(100 days)
No
The summary describes a mechanical implant for shoulder replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a "replacement of shoulder joints" for "anatomic or reverse arthroplasty," indicating it's used to treat a medical condition by restoring function.
No
The device is a prosthesis designed for replacement of shoulder joints, not for diagnosis.
No
The device description clearly outlines physical components made of materials like Ti-6A1-4V ELI and Co-Cr-Mo alloy, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to replace shoulder joints in anatomic or reverse arthroplasty. This is a surgical procedure performed on the body.
- Device Description: The device is a physical implant (humeral stem, adapters, locking screw, humeral heads) made of materials like titanium and cobalt-chromium. These are components designed to be surgically implanted.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such testing.
The information provided clearly describes a surgically implanted medical device, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Catalyst EA Convertible Stemmed Shoulder is intended for use as a replacement of shoulder joints in anatomic or reverse arthroplasty. Should the need arise for a conversion from an anatomic total shoulder, the humeral stem can remain in place, while the articulating surfaces are exchanged.
Anatomic Total Shoulder or Hemi-Shoulder
The Catalyst EA Convertible Stemmed Shoulder is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst EA Convertible Stemmed for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable.
- · Osteoarthritis
- · Avascular Necrosis
- · Rheumatoid Arthritis
- · Post-traumatic Arthritis
- · Correction of functional deformity
The Catalyst 3-Peg glenoid implants are intended for cemented use only.
The Catalyst R1 Reverse Shoulder humeral stems are intended for cemented or uncemented applications.
Reverse Total Shoulder
The Catalyst EA Convertible Stemmed 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 Catalyst R1 Shoulder humeral stems are intended for uncemented applications.
The glenoid baseplate is intended for uncemented use with the addition of screws for fixation.
Product codes (comma separated list FDA assigned to the subject device)
KWS, HSD, PHX
Device Description
The Catalyst EA Convertible Stemmed Shoulder is an anatomic designed total shoulder prosthesis that mates with the Catalyst R1 humeral stems cleared in K202611.
This submission adds conversion adapters, locking screw and humeral heads to mate with the previously cleared Catalyst R1 humeral stems. The humeral head components are compatible with previously cleared CSR 3 Peg glenoid components or for articulation with the glenoid cavity of the scapula. When the humeral stem (cleared K202611), adapter and humeral head are mated together, this creates a hemiarthroplasty (product code HSD). When the humeral stem, adapter and humeral head are used in conjunction with the CSR glenoid components (cleared K191811 and K173812), this creates a total shoulder arthroplasty (product code KWS). The adapters and locking screw are manufactured from Ti-6A1-4V ELI conforming to ASTM F136. The humeral components are manufactured from Co-Cr-Mo alloy conforming to ASTM F1537.
The Anatomic system consists of a humeral stem, adapter, locking screw and articulating head. The adapters are secured to the stem using a locking screw. The articulating humeral heads are secured to the adapter by a taper lock. The articulating head components have a polished surface for articulation with the compatible Catalyst 3-Peg Glenoid component or the glenoid cavity of the scapula.
The Reverse system consists of a humeral stem, articulating insert, central baseplate, fixation elements 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 4.5mm peripheral screws and either a central 6.5mm screw or post. The glenosphere is secured to the central baseplate by a taper lock, with the additional fixation of a locking or compression screw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint, glenohumeral joint, humeral head, glenoid vault, scapula, proximal humerus
Indicated Patient Age Range
skeletally mature individuals
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Range of motions analyses, biocompatibility assessment and construct fatigue testing were all conducted. Axial disassembly tests were performed pre-fatigue and post-fatigue testing. The construct fatigue testing demonstrated that the construct of the Catalyst EA Convertible Stemmed Shoulder humeral heads with conversion adapter, met the pre-determined acceptance criterion. All testing has determined that the device is substantially equivalent to the predicate device.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst EA Convertible Stemmed Shoulder to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Encore Medical (DJO) AltiVate Shoulder System K172351, Catalyst CSR Shoulder System, K182500
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
November 10, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image, there is the Department of Health & Human Services logo. To the right of that, there is a blue square with the letters "FDA" in white. To the right of the blue square, there is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Catalyst OrthoScience, Inc. Dale Davison Senior VP - Product Development 14710 Tamiami Trail North Naples, Florida 34110
Re: K222317
Trade/Device Name: Catalyst EA Convertible Stemmed Shoulder Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD, PHX Dated: September 23, 2022 Received: September 23, 2022
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by Farzana Farzana Sharmin -S Sharmin -S Date: 2022.11.10
For Victoria Lilling, M.D. 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) K222317
Device Name
Catalyst EA Convertible Stemmed Shoulder
Indications for Use (Describe)
The Catalyst EA Convertible Stemmed Shoulder is intended for use as a replacement of shoulder joints in anatomic or reverse arthroplasty. Should the need arise for a conversion from an anatomic total shoulder, the humeral stem can remain in place, while the articulating surfaces are exchanged.
