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 rotator cuff deficient shoulder joint.

The patient's joint must be anatomically 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.

Device Description

The Lateralized Glenosphere are line extensions to the Medacta Shoulder Reverse System (K170452) and are compatible with the other Medacta cleared products Threaded Glenoid Baseplate (K171058), Glenoid Polyaxial Non-Locking Screws (K181826) and the Short Humeral Stem (K180089).

The Lateralized Glenosphere implants 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
Size Ø 36: to be coupled with Medacta Glenoid Baseplate Ø 22 or Ø 24.5 or Ø27mm
Size Ø 39: to be coupled with Medacta Glenoid Baseplate Ø 24.5 or Ø27mm
Size Ø 42: to be coupled with Medacta Glenoid Baseplate Ø 24.5 or Ø27mm

The Lateralized Glenosphere implants are part of the Medacta Shoulder Reverse System. The Medacta Shoulder Reverse System consists of the following components:

Humeral Diaphysis Cemented;
Humeral Diaphysis - Cementless;
Humeral Reverse Metaphysis;
Humeral Reverse HC Liner (also referred to as PE Liner);
Glenoid Baseplate - Pegged;
Glenoid Baseplate Threaded;
Glenosphere;
Glenoid Polyaxial Locking Screw;
Glenoid Polyaxial Non-Locking Screw;
Reverse Metaphysis Screw; and
Glenosphere Screw.

The glenosphere is attached to the glenoid baseplate and secured by means of a taper connection and a fastening screw.

The purpose of the current submission is to gain clearance for the Lateralized Glenospheres, whose center is more lateralized respect to Medacta predicate device Glenosphere (Medacta Shoulder Reverse System - K170452).

The new option of lateralization allows the surgeon to intraoperatively select the desired level of ROM and resulting joint tension based on the patient's anatomy.

The Lateralized Glenosphere is made of CoCrMo ISO 5832-12 (Second Edition 2007-05-01) Implants For Surgery - Part 12: Wrought Cobalt- Chromium-Molybdenum Alloy [Including: Technical Corrigendum 1 (2008)], while the Glenosphere screw packed with the implant is made of Ti alloy (Ti-6A1-4V), 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Lateralized Glenosphere." This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific performance criteria through a study with acceptance criteria in the typical sense of a diagnostic or predictive AI device.

Therefore, the requested information cannot be fully extracted as there is no study that proves the device meets specific acceptance criteria in the context of a diagnostic AI product, because this is a physical implant. The performance data section refers to mechanical tests on the implant itself, not a study of a diagnostic algorithm.

Here's an analysis of what information can be provided based on the input:

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

Based on the document, there isn't a table of acceptance criteria and reported device performance in the way one would describe for a diagnostic AI device (e.g., sensitivity, specificity, accuracy). Instead, there are mechanical tests performed with acceptance criteria based on established standards for shoulder prostheses.

Acceptance Criteria (Based on Standards)	Reported Device Performance (Summary)
ASTM F2028-17: Standards Test Methods For Dynamic Evaluation of Glenoid Loosening or Disassociation	Assessment conducted in reverse configuration with a lateralized glenosphere. (Implied: Met the standard's requirements for glenoid loosening or disassociation)
ASTM F1378-17: Standard Specifications for Shoulder Prosthesis (Fatigue Test)	Fatigue test conducted on threaded glenoid reverse construct with a lateralized glenosphere. (Implied: Met the standard's specifications for fatigue)
European Pharmacopoeia §2.6.14 (equivalent to USP chapter <85>) for Bacterial Endotoxin Test (LAL test)	Bacterial Endotoxin Test conducted. (Implied: Met the standard's requirements for endotoxin levels)
USP chapter <151> for Pyrogen Test	Pyrogen test conducted. (Implied: Met the standard's requirements for pyrogenicity)
Rationale, Lateralized Glenosphere Wear Assessment	Wear assessment conducted. (Implied: Acceptable wear characteristics based on established rationale)

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

Sample Size for Test Set: Not applicable in the context of a clinical test set for diagnostic accuracy. The "test set" here refers to the physical samples of the medical device (Lateralized Glenosphere and associated components) that underwent mechanical testing. The exact number of physical devices or components tested for each mechanical study is not specified in this summary.
Data Provenance: The mechanical tests were conducted in a laboratory setting according to written protocols. There's no information about the country of origin or whether it was retrospective/prospective as it relates to patient data.

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

Not applicable. This device is a physical implant, not a diagnostic AI device requiring expert-established ground truth for a test set. The "ground truth" for the mechanical tests would be the established engineering standards (ASTM, ISO, European Pharmacopoeia, USP) and the physical properties observed during testing.

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

Not applicable. Adjudication methods like 2+1 are used for establishing ground truth in diagnostic studies, not for mechanical testing of physical implants. The "adjudication" for mechanical tests is agreement with the predefined acceptance criteria of 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:

Not applicable. This is not an AI diagnostic device. No human reader studies (MRMC) were conducted as the device is a physical implant.

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

Not applicable. This is not an AI algorithm. The performance data refers to the mechanical integrity and biological safety of the physical medical device itself.

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

The "ground truth" for the performance data is based on recognized engineering standards (ASTM F2028-17, ASTM F1378-17), pharmacopoeia guidelines (European Pharmacopoeia §2.6.14, USP <85>, USP <151>), and design validation reports for the mechanical and biocompatibility aspects of the implant.

8. The sample size for the training set:

Not applicable. This device is a physical implant, not an AI model that requires a training set.

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

Not applicable. As there is no AI model or training set, this question is not relevant.

