- Biocompatibility (general)	Performance confirmed; testing leveraged from predicate device.
Other Characteristics:
- CCD angle	Similar to predicate.
- Cementless application	Similar to predicate.
- Material of construction	Similar to predicate.
- Coatings and coating composition	Similar to predicate.
- Device usage, sterility, shelf life, packaging, sizes, stem lengths	Similar to predicate.
Substantial Equivalence:	The introduction of the SMS collared version does not create a new worst case; therefore, performance testing from the predicate device was leveraged. The SMS Collared implants are as safe and effective as the predicate devices (SMS solid stem, K181693 and K201673; and Quadra P collared, K192827).

Study Details:

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated in terms of number of devices. The "tests" here refer to mechanical and material property tests (e.g., fatigue testing, pull-off force, coating adherence). These tests are typically performed on a statistically relevant number of samples of the device and its components, but the exact count isn't in this summary.
Data Provenance: The data is derived from non-clinical studies (laboratory testing) and in comparison to predicate devices. There is no mention of human subject data, so concepts like "country of origin" or "retrospective/prospective" don't directly apply in the clinical sense. These are engineering specifications leveraged from previously cleared devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. For this type of device (hip implant), ground truth isn't established by human experts reviewing medical images or patient data in the typical sense of AI/ML device evaluation. The "ground truth" or standard for performance is established by recognized international and national standards (e.g., ISO, ASTM) for the mechanical and material properties of orthopedic implants.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human reviewers (experts) in establishing ground truth for diagnostic or prognostic studies, which is not the nature of the evaluation for this hip implant. The "adjudication" for mechanical tests would be adherence to the specified test methods and criteria outlined in the standards.

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

No MRMC study was done. This study concerns a physical orthopedic implant, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no "effect size of human readers improving with AI assistance."

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

Not applicable. This device is a physical hip implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance evaluation of this device is based on established engineering and material standards (ISO 21535, ISO 7206, ASTM F2009, ASTM F1147, ISO 13779, European Pharmacopoeia, USP). The device is deemed safe and effective and "substantially equivalent" if it meets the performance requirements stipulated by these standards, generally by demonstrating that it performs as well as, or better than, the predicate devices for which these criteria were previously established.

8. The sample size for the training set

Not applicable. This submission is for a physical medical device, not an AI/ML model that requires a training set. The "training" for this device would refer to the design and manufacturing process, which adheres to quality systems regulations.

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

Not applicable. As above, there is no "training set" in the context of an AI/ML algorithm. The design and manufacturing of the device follow established engineering principles and standards.

Summary

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December 2, 2020

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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118

Re: K203041

Trade/Device Name: SMS Cementless Stem 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, MEH, KWY, LZY Dated: November 18, 2020 Received: November 19, 2020

Dear Chris Lussier:

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

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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 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 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)

K203041

Device Name SMS Cementless Stem

Indications for Use (Describe)

The SMS system is designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. Hip replacement is indicated in the following cases:

. Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia
· Avascular necrosis of the femoral head
· Acute traumatic fracture of the femoral head or neck
· Failure of previous hip surgery: joint reconstruction, internal fixation, arthroplasty, hip resurfacing replacement or total hip 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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3.0 510(k) Summary

I. Submitter

Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66

Contact Person: Stefano Baj, Regulatory Affairs Director, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director of Quality and Regulatory, Medacta USA Date Prepared: October 6, 2020 Date Revised: October 22, 2020

II. Device

Device Proprietary Name:	SMS Cementless Stem
Common or Usual Name:	Femoral Stems
Classification Name:	Hip joint, metal/ceramic/polymer, semi-constrained, cemented or nonporous, uncemented prosthesis
Primary Product Code:	LZO, MEH, KWY, LZY
Regulation Number:	21 CFR 888.3353, 21 CFR 888.3390, 21 CFR 888.3360
Device Classification	II

III. Predicate Device

Primary predicate:

. SMS, K181693, K201673 Medacta International SA
The following device is referenced:
. Quadra P Collared, K192827, Medacta International SA.

IV. Device Description

The SMS femoral stem is a cementless bone preserving short stem designed for proximal fixation in total or partial hip arthroplasty for primary or revision surgery.