Anatomic Total Shoulder or Hemi-Shoulder
The Catalyst EA Convertible Stemmed Shoulder is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst EA Convertible Stemmed for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable.
- · Osteoarthritis
- · Avascular Necrosis
- · Rheumatoid Arthritis
- · Post-traumatic Arthritis
- · Correction of functional deformity
The Catalyst 3-Peg glenoid implants are intended for cemented use only.
The Catalyst R1 Reverse Shoulder humeral stems are intended for cemented or uncemented applications.
Reverse Total Shoulder
The Catalyst EA Convertible Stemmed 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 Catalyst R1 Shoulder humeral stems are intended for 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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."
4
| 510(k) Summary | |
|---|---|
| Prepared Date: | November 10, 2022 |
| Submitter: | Catalyst OrthoScience, Inc. |
| 14710 Tamiami Trail North, Suite 102 | |
| Naples, FL 34110 | |
| Contact: | Dale Davison |
| Sr. VP of Manufacturing & Product Development | |
| 1-239-325-9976 ext. 102 | |
| ddavison@catalystortho.com | |
| Proprietary Name: | Catalyst EA Convertible Stemmed Shoulder |
| Common Name: | Shoulder Prosthesis |
| Classification Name: | 21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained |
| cemented prosthesis; Class II | |
| 21 CFR 888.3690: Shoulder joint humeral (hemi-shoulder) | |
| metallic uncemented prosthesis; Class II | |
| Product Code: | KWS, HSD, PHX |
| Primary Predicate: | Encore Medical (DJO) AltiVate Shoulder System K172351 |
| Secondary Predicate: | Catalyst CSR Shoulder System, K182500 |
Device Description:
The Catalyst EA Convertible Stemmed Shoulder is an anatomic designed total shoulder prosthesis that mates with the Catalyst R1 humeral stems cleared in K202611.
This submission adds conversion adapters, locking screw and humeral heads to mate with the previously cleared Catalyst R1 humeral stems. The humeral head components are compatible with previously cleared CSR 3 Peg glenoid components or for articulation with the glenoid cavity of the scapula. When the humeral stem (cleared K202611), adapter and humeral head are mated together, this creates a hemiarthroplasty (product code HSD). When the humeral stem, adapter and humeral head are used in conjunction with the CSR glenoid components (cleared K191811 and K173812), this creates a total shoulder arthroplasty (product code KWS). The adapters and locking screw are manufactured from Ti-6A1-4V ELI conforming to ASTM F136. The humeral components are manufactured from Co-Cr-Mo alloy conforming to ASTM F1537.
5
The Anatomic system consists of a humeral stem, adapter, locking screw and articulating head. The adapters are secured to the stem using a locking screw. The articulating humeral heads are secured to the adapter by a taper lock. The articulating head components have a polished surface for articulation with the compatible Catalyst 3-Peg Glenoid component or the glenoid cavity of the scapula.
The Reverse system consists of a humeral stem, articulating insert, central baseplate, fixation elements 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 4.5mm peripheral screws and either a central 6.5mm screw or post. The glenosphere is secured to the central baseplate by a taper lock, with the additional fixation of a locking or compression screw.
Intended Use / Indications:
The Catalyst EA Convertible Stemmed Shoulder is intended for use as a replacement of shoulder joints in anatomic or reverse arthroplasty. Should the need arise for a conversion from an anatomic total shoulder to a reverse total shoulder, the humeral stem can remain in place, while the articulating surfaces are exchanged.
Anatomic Total Shoulder or Hemi-Shoulder
The Catalyst EA Convertible Stemmed Shoulder is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst EA Shoulder System is intended for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable.
- Osteoarthritis
- Avascular Necrosis ●
- Rheumatoid Arthritis
- Post-traumatic Arthritis
- Correction of functional deformity ●
The Catalyst 3-Peg glenoid implants are intended for cemented use only.
The Catalyst R1 Shoulder humeral stems are intended for uncemented applications.
Reverse Total Shoulder
The Catalyst EA Convertible Stemmed Shoulder 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; ●
- o 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 o the natural humeral head and/or glenoid;
- Inflammatory arthritis including rheumatoid arthritis; ●
- Correction of functional deformity
6
The Catalyst R1 Shoulder humeral stems are intended for uncemented applications. The glenoid baseplate is intended for uncemented use with the addition of screws for fixation.
Comparison of Technologies/Substantial Equivalence:
The Catalyst EA Convertible Stemmed Shoulder is substantially equivalent to the predicate devices in regard 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.
Non-Clinical Testing:
Range of motions analyses, biocompatibility assessment and construct fatigue testing were all conducted. Axial disassembly tests were performed pre-fatigue and post-fatigue testing. The construct fatigue testing demonstrated that the construct of the Catalyst EA Convertible Stemmed Shoulder humeral heads with conversion adapter, met the pre-determined acceptance criterion. All testing has determined that the device is substantially equivalent to the predicate device.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst EA Convertible Stemmed Shoulder to the predicate devices.
Conclusions:
The conclusions drawn from the nonclinical and clinical 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.