The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo. The glenoid component is intended for cemented application. The humeral stems are intended for cemented or cementless use.

The Medacta Anatomic Shoulder Prosthesis – Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo. The glenoid component is intended for cemented application. The humeral short stem is intended for cementless use.

The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy failed joint replacement with a grossly deficient rotator cuff shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stems are intended for cemented or cementless use.

The Reverse Shoulder Prosthesis- Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral short stem is intended for cementless use.

Device Description

The Shoulder System - TiNbN Coating is a line extension to the Shoulder System to provide a larger product offering. The subject devices are marketed as individually packaged humeral head, Glenosphere and lateralized Glenosphere components.

Shoulder System - TiNbN Coating includes the following implants:

. Humeral Head TiNbN Coating (10 sizes, Ø 40 mm to Ø 58 mm)
. Lateralized Glenosphere TiNbN Coating implants (9 sizes) and
Glenosphere implants TiNbN Coating subject of this submission are comprised of the following products (9 sizes):
- Size Ø 32: to be coupled with Medacta Glenoid Baseplate Ø 22 or Ø 24.5mm o
- Size Ø 36: to be coupled with Medacta Glenoid Baseplate Ø 22 or Ø 24.5 or Ø27mm O
- Size Ø 39: to be coupled with Medacta Glenoid Baseplate Ø 24.5 or Ø27mm o
- Size Ø 42: to be coupled with Medacta Glenoid Baseplate Ø 24.5 or Ø27mm O

The Glenosphere and Lateralized Glenosphere - TiNbN Coating implants, are manufactured from CoCrMo ISO 5832-12 (Second Edition 2007-05-01) Implants For Surgery – Part 12: Wrought Cobalt- Chromium-Molybdenum Allov [Including: Technical Corrigendum 1 (2008)] with a TiNbN coating, while the Glenosphere screw packed with the implant is made of Ti alloy (Ti-6Al-4V), enhanced with Type-II anodization, according to ISO 5832-3:2016 Implants For Surgery -Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy.

The Humeral Head - TiNbN Coating implants, are manufactured from CoCrMo ISO 5832-12 (Second Edition 2007-05-01) Implants For Surgery - Part 12: Wrought Cobalt- Chromium-Molybdenum Alloy [Including: Technical Corrigendum 1 (2008)] with a TiNbN coating.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a medical device (Shoulder System - TiNbN Coating). It focuses on establishing substantial equivalence to existing predicate devices, primarily through non-clinical performance testing and comparison of characteristics, rather than clinical studies proving a specific performance metric against a ground truth.

Therefore, many of the requested elements for describing acceptance criteria and a study proving the device meets them (especially those related to clinical performance, expert ground truth, MRMC studies, and AI algorithms) are not applicable or cannot be extracted from this type of FDA submission.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not provide a table of quantitative acceptance criteria with corresponding reported numerical performance that would be typical for an AI/algorithm-based device study. Instead, it lists types of non-clinical tests performed, with the implied acceptance criterion being that the device met the requirements of the specified standards/protocols.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Meet requirements of defined test protocols for:	- Met requirements of Medacta Test Protocol IL 07.09.631 rev 0 and Medacta Test Report B.3 and ENDOLAB report 167 200908 60 238-rev 0 part 1 ASTM F2009-11: Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
Humeral Head TiNbN coated:	- Met requirements of Medacta Test Protocol IL07.09.630 rev 0 and Medacta Test Report B.1, and ENDOLAB report: 167 200908 60 238-rev 0 part 2 ISO 7206-4:2010(E) and ASTM F1378-17
- Pull-off testing (ASTM F2009-11)
- Fatigue testing (ISO 7206-4:2010(E), ASTM F1378-17)
Glenosphere TiNbN coated:	- Met requirements of Medacta Test Protocol IL07.09.629 rev 0 and Medacta B.2, and Test Report ENDOLAB report: 167 200908 60 239-rev0 167 201002 60 242-rev0
- Fatigue testing
Coatings (referenced from predicate device GMK Total Knee System):	- Met requirements, previously cleared for GMK Total Knee System (TiNbN) Coating, K202684
- Third body wear test	- Met requirements, previously conducted on predicate devices and reviewed as part of Shoulder System K170452, K193175, K170910
System (referenced from predicate devices):
- Wear test
- Geometrical Analysis
- Micromotion assessments
Biocompatibility:	- Met requirements, conducted according to European Pharmacopoeia §2.6.14 (equivalent to USP <85>), USP <151>, ISO 10993 series and FDA Biocompatibility Guidance document
- Pyrogenicity (Bacterial Endotoxin Test, Pyrogen test)
- Biocompatibility assessment (ISO 10993 series, FDA guidance)

