The Catalyst R1 Reverse Shoulder System is a reverse total shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:

· Severe arthropathy with a grossly deficient rotator cuff;

· Previously failed joint replacement with a grossly deficient rotator cuff;
· Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture,

displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection:

· Bone defect in proximal humerus;
Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/ or glenoid:
· Inflammatory arthritis including rheumatoid arthritis;
· Correction of functional deformity

The humeral stems are intended for cemented or uncemented applications.

The glenoid baseplate is intended for uncemented use with the addition of screws for fixation.

Device Description

The Catalyst R1 Reverse Shoulder System is a total shoulder prosthesis designed for use in patients with a non-functional rotator cuff. The articulation of this reverse design is inverted compared to a traditional anatomic total shoulder prosthesis, where the articulating sphere is on the glenoid side of the joint, and the mating insert is fixed into the humeral stem implant.

The humeral implant system consists of humeral stems and polyethylene inserts. The stem implants are manufactured from Ti-6Al-4V ELI conforming to ASTM F136 with a porous structure on the proximal portion. The humeral stems are offered in short and long stem configurations to accommodate varying bone geometries. The humeral articulating inserts are manufactured from UHMWPE conforming to ASTM F648. They have a concave bearing geometry that radially matches the different sized glenospheres and are offered in varying thicknesses to achieve stability of the glenohumeral joint.

The glenoid implant system consists of a central baseplate, glenosphere, fixation components, and locking components. The central baseplate is a circular disc that rests against the glenoid bone and is secured to the bone using up to four peripheral screws and either a central screw or post. The baseplate is manufactured from Ti-6AI-4V ELI conforming to ASTM F136 with a titanium plasma spray on the bone facing surface. The baseplate is offered in standard and augmented configurations. The Co-Cr-Mo glenospheres are manufactured from CoCrMo conforming to ASTM F1537 and are secured to the baseplate by a taper lock, and with an additional locking screw. The fixation components are manufactured from Ti-6Al-4V ELI conforming to ASTM F136.

AI/ML Overview

The provided text describes a medical device submission (K202611) for the Catalyst OrthoScience R1 Reverse Shoulder System. It is a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria through extensive clinical studies.

Therefore, the document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst R1 Reverse Shoulder System to the predicate devices."

This means that a study proving the device meets acceptance criteria as typically understood for new major medical devices (e.g., in terms of clinical outcomes, diagnostic performance, or comparative effectiveness with human readers for AI) was not performed or required for this 510(k) clearance.

Instead, the acceptance criteria for this device are based on demonstrating equivalence to already legally marketed predicate devices through:

Mechanical and materials testing: Ensuring the device meets relevant ASTM and ISO standards for its intended use.
Design and intended use similarity: Showing that the new device's design, materials, indications for use, and size ranges are comparable to predicate devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission focused on substantial equivalence and not a de novo clinical trial, the "acceptance criteria" are the demonstration of similarity to predicate devices and performance in non-clinical testing.

Acceptance Criteria (Demonstrated Equivalence/Performance of Non-Clinical Testing)	Reported Device Performance
Substantial Equivalence:
Intended Use and Indications	The Catalyst R1 Reverse Shoulder System's intended use and indications for use are substantially equivalent to the predicate devices (Encore Medical (DJO) Altivate Reverse Shoulder System, FX Solutions Humelock Reversed Shoulder, Arthrex Univers Revers Modular Glenoid). Indications include severe arthropathy, failed joint replacement, fracture, bone defect, non-inflammatory degenerative disease, inflammatory arthritis, and correction of functional deformity, all with a grossly deficient rotator cuff and functional deltoid muscle.
Materials	The device uses the same materials as predicate devices: Ti-6Al-4V ELI (humeral stems, baseplate, fixation components), UHMWPE (humeral articulating inserts), and CoCrMo (glenospheres). Conforms to ASTM F136, ASTM F648, and ASTM F1537 respectively.
Size Ranges	Same size ranges as predicate devices.
Design Intent	Same design intent as predicate devices (inverted articulation for reverse total shoulder replacement).
Non-Clinical Performance:
Range of motion analyses	Completed. Results indicate adequate performance for intended use.
Complete construct fatigue testing (per ASTM F1378)	Completed. Results indicate adequate performance for intended use.
Post-fatigue disassembly testing	Completed. Results indicate adequate performance for intended use.
Testing of glenoid stability (per ASTM F2028)	Completed. Results indicate adequate performance for intended use.
Chemical characterization (per ISO 10993 Part 18)	Conducted on implant materials.
Cytotoxicity testing	Conducted on implant materials.
Pyrogenicity testing	Conducted on implant materials. Met the recommended limit of <20 EU/device.
Overall Conclusion	"The testing performed and results indicate that the Catalyst R1 Reverse Shoulder System is equivalent to the predicate devices." "Any noted differences do not raise new types of safety and effectiveness questions, nor are there new technological issues."

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

Not applicable. No clinical "test set" in the context of device performance or diagnostic accuracy was used. The focus was on non-clinical testing and comparison to predicates.

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

Not applicable. No expert review for ground truth on a clinical test set was required or performed for this 510(k) submission.

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

Not applicable. No clinical test set or adjudication process was described.

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 device is a shoulder prosthesis, not an AI-assisted diagnostic tool or a device where human reader improvement with AI is relevant.