The SMS implants are comprised of the following products:

SMS Cementless Solid Standard Stem (available in 15 sizes from size 1 to 15); and ●
SMS Cementless Solid Lateralized Stem (available in 15 sizes from size 1 to 15). .

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Both are available on the US market via the clearance - K181693 and K201673.

SMS collared solid version, has been introduced as a product range extension to the stems currently marketed as the SMS product line (K181693 and K201673). Quadra P is the collared stem currently marked in US K192827.

The SMS implants are line extensions to Medacta's Total Hip Prosthesis - AMIStem-H, Quadra-S and Quadra-H Femoral Stems (K093944), AMIStem and Quadra - Line Extension (K121011), AMIStem-P, AMIStem-P Collared and AMIStem-H Proximal Coating Femoral Stems (K173794), Quadra-H and Quadra-R Femoral Stems (K082792), AMIStem-H Proximal Coating (K161635), MiniMAX (K170845), and SMS (K181693 and K201673).

The SMS implants are part of the Medacta Total Hip Prosthesis system. The Medacta Total Hip Prosthesis system consists of femoral stems, modular femoral heads and acetabular components. The acetabular components consist of metal cups and liners made of ultra-high molecular weight polyethylene (UHMWPE) or Highcross highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). Acetabular components include the Mpact DM (K143453), VersafitCup (K083116 and K092265), VersafitCup CC Trio (K103352), Mpact (K103721 and K132879), Mpact 3D Metal (K171966) and Medacta Bipolar Head (K091967).

The SMS stems can be combined with the CoCr ball heads (K072857, K080885 and K103721), Endo Head (K111145) or with the MectaCer BIOLOX® Forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).

V. Indications for Use

The SMS system is designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery.

Hip replacement is indicated in the following cases:

Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia
Avascular necrosis of the femoral head
Acute traumatic fracture of the femoral head or neck ●
Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip ● arthroplasty, hip resurfacing replacement or total hip arthroplasty.

VI. Comparison of Technological Characteristics

The SMS range extension implants and the predicate devices share the following characteristics:

CCD angle; ●
. cementless:
material of construction; ●
coatings and coatings composition; ●

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. biocompatibility:
device usage;
sterility; ●
shelf life; ●
packaging;
sizes:
stem lengths; .

SMS Collared is technologically different from the predicate devices as follows:

Medial Collar Shape and Dimensions
These differences do not introduce a new worst case from a clinical point of view or with respect to the biomechanical performance of the implants.

Performance Data VII.

The introduction of the SMS collared version does not create a new worst case; therefore, the following performance testing from the predicate device was leveraged to support this submission:

Non-Clinical Studies:

Performance Tests .
- o range of motion (ROM): EN ISO 21535:2009 Non-Active Surgical Implants -Joint Replacement Implants - Specific Requirements for Hip-Joint Replacement Implants;
- o fatigue testing: ISO 7206-4 Third Edition 2010-06-15 Implants for Surgery -Partial and Total Hip Joint Prostheses - Part 4: Determination of Endurance Properties and Performance of Stemmed Femoral Components [Including AMENDMENT 1 (2016)];
- fatigue testing: ISO 7206-6 Second Edition 2013-11-15 Implants for Surgery o Partial and Total Hip Joint Prostheses - Part 6: Determination of Endurance Properties of Head and Neck Region of Stemmed Femoral Components;
- pull off force testing: ASTM F2009-00 (Reapproved 2011) Standard Test Method о for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses.
Coating Tests ●
- o ISO 13779-1 Second Edition 2008-10-01 Implants for Surgery Hydroxyapatite -Part 1: Ceramic Hydroxyapatite; and
- ASTM F1147-99 Standard Test Method for Tension Testing of Calcium Phosphate o and Metal Coatings.
Pyrogenicity ●
- Bacterial Endotoxin Test (LAL test) was conducted according to European о Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85>) and pyrogen test according to USP chapter <151> for pyrogenicity determination; and
- the subject devices are not labeled as non-pyrogenic or pyrogen free. o

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Clinical Studies:

• No clinical studies were conducted.

VIII. Conclusion

Based on the above information, the SMS Collared implants are substantially equivalent to the identified predicate devices. Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics, as well as performance evaluations. The SMS Collared implants are as safe and effective as the predicate devices, SMS solid stem, (K181693 and K201673) and Quadra P collared (K192827).

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.