(101 days)
Not Found
No
The device description and performance studies focus solely on the mechanical components and biocompatibility of a shoulder replacement system, with no mention of AI or ML technologies.
Yes
The device is a total shoulder replacement system intended to alleviate pain and dysfunction due to severe arthropathy, failed joint replacements, fractures, degenerative diseases, and inflammatory arthritis. These indications are characteristic of a therapeutic medical device.
No
The provided text describes the Catalyst F1x Shoulder System as a "reverse total shoulder replacement," which is a prosthetic device for reconstructive surgery. Its intended use is to replace damaged shoulder joints, not to diagnose a condition.
No
The device description clearly outlines physical components such as proximal bodies, distal stems, locking screws, and spacers, which are hardware implants for shoulder replacement surgery.
Based on the provided information, the Catalyst F1x Shoulder System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Catalyst F1x Shoulder System is a surgical implant intended to replace a damaged shoulder joint. It is a physical device implanted into the body, not a tool for analyzing biological samples.
The description clearly outlines its use as a reverse total shoulder replacement for patients with specific shoulder conditions. This falls under the category of a medical device, specifically a prosthetic implant, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Catalyst F1x 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;
• 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 F1x press-fit stems are intended for cementless press-fit applications.
The Catalyst F1x cemented stems are intended for cemented fixation.
The Catalyst F1x stem is compatible with the implants from the R1 Shoulder Systems.
Product codes (comma separated list FDA assigned to the subject device)
PHX
Device Description
The Catalyst F1x Shoulder System is intended for use as a replacement of shoulder joints in reverse arthroplasty. The stems can be used in conjunction with the Catalyst R1 Reverse Shoulder humeral articulating poly inserts and glenoid implants for use in reverse shoulder arthroplasty.
This submission for the Catalyst F1x Shoulder System consists of proximal bodies, distal stems, locking screws and spacers. The fracture specific proximal bodies have asymmetric, right- and left-sided finned geometry to provide specific locations to reattach the greater and lesser tuberosities for a stable reconstruction of the proximal humerus. The proximal bodies have a porous titanium structure on the bone engaging regions. The distal stems shall be provided in varying diameters to accommodate varying bone geometries. The distal stems will be offered in press-fit and cemented versions. The press-fit distal stems shall have a tapered, splined proximal geometry with an HA (hydroxyapatite) coating. The cemented stems shall have a smooth stem geometry. The proximal bodies and distal stems shall be secured together using a mechanical taper interface that is supplemented with a locking screw. Spacers shall be provided to offer additional options for restoring the appropriate humeral height.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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: Biocompatibility assessment, construct fatigue testing, post-fatigue axial disassembly, post fatigue torsional disassembly, locking screw torque and corrosion evaluation tests were all conducted. 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 F1x Shoulder System 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.
K161189, K213349, K232583, K202611
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.
Not Found
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
April 5, 2024
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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the full name. The full name of the agency is "U.S. Food & Drug Administration".
Catalyst OrthoScience, Inc. Dale Davison Sr. VP - Product Development 14710 Tamiami Trail, North Ste. 102 Naples, Florida 34110
Re: K234105
Trade/Device Name: Catalyst F1x 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 Dated: March 5, 2024 Received: March 7, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Digitally signed by Farzana Farzana Sharmin -S Sharmin -S Date: 2024.04.05 14:27:49 -04'00'
Farzana Sharmin, PhD 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
2
Indications for Use
510(k) Number (if known) K234105
Device Name
Catalyst F1x Shoulder System
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
The Catalyst F x 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;
• 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 F1x press-fit stems are intended for cementless press-fit applications.
The Catalyst F1x cemented stems are intended for cemented fixation.
The Catalyst F1x stem is compatible with the implants from the R1 Shoulder Systems.
| 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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3
| 510(k) Summary | |
|---|---|
| Prepared Date: | April 4, 2024 |
| 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 F1x Shoulder System |
| Common Name: | Shoulder Prosthesis |
| Classification Name: | 21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained |
| cemented prosthesis; Class II | |
| Product Code: | PHX |
| Primary Predicate: | Integra Titan Reverse Shoulder System (K161189) |
| Additional Predicate: | Catalyst R1 Shoulder System (K213349, K232583 and K202611) |
Device Description:
The Catalyst F1x Shoulder System is intended for use as a replacement of shoulder joints in reverse arthroplasty. The stems can be used in conjunction with the Catalyst R1 Reverse Shoulder humeral articulating poly inserts and glenoid implants for use in reverse shoulder arthroplasty.
This submission for the Catalyst F1x Shoulder System consists of proximal bodies, distal stems, locking screws and spacers. The fracture specific proximal bodies have asymmetric, right- and left-sided finned geometry to provide specific locations to reattach the greater and lesser tuberosities for a stable reconstruction of the proximal humerus. The proximal bodies have a porous titanium structure on the bone engaging regions. The distal stems shall be provided in varying diameters to accommodate varying bone geometries. The distal stems will be offered in press-fit and cemented versions. The press-fit distal stems shall have a tapered, splined proximal geometry with an HA (hydroxyapatite) coating. The cemented stems shall have a smooth stem geometry. The proximal bodies and distal stems shall be secured together using a mechanical taper interface that is supplemented with a locking screw. Spacers shall be provided to offer additional options for restoring the appropriate humeral height.
4
Indications for Use
The Catalyst F1x 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;
- · 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 Catalyst F1x press-fit stems are intended for cementless press-fit applications. The Catalyst F1x cemented stems are intended for cemented fixation. The Catalyst F1x stem is compatible with the implants from the R1 Shoulder Systems.
Summary of Technologies/Substantial Equivalence:
The Catalyst F1x Shoulder System 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 different questions of safety and effectiveness, nor are there new technological issues.
Non-Clinical Testing:
Biocompatibility assessment, construct fatigue testing, post-fatigue axial disassembly, post fatigue torsional disassembly, locking screw torque and corrosion evaluation tests were all conducted. 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 F1x Shoulder System to the predicate devices.
Conclusions:
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, as the legally marketed predicate identified in this 510(k) Summary.