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.

The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System can be used to provide additional fixation.

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 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 Glenoid Reconstruction System is a Medacta Shoulder System line extension to provide a larger product offering. It includes GRS baseplates and central screws, sterile implantable devices used to replace only the glenoid side of the gleno-humeral joint in a shoulder reverse configuration.

The GRS baseplate, intended for cementless application, is designed to be fixed into the glenoid bone by means of both a press-fit central post and Glenoid Polyaxial Screws. If desired, a GRS Central Screw can be used to provide additional stability. The GRS baseplate is designed to provide an interface for glenosphere coupling.

The subject baseplate is available in two taper diameters (024.5 and 027) with two different lengths (20 and 30 mm) of the central post and 3 lateralization options (0 mm, +3 mm and +6 mm). It is made of Ti6A17Nb according to ISO 5832-11 and double coated with Ti coating according to ASTM F1580-18 and HA coating according to ASTM F1185-03.

The GRS central screw is available in 4 different lengths, from 15 to 30 mm and it is made of Ti6Al4V according to ISO 5832-3.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Glenoid Reconstruction System, specifically for new GRS baseplates and central screws. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials with acceptance criteria based on patient outcomes.

Therefore, the input document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device.

Here's why and what can be extracted from the document in relation to device performance and testing:

Why the requested information is not present:

Device Type: The Glenoid Reconstruction System is a medical implant (shoulder prosthesis components), not an AI/ML-powered diagnostic or therapeutic device. The types of evaluations, acceptance criteria, and studies are fundamentally different.
Regulatory Pathway (510(k)): A 510(k) submission primarily relies on demonstrating that a new device is "substantially equivalent" to an existing legally marketed device (the predicate). This often involves comparing technological characteristics and performing bench testing (non-clinical studies) to ensure it performs as intended and is as safe and effective as the predicate. Clinical studies are often not required for 510(k)s, especially for incremental changes or extensions of existing product lines, which is the case here.
Focus on Performance Data: The "Performance Data" section lists non-clinical studies (design validation, fatigue testing, micromotion assessment, static tests, material characterization, biocompatibility, shelf-life). These are engineering and material science tests, not AI/ML performance metrics like sensitivity, specificity, or AUC.

What information can be extracted/inferred related to the device's performance, but not in the AI/ML context you've asked for:

No Acceptance Criteria for AI/ML performance: As it's not an AI/ML device, there are no acceptance criteria related to metrics like sensitivity, specificity, accuracy, etc.
No Reported Device Performance (as AI/ML metrics): The document doesn't report performance in terms of AI/ML metrics.
Sample Size (for an AI/ML test set): Not applicable. The "test set" here refers to physical components undergoing engineering tests.
Data Provenance (for an AI/ML test set): Not applicable.
Number of experts / Adjudication Method: Not applicable. These relate to establishing ground truth for AI/ML studies. The "experts" involved here would be materials scientists or mechanical engineers for the non-clinical tests.
Multi-reader Multi-case (MRMC) study: Not applicable. This is specific to diagnostic imaging interpretation, often with human interpretation.
Standalone (algorithm-only) performance: Not applicable.
Type of Ground Truth (for AI/ML): Not applicable. The "ground truth" for the a glenoid reconstruction system is established through engineering principles, material standards, and biomechanical testing. For example, for fatigue testing, the ground truth is whether the component withstands a specified number of cycles at a certain load without failure, according to a standard. For material characterization, the ground truth is the chemical composition and microstructure matching specifications.
Training Set Sample Size & Ground Truth (for AI/ML): Not applicable.

In summary, the provided document describes the regulatory approval of a physical medical implant, not an AI/ML-powered device. Therefore, it does not contain the specific information you've requested regarding AI/ML acceptance criteria and performance studies.

