(57 days)
No
The document describes a mechanical shoulder prosthesis and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The "Intended Use / Indications for Use" section states that the device 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," aiming to treat conditions like osteoarthritis and avascular necrosis. These are therapeutic applications.
No
This device is a surgical implant (total shoulder prosthesis) used for treatment of degenerative diseases of the glenohumeral joint, not for diagnosing conditions.
No
The device description clearly details physical components made of Co-Cr-Mo alloy, indicating it is a hardware medical device, not software-only.
Based on the provided text, the Catalyst CSR 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 description of the Catalyst CSR Shoulder System clearly indicates it is a surgical implant designed to replace parts of the shoulder joint.
- The intended use and device description focus on surgical treatment of degenerative joint diseases. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- The performance studies described are non-clinical mechanical tests, not studies involving the analysis of biological specimens.
Therefore, the Catalyst CSR Shoulder System falls under the category of a medical device, specifically a prosthetic implant, rather than an IVD.
N/A
Intended Use / Indications for Use
The Catalyst CSR Shoulder System 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 CSR 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
Both components of the Catalyst CSR Shoulder System are intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
KWT, HSD
Device Description
The Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients where the humeral head, neck and glenoid vault are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed.
This submission adds larger, standard (non-spherical) humeral components to the CSR Shoulder System. Like the previously cleared CSR humeral components, the Size H and Size I CSR standard humeral components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. They have a non-spherical polished surface for articulation with the glenoid component or