In summary: The provided document is a 510(k) summary for a physical medical implant. The "acceptance criteria" and "performance data" refer to mechanical and biocompatibility testing against established engineering and medical device standards, not to the performance of a diagnostic or AI-driven system. Therefore, most of the requested information, which is typically relevant for AI/diagnostic device evaluation, is not applicable or provided in this context.

Summary

{0}------------------------------------------------

August 11, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

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

Re: K193175

Trade/Device Name: Lateralized Glenosphere Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, HSD, MBF Dated: July 10, 2020 Received: July 13, 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 801); medical

{1}------------------------------------------------

device reporting (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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-DICE website assistance/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 Michael Owens 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K193175

Device Name Lateralized Glenosphere

Indications for Use (Describe)

The patient's joint must be anatomically 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.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K193175 Page 1 of 4

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 and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director, Quality and Regulatory, Medacta USA Date Prepared: November 15, 2019 Date Revised: August 7, 2020

II. Device

Device Proprietary Name:	Lateralized Glenosphere
Common or Usual Name:	Shoulder Prosthesis, Reverse Configuration
Classification Name:	Shoulder joint metal/polymer semi-constrained cemented prosthesis
Primary Product Code:	PHX
Secondary Product Code:	HSD and MBF
Regulation Number:	21 CFR 888.3660 (Primary), 21 CFR 888.3690 and 21 CFR 888.367
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following devices:

Primary Predicate:
- · Glenosphere (Medacta Shoulder Reverse System), K170452, Medacta International SA;
Reference Device:
- · Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid, K161742, Tornier, Inc.

Device Description IV.

{4}------------------------------------------------

The Lateralized Glenosphere implants 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 ●
. Size Ø 36: to be coupled with Medacta Glenoid Baseplate Ø 22 or Ø 24.5 or Ø27mm
Size Ø 39: to be coupled with Medacta Glenoid Baseplate Ø 24.5 or Ø27mm ●
. Size Ø 42: to be coupled with Medacta Glenoid Baseplate Ø 24.5 or Ø27mm

The Lateralized Glenosphere implants are part of the Medacta Shoulder Reverse System. The Medacta Shoulder Reverse System consists of the following components:

Humeral Diaphysis Cemented; ●
Humeral Diaphysis - Cementless;
Humeral Reverse Metaphysis; ●
Humeral Reverse HC Liner (also referred to as PE Liner); ●
. Glenoid Baseplate - Pegged;
Glenoid Baseplate Threaded; ●
Glenosphere; ●
. Glenoid Polyaxial Locking Screw;
. Glenoid Polyaxial Non-Locking Screw;
Reverse Metaphysis Screw; and ●
Glenosphere Screw. ●

The glenosphere is attached to the glenoid baseplate and secured by means of a taper connection and a fastening screw.

The new option of lateralization allows the surgeon to intraoperatively select the desired level of ROM and resulting joint tension based on the patient's anatomy.

The Lateralized Glenosphere implants are substantially equivalent to Medacta predicate device Glenosphere implants (K170452) and to competitor predicate device Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid, K161742, Tornier, Inc.

{5}------------------------------------------------

V. Indications for 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 rotator cuff deficient 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.

VI. Comparison of Technological Characteristics

The Lateralized Glenosphere and the main predicate device (cleared within Medacta Shoulder Reverse System) K170452, Medacta International SA share the following characteristics:

indications for use; ●
material of construction:
sizes
eccentricity of the COR (Center Of Rotation);
biocompatibility;
device usage:
sterility;
shelf life; and
packaging.

The Lateralized Glenosphere is technologically different from the main predicate device as follows:

lateralization of the COR.
The subject Lateralized Glenosphere has the same technological characteristics of the Medacta predicate device Glenosphere (cleared within Medacta Shoulder Reverse System) K170452, with the only exception of the grade of lateralization of the COR, feature shared with the other predicate AEQUALIS™ REVERSED II Shoulder Prosthesis (K112144). This new option of lateralization allows the surgeon to intraoperatively select the desired level of ROM and resulting joint tension based on the patient's anatomy.

Biocompatibility testing conducted on the main predicate device for the same materials supports the biological safety of the Lateralized Glenosphere. Subject and predicate devices are manufactured from the following material: CoCrMo ISO 5832-12 (Second Edition 2007-05-01) Implants For Surgery – Part 12: Wrought Cobalt- Chromium-Molybdenum Alloy [Including: Technical Corrigendum 1 (2008)], 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.

{6}------------------------------------------------

VII. Performance Data

Testing was conducted according to written protocols with acceptance criteria that were based on standards. The following mechanical studies were performed in substantial equivalence determination:

Non-Clinical Studies:

Characterization Tests .
- o Design Validation Report.
Performance Tests
- Assessment In Reverse Configuration With A Lateralized o Micromotions Glenosphere: ASTM F2028-17: Standards Test Methods For Dynamic Evaluation of Glenoid Loosening or Disassociation;
- Fatigue Test On Threaded Glenoid Reverse Construct With A Lateralized о Glenosphere: ASTM F1378-17 - Standard Specifications for Shoulder Prosthesis; and
- Rationale, Lateralized Glenosphere Wear Assessment. o
Pyrogenicity
- Bacterial Endotoxin Test (LAL test) was conducted according to European o 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

Clinical Studies:

No clinical studies were conducted. ●

VIII. Conclusion

Based on the above information, the Lateralized Glenospheres 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 Lateralized Glenosphere implants are as safe and effective as the predicate devices Medacta standard Glenosphere cleared under Medacta Shoulder Reverse System K170452 (predicate device) and Tornier AEQUALIS™ REVERSED II Shoulder Prosthesis (K112144).

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.”