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

Not applicable. This device is a shoulder prosthesis, not an algorithm.

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

Not applicable in the sense of clinical "ground truth" for diagnostic or predictive accuracy. The "ground truth" for this 510(k) submission is instead the established performance and safety profiles of the legally marketed predicate devices, against which the new device demonstrated substantial equivalence through non-clinical testing.

8. The sample size for the training set

Not applicable. No "training set" in the context of AI or clinical model development was used.

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

Not applicable.

Summary

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February 12, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

Catalyst OrthoScience, Inc. Dale Davison Sr. VP of Manufacturing & Product Development 14710 Tamiami Trail North Naples, Florida 34110

Re: K202611

Trade/Device Name: Catalyst OrthoScience R1 Reverse Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, HSD Dated: January 12, 2021 Received: January 13, 2021

Dear Dale Davison:

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 device reporting of medical device-related adverse events) (21 CFR 803) for

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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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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) K202611

Device Name

Catalyst R1 Reverse Shoulder System

Indications for Use (Describe)

· Severe arthropathy with a grossly deficient rotator cuff;

· Previously failed joint replacement with a grossly deficient rotator cuff;
· Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture,

displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection:

· Bone defect in proximal humerus;
Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/ or glenoid:
· Inflammatory arthritis including rheumatoid arthritis;
· Correction of functional deformity

The humeral stems are intended for cemented or uncemented applications.

The glenoid baseplate is intended for uncemented use 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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Image /page/3/Picture/1 description: The image shows the logo for Catalyst OrthoScience. The logo features a stylized blue "C" shape above the word "CATALYST" in a bold, sans-serif font. Below "CATALYST" is the word "OrthoScience" in a smaller, lighter font, with a registered trademark symbol next to it.

510(k) Summary
Prepared:	February 12, 2021
Submitter:	Catalyst OrthoScience, Inc.14710 Tamiami Trail North, Suite 102Naples, FL 34110
Contact:	Dale DavisonSr. VP of Manufacturing & Product DevelopmentCatalyst OrthoScience, Inc.1-239-325-9976 ext. 102ddavison@catalystortho.com
Proprietary Name:	Catalyst R1 Reverse Shoulder System
Common Name:	Shoulder Prosthesis
Classification Name:	21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrainedcemented prosthesis
	21 CFR 888.3690 – Shoulder joint humeral (hemi-shoulder)metallic uncemented prosthesis
Regulatory Class:	Class II
Product Code:	PHX - Shoulder Prosthesis, Reverse Configuration
	HSD - Shoulder Prosthesis, Hemi-, Humeral, Metallic, Uncemented
SubstantiallyEquivalent Devices:	Primary Predicate:Encore Medical (DJO) Altivate Reverse Shoulder System (K141990, K172351 and K190290) Secondary Predicates: FX Solutions Humelock Reversed Shoulder (K162455) Arthrex Univers Revers Modular Glenoid

Device Description:

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Image /page/4/Picture/1 description: The image contains the logo for Catalyst OrthoScience. The logo features a stylized, abstract symbol above the company name. The symbol is composed of three curved shapes in shades of blue and teal, arranged in a circular formation. Below the symbol, the word "CATALYST" is written in a bold, sans-serif font, and beneath that, "OrthoScience" is written in a smaller, lighter font.

Intended Use / Indications For Use:

· Severe arthropathy with a grossly deficient rotator cuff;
· Previously failed joint replacement with a grossly deficient rotator cuff;
· Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
· Bone defect in proximal humerus;
· Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid;
· Inflammatory arthritis including rheumatoid arthritis;
· Correction of functional deformity

The humeral stems are intended for cemented or uncemented applications.

The glenoid baseplate is intended for uncemented use with the addition of screws for fixation.

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Image /page/5/Picture/1 description: The image shows the logo for Catalyst OrthoScience. The logo features a stylized letter 'C' formed by two curved shapes in different shades of blue and teal. Below the symbol, the word 'CATALYST' is written in a bold, sans-serif font. Underneath 'CATALYST', the words 'ORTHOSCIENCE' are written in a smaller, lighter font.

Comparison of Technologies/Substantial Equivalence:

The Catalyst R1 Reverse Shoulder System is substantially equivalent to the predicate devices in regards to intended use and indications, materials, size ranges, and design intent. Any noted differences do not raise new types of safety and effectiveness questions, nor are there new technological issues.

Performance Data / Non-Clinical Testing:

Range of motion analyses, complete construct fatigue testing per ASTM F1378, post-fatigue disassembly testing, and testing of glenoid stability per ASTM F2028 were completed. The results of these tests indicate that the performance of the Catalyst R1 Reverse Shoulder is adequate for its intended use. Chemical characterization per ISO 10993 Part 18, Cytotoxicity and Pyrogenicity testing were also conducted on the implant materials. The Catalyst R1 Reverse Shoulder met the recommended pyrogenicity limit of <20 EU/device.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst R1 Reverse Shoulder System to the predicate devices.

Conclusions

The Catalyst R1 Reverse Shoulder System is substantially equivalent to the predicate devices. The subject device has the same design features, uses the same materials, has the same intended use and indications, has the same size ranges, and the same design intent as the predicate devices. Any noted differences do not raise new types of safety and effectiveness questions, nor are there new technological issues. The testing performed and results indicate that the Catalyst R1 Reverse Shoulder System is 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.”