Catalyst R1 Reverse Shoulder System

K223655 · Catalyst Orthoscience, Inc. · PHX · May 9, 2023 · Orthopedic

Device Facts

• Record ID: K223655
• Device Name: Catalyst R1 Reverse Shoulder System
• Applicant: Catalyst Orthoscience, Inc.
• Product Code: PHX · Orthopedic
• Decision Date: May 9, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 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 Story

Reverse total shoulder prosthesis; inverted articulation design with sphere on glenoid side and mating insert on humeral stem. Used for shoulder joint replacement in patients with non-functional rotator cuff. System includes humeral stems (cemented/uncemented) and glenoid baseplates (uncemented with screws). Modification adds optional sizes of glenospheres and baseplates to existing R1 system. Implanted by orthopedic surgeons in clinical settings to restore joint function, reduce pain, and address bone defects or fractures. Benefits include improved shoulder mobility and pain relief for patients with cuff deficiency.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing only.

Technological Characteristics

Reverse shoulder prosthesis; metal/polymer construction. Components include humeral stems and glenoid baseplates. Mechanical testing performed per ASTM F2028 (dynamic evaluation of glenoid loosening/disassociation) and ASTM F1378 (complete construct fatigue testing).

Indications for Use

Indicated for patients with functional deltoid muscle and grossly deficient rotator cuff experiencing pain and dysfunction due to severe arthropathy, failed prior joint replacement, glenohumeral fractures (trauma/pathologic/tumor), proximal humerus bone defects, non-inflammatory degenerative disease (osteoarthritis/avascular necrosis), inflammatory arthritis (rheumatoid), or functional deformity.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• Catalyst R1 Reverse Shoulder System (K202611, K211991, K213349)

Reference Devices

• DJO Surgical Reverse Shoulder Prosthesis (K092873)
• Tornier Perform Reversed Glenoid (K161742)

Submission Summary (Full Text)

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Image /page/0/Picture/10 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "HUMAN SERVICES-USA" around the edge. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

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

### Re: K223655

Trade/Device Name: Catalyst 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: April 7, 2023 Received: April 10, 2023

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

May 9, 2023

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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 (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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Farzana Digitally signed by Sharmin -S Date: 2023.05.09

Farzana Sharmin, PhD 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

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# Indications for Use

#### K223655

Device Name

Catalyst R1 Reverse Shoulder System

Indications for Use (Describe)

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 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)

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-----------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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| 510(k) Summary | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared: | December 5, 2022 |
| Submitter: | Catalyst OrthoScience, Inc.<br>14710 Tamiami Trail North, Suite 102<br>Naples, FL 34110 |
| Contact: | Dale Davison<br>Sr. VP of Manufacturing & Product Development<br>Catalyst OrthoScience, Inc.<br>1-239-325-9976 ext. 102<br>[e-mail] |
| Proprietary Name: | Catalyst R1 Reverse Shoulder System |
| Common Name: | Shoulder Prosthesis |
| Classification Name: | 21 CFR 888.3660 - Shoulder joint metal/polymer semi-<br>constrained cemented prosthesis<br><br>21 CFR 888.3690 – Shoulder joint humeral (hemi-<br>shoulder) metallic uncemented prosthesis |
| Regulatory Class: | Class II |
| Product Code: | PHX - Shoulder Prosthesis, Reverse Configuration<br><br>HSD – Shoulder Prosthesis, Hemi-, Humeral, Metallic,<br>Uncemented |
| Predicate Device: | Catalyst R1 Reverse Shoulder System (K202611, K211991,<br>K213349) |
| Reference Devices: | DJO Surgical Reverse Shoulder Prosthesis (K092873)<br>Tornier Perform Reversed Glenoid (K161742) |

# 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.

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This submission is to add optional sizes of the glenospheres and baseplates to the R1 Reverse Shoulder System. The additional sizes of the glenospheres and baseplates are a design modification of the glenospheres and baseplates cleared in K202611. The glenospheres and baseplates in this submission are not replacing the glenospheres and baseplates cleared in K202611 but are an additional option and are compatible with all components within the Catalyst R1 Reverse Shoulder System.

# Intended Use / Indications For Use:

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.

### Comparison of Technologies:

The optional glenospheres and baseplates are substantially equivalent to the predicate device regarding intended use and indications, material, and design intent. Any noted differences do not raise different questions of safety and effectiveness, nor are there new technological issues.

### Performance Data / Non-Clinical Testing:

Mechanical tests per ASTM F2028 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation, complete construct fatigue testing per ASTM F1378. and post-fatigue disassembly testing were completed. The results of these tests indicate that the performance of the Catalyst R1 Reverse Shoulder is substantially equivalent to the legally marketed predicate device.

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K223655 Page 3 of 3

# Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst R1 Reverse Shoulder System with the glenosphere and baseplate additions to the predicate device.

# Conclusions:

The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to the legally marketed device predicate. The intended use, indications, materials, size ranges and design intent are all equivalent and any noted differences do not raise different questions of safety and effectiveness.