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

This document describes non-clinical bench testing (mechanical, material, and biocompatibility tests) rather than a clinical study with a "test set" of patient data. Therefore, "sample size" here refers to the number of implants or material samples tested. The specific number of samples for each test (e.g., how many humeral heads for pull-off testing) is not explicitly stated in this summary, only the test protocols.

There is no "data provenance" in terms of patient data (country, retrospective/prospective) because this is not a study on patient data.

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)

This is not applicable. Ground truth, in the context of this 510(k), relates to validation against established engineering, material science, and biocompatibility standards, not expert medical diagnoses.

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

This is not applicable. Adjudication methods are typically used for clinical review of images or patient outcomes, not for mechanical bench testing.

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

This is not applicable. This submission is for a physical implant (shoulder prosthesis components) and does not involve AI or human readers. The document explicitly states: "No clinical studies were conducted."

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

This is not applicable. There is no algorithm.

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

The "ground truth" for this regulatory submission is adherence to established international and national standards (e.g., ISO 7206-4, ASTM F2009-11, European Pharmacopoeia, USP, ISO 10993 series) and the results of bench testing. The success criteria are meeting the performance specifications outlined in these standards and the internal test protocols.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI or machine learning device.

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

This is not applicable. There is no "training set."

Summary

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March 2, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & 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.

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

Re: K203755

Trade/Device Name: Shoulder System - TiNbN Coating Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, MBF, HSD Dated: December 21, 2020 Received: December 23, 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 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

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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 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,

Michael Owens 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)

K203755

Device Name Shoulder System - TiNbN Coating

Indications for Use (Describe)

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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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 and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director of Quality and Regulatory, Medacta USA Date Prepared: December 22, 2020 Date Revised: March 2, 2021

II. Device

Device Proprietary Name:	Shoulder System - TiNbN Coating
Common or Usual Name:	Shoulder Prosthesis
Classification Name:	Shoulder joint metal/polymer/metal nonconstrained orsemiconstrained porous-coated uncemented prosthesis
	Shoulder joint metal/polymer semi-constrained cementedprosthesis
	Shoulder joint humeral (hemi-shoulder) metallic uncementedprosthesis
Primary Product Code:	PHX
Secondary Product Code:	KWS, MBF, HSD
Regulation Number:	21 CFR 888.3660, 21CFR 888.3670, 21 CFR 888.3690
Device Classification	II

Predicate Device III.

Substantial equivalence is claimed to the following devices:

Primary predicate device:

Lateralized Glenosphere (Medacta Shoulder Reverse System), K193175, Medacta ● International
Additional predicate device:
Glenosphere (Medacta Shoulder Reverse System), K170452, Medacta International
Humeral Head (Medacta Shoulder Anatomical System), K170910, Medacta International ●
GMK Total Knee System (TiNbN) Coating, K202684, Medacta International ●

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. Medacta Shoulder System Short Humeral Diaphysis, K180089, Medacta International

Device Description IV.