Summary

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November 23, 2022

Image /page/0/Picture/1 description: The image contains 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 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 S.A. Chris Lussier Senior Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118

Re: K213459

Trade/Device Name: Glenoid Reconstruction System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, KWS, HSD, MBF Dated: October 26, 2022 Received: October 28, 2022

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

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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 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,

Victoria A. Lilling -S Lilling ate: 2022.11.23 19:03:24 -05'00

Victoria Lilling, M.D. Assistant Division Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213459

Device Name Glenoid Reconstruction System

Indications for Use (Describe)

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 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.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K213459 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 and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director of Quality and Regulatory, Medacta USA Date Prepared: October 25, 2021 Date Revised: November 23, 2022

II. Device

Device Proprietary Name:	Glenoid Reconstruction System
Common or Usual Name:	Shoulder Prosthesis, Reverse Configuration
Classification Name:	Shoulder joint metal/polymer semi-constrained cementedprosthesis
Primary Product Code	PHX
Secondary Product Code:	KWS, HSD, MBF
Regulation Number:	21 CFR 888.3660, 21 CFR 888.3690, 21 CFR 888.3670
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following devices:

Primary predicate device

Aequalis Perform Reversed, K161742, Wright Medical A
Additional predicate devices
Comprehensive Reverse Shoulder, K120121, Biomet Manufacturing Corp.
Reverse Shoulder Prosthesis, K100741, Encore Medical L.P.
Encore Reverse Shoulder Prosthesis (RSP), K051075, Encore Medical L.P.

Reference device

Medacta Shoulder System, K170452, Medacta International SA

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IV. Device Description

The GRS central screw is available in 4 different lengths, from 15 to 30 mm and it is made of Ti6Al4V according to ISO 5832-3.

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 deficient rotator cuff shoulder ioint. The patient's ioint 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.

VI. Comparison of Technological Characteristics

The subject and predicate devices (K161742 and K120121) are substantially equivalent with regards to the following characteristics:

general design; ●
lateralization (except the predicate K120121); ●
fixation; ●

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K213459 Page 3 of 4

biocompatibility; ●
. device usage;
sterility;
shelf-life; and ●
packaging. ●

The subject implants differ from the predicate devices (K161742 and K120121) as follows:

baseplate taper and central post diameters; ●
baseplate material and finishing: and ●
baseplate central post length and central screw lengths. ●

Discussion

Medacta International SA has not made any change to the indications for use, general design and shape, fixation, device usage, biocompatibility, sterility, shelf life, and packaging of the subject devices respect to the predicate devices.

Based on the comparison of technological characteristics and performance data provided within this submission, the data supports the substantial equivalence of the Glenoid Reconstruction System implants to the identified predicate devices.

VII. Performance Data

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

Non-Clinical Studies

DESIGN VALIDATION ●
- O Glenoid Reconstruction System Design Validation
PERFORMANCE TESTING .
- Fatigue testing on glenoid reconstruction system O
- Micromotion assessment on Glenoid reconstruction system according to ASTM F2028-17 O
- GRS Central Screw Static test according to ASTM F543-17 O
- Characterization Report "Y367" Titanium + "Osprovit" Hydroxyapatite double coating on O GRS Glenoid baseplate component
- Scanning electron microscopy pictures of the "Y367" Titanium + "Osprovit" HA implant O surfaces of the GRS Glenoid baseplate
- Cross sectioned area of "Y367" Titanium + "Osprovit" HA implant surfaces of the GRS о Glenoid baseplate
- Rationale comparison between features of the Hydroxyapatite Osprovit coating deposited on o the Medacta GRS Glenoid baseplate and on planar samples made of Ti6Al7Nb, based on XRD analyses

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K213459 Page 4 of 4

PYROGENICITY evaluation .
BIOCOMBATIBILITY evaluation .
. SHELF-LIFE evaluation

Clinical Studies:

. No clinical studies were conducted.

VIII. Conclusion

The information provided above supports that the Glenoid Reconstruction Systems implants are substantially equivalent to the predicate devices.

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.”