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 cuffshoulder 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 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 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.

Device Description

The Humeral Eccentric Reverse Metaphysis is a line extension to the Medacta Shoulder Reverse System (K170452) and it is compatible with the other Medacta cleared products: Humeral Reverse PE Liner (K170452), Humeral Diaphysis (K170452), Short Humeral Diaphysis (K180089), Long Humeral Diaphysis (K192967).

The Humeral Eccentric Reverse Metaphysis implant subject of this submission is comprised of the following size: Diameter= Ø37.5mm Offset= 3mm.

The Humeral Eccentric Reverse Metaphysis 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;
. Lateralized Glenosphere
Glenoid Polyaxial Locking Screw;
Glenoid Polyaxial Non-Locking Screw; ●
Reverse Metaphysis Screw; and ●
Glenosphere Screw.

The Humeral Diaphysis and the Humeral Reverse Metaphysis (standard or eccentric) are intended to be assembled together by means of a cylindrical driven-fit coupling and tightened by the Reverse Metaphysis Screw. The Humeral Reverse HC Liner is intended to be coupled by means of an embedded clipping mechanism with the Humeral Reverse Metaphysis (standard or eccentric).

The purpose of the current submission is to gain clearance for the Humeral Eccentric Reverse Metaphysis.

The main body of Humeral Eccentric Reverse Metaphysis is made of Ti alloy (Ti-6A1-4V), according to ISO 5832-3:2016 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy.

The screw of the Reverse Metaphysis (standard or eccentric), packaged with main body, is made of Ti alloy (Ti-6A1-4V), according to ISO 5832-3:2016 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy, enhanced with Type-II anodization.

AI/ML Overview

The document provided is a 510(k) premarket notification for a medical device (Humeral Eccentric Reverse Metaphysis). It concerns the regulatory approval process for a new medical device, demonstrating its substantial equivalence to existing devices. Therefore, it does not describe acceptance criteria for, or the results of, a study proving device performance in the way a clinical trial or AI/ML performance study would.

Instead, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the regulatory requirements for demonstrating substantial equivalence to a predicate device. This is primarily done through non-clinical performance testing and comparison of technological characteristics.

Here's how to interpret the provided information based on the request:

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

The document doesn't provide a direct table of "acceptance criteria" and "reported device performance" in a quantitative sense as might be seen for diagnostic accuracy or clinical outcomes. Instead, the acceptance criteria are implicitly that the device performs mechanically and biologically comparably to the predicate devices and meets relevant mechanical standards.

Acceptance Criterion (Regulatory)	Reported Device Performance (Non-Clinical)
Material Equivalence: Material composition is the same as predicate device(s).	"The main body of Humeral Eccentric Reverse Metaphysis is made of Ti alloy (Ti-6A1-4V), according to ISO 5832-3:2016... The screw...is made of Ti alloy (Ti-6Al-4V), according to ISO 5832-3:2016...enhanced with Type-II anodization." Similar for predicate.
Biocompatibility: Device materials are biocompatible.	"The biocompatibility of the Humeral Eccentric Reverse Metaphysis was evaluated based on using identical materials and manufacturing processes as a previously cleared device."
Mechanical Performance: Meets established mechanical safety and performance standards benchmarked against predicate.	"Testing was conducted according to written protocols with acceptance criteria that were based on standards." Specifically: "Static Torsion test" and "Rationale, Humeral Eccentric Reverse Metaphysis Worst Case Assessment."
Pyrogenicity: Device is non-pyrogenic if applicable.	"Bacterial Endotoxin Test (LAL test) was conducted according to European Pharmacopoeia §2.6.14...and pyrogen test according to USP chapter <151>".
Indications for Use: The device shares the same indications for use as the predicate device.	"The Humeral Eccentric Reverse Metaphysis and the main predicate device ... share the following characteristics: indications for use". The text lists the indications for use on page 3.

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

Sample Size for Test Set: For non-clinical (mechanical) testing, sample sizes are not explicitly stated in the summary, but such tests typically involve a specific number of components or assemblies required by the test standard (e.g., ISO, ASTM). The document refers to "written protocols with acceptance criteria that were based on standards," implying standard-mandated sample sizes were used.
Data Provenance: Not applicable in the context of clinical data for this device submission. The data is from non-clinical laboratory mechanical and material tests performed to specific standards (e.g., ISO 5832-3:2016, European Pharmacopoeia §2.6.14, USP chapter <151>).

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 question is not applicable for this type of submission. "Ground truth" established by experts (like radiologists) is relevant for diagnostic devices or those involving interpretation of medical images/data. This device is a shoulder prosthesis, and its evaluation for regulatory clearance relies on engineering, material science, and mechanical testing, not expert consensus on clinical diagnoses or interpretations.

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

This question is not applicable. Adjudication methods (like 2+1 physician review) are used in clinical studies, particularly for endpoints that require expert consensus or evaluation. This submission relies on non-clinical engineering and material testing, where the "ground truth" is determined by physical measurements and adherence to technical specifications and standards, not human consensus on clinical findings.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving AI/ML assistance for human readers (e.g., radiologists interpreting images). This device is a shoulder prosthesis, not a diagnostic tool, and its submission did not involve such studies.