Shoulder System - TiNbN Coating includes the following implants:

. Humeral Head TiNbN Coating (10 sizes, Ø 40 mm to Ø 58 mm)
. Lateralized Glenosphere TiNbN Coating implants (9 sizes) and
Glenosphere implants TiNbN Coating subject of this submission are comprised of the following products (9 sizes):
- Size Ø 32: to be coupled with Medacta Glenoid Baseplate Ø 22 or Ø 24.5mm o
- Size Ø 36: to be coupled with Medacta Glenoid Baseplate Ø 22 or Ø 24.5 or Ø27mm O
- Size Ø 39: to be coupled with Medacta Glenoid Baseplate Ø 24.5 or Ø27mm o
- Size Ø 42: to be coupled with Medacta Glenoid Baseplate Ø 24.5 or Ø27mm O

V. Indications for Use

The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo. The glenoid component is intended for cemented application. The humeral stems are intended for cementless use.

The Medacta Anatomic Shoulder Prosthesis - Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

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The glenoid component is intended for cemented application. The humeral short stem is intended for cementless use.

The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stems are intended for cemented or cementless use.

Comparison of Technological Characteristics VI.

The Shoulder System - TiNbN Coating and the predicate devices Shoulder System (K170452. K193175. K170910) share the following characteristics:

indication for use ●
design;
fixation
substrate material;
device usage:
sterility:
shelf life: and ●
packaging.

The Shoulder System - TiNbN Coating differs from the predicate devices Shoulder System (K170452. K193175. K170910) in relation to the coating only as the subject devices have a TiNbN coating while the predicate devices have no coating.

The Shoulder System - TiNbN Coating has the same coating cleared for GMK Total Knee System (TiNbN) Coating, K202684.

The Shoulder System Short Humeral Diaphysis (previously cleared via K180089) is utilized with the afore mentioned shoulder system components.

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VII. Performance Data

Based on the risk analysis, testing was conducted according to written protocols. The following tests are being provided in support of a substantial equivalence determination:

Non-Clinical Studies:

. PERFORMANCE TESTING

Anatomical humeral head TiNbN coated

0 Pull-off testing, according to Medacta Test Protocol IL 07.09.631 rev 0 and Medacta Test Report B.3 and ENDOLAB report 167 200908 60 238-rev 0 part 1 ASTM F2009-11: Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
Fatigue testing, according to Medacta Test Protocol IL07.09.630 rev 0 and Medacta o Test Report B.1, and ENDOLAB report: 167 200908 60 238-rev 0 part 2 ISO 7206-4:2010(E): "Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components."

"ASTM F1378-17: Standard specifications for shoulder prosthesis"

Glenosphere TiNbN coated

Fatigue testing, according to Medacta Test Protocol IL07.09.629 rev 0 and Medacta o B.2, and Test Report ENDOLAB report: 167 200908 60 239-rev0 167 201002 60 242-rev0
The following performance test was previously conducted on the predicate devices and reviewed as part of the GMK Total Knee System (TiNbN) Coating, K202684:
Third body wear test
The following performance tests were previously conducted on the predicate devices and reviewed as part of the Shoulder System K170452, K193175, K170910:
Wear test
Geometrical Analysis ●

The following performance tests were previously conducted on the predicate devices and reviewed as part of the Shoulder System K170452, K193175:

Micromotion assessments

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PYROGENICITY ●
- Bacterial Endotoxin Test (LAL test) was conducted according to European O Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85>)
- Pyrogen test according to USP chapter <151> for pyrogenicity determination O
- The subject devices are not labeled as non-pyrogenic or pyrogen free O
BIOCOMPATIBILITY ●
- Biocompatibility assessment and related testing as per ISO 10993 series and FDA O Biocompatibility Guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

Clinical Studies

No clinical studies were conducted

VIII. Conclusion

Based on the above information, the Shoulder System - TiNbN Coating implants can be considered 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 Shoulder System - TiNbN Coating implants are as safe and effective as the predicate devices, Shoulder System (K170452, K193175, K170910, and K180089).

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”