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

No, this is not applicable. A standalone performance evaluation (algorithm only) is relevant for AI/ML-driven diagnostic or analytical devices. This device is a mechanical implant; there is no algorithm involved in its direct function or evaluation for regulatory clearance.

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

The "ground truth" for the non-clinical tests is based on engineering specifications, material standards, and benchmarked mechanical performance against established predicate devices and relevant ISO/USP standards. For example, the ground truth for a static torsion test is whether the device withstands specified forces without failure, as per the test protocol and standard acceptance criteria. For material composition, the ground truth is adherence to the chemical specifications of Ti-6Al-4V.

8. The sample size for the training set

This question is not applicable. "Training set" refers to data used to train AI/ML models. This submission is for a mechanical orthopedic implant and does not involve AI/ML.

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

This question is not applicable for the same reasons as #8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.

Medacta International SA % Chris Lussier Senior Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 83118

Re: K210207

Trade/Device Name: Humeral Eccentric Reverse Metaphysis 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 Dated: January 25, 2021 Received: January 26, 2021

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

March 26, 2021

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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 (OS) 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) K210207

Device Name

Humeral Eccentric Reverse Metaphysis

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.

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.

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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510(k) Summary

Submitter I.

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, Quality and Regulatory, Medacta USA Date Prepared: January 25, 2021 Date Revised: March 26, 2021

II. Device

Device Proprietary Name:	Humeral Eccentric Reverse Metaphysis
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:	KWS , MBF
Regulation Number:	21 CFR 888.3660 and 21 CFR 888.3670
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following devices:

Primary Predicate:
- · Humeral reverse metaphysis (Medacta Shoulder Reverse System), K170452, Medacta International SA;

> Reference Device:

· Delta Xtend™ Reverse Shoulder System, K120174, DePuy Orthopaedics, Inc.
· Short Humeral Stem, K180089, Medacta International
· Medacta Shoulder System Long Stem Shoulder, K192967, Medacta International

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Device Description IV.

The Humeral Eccentric Reverse Metaphysis implant subject of this submission is comprised of the following size: Diameter= Ø37.5mm Offset= 3mm.

The Humeral Eccentric Reverse Metaphysis 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;
. Lateralized Glenosphere
Glenoid Polyaxial Locking Screw;
Glenoid Polyaxial Non-Locking Screw; ●
Reverse Metaphysis Screw; and ●
Glenosphere Screw.

The purpose of the current submission is to gain clearance for the Humeral Eccentric Reverse Metaphysis.

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The Humeral Eccentric Reverse Metaphysis, implant is substantially equivalent to Medacta predicate device Humeral reverse metaphysis (K170452) and to competitor predicate device Delta Xtend™ Reverse Shoulder System, (K120174) Depuy Orthopaedics, Inc.

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 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 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.

VI. Comparison of Technological Characteristics

The Humeral Eccentric Reverse Metaphysis and the main predicate device Humeral reverse metaphysis (cleared within Medacta Shoulder Reverse System) K170452. Medacta International SA share the following characteristics:

indications for use; ●
substrate material (Ti6Al4V): ●
Humeral reverse construct: ●
diameter:
. humeral reverse HC liner - Inclination
biocompatibility:
device usage:
sterility: ●
. shelf life; and
packaging. .

The Humeral Eccentric Reverse Metaphysis is technologically different from the main predicate device as follows:

Connection between Metaphysis and Diaphysis (there is no reverse indexing pin) ●
Numbers of Evelets ●

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. Coating (there is no coating)
. Size range

The subject Humeral Eccentric Reverse Metaphysis has the same technological characteristics of the Medacta predicate device Humeral Reverse Metaphysis (cleared within Medacta Shoulder Reverse System) K170452, with the only exception of the offset between Metaphysis and Diaphysis, feature shared with the other predicate Delta Xtend™ Reverse Shoulder System, K120174, DePuy Orthopaedics, Inc.

The biocompatibility of the Humeral Eccentric Reverse Metaphysis was evaluated based on using identical materials and manufacturing processes as a previously cleared device. The subject and predicate devices are manufactured from the following material: Ti alloy (Ti-6AI-4V), according to ISO 5832-3:2016 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy.

While the screw of the Reverse Metaphysis (standard or eccentric), packed with the main body is made of Ti alloy (Ti-6Al-4V), according to ISO 5832-3:2016 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy enhanced with Type-II anodization.

Performance Data VII.

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 ●
- Static Torsion test o
- Rationale, Humeral Eccentric Reverse Metaphysis Worst Case 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 Humeral Eccentric Reverse Metaphysis is substantially equivalent to the identified predicate devices.

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Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics, as well as performance evaluations. The Humeral Eccentric Reverse Metaphysis implants are substantially equivalent to the predicate devices Medacta Humeral Reverse Metaphysis cleared under Medacta Shoulder Reverse System K170452 (predicate device).

Regulation Number and Section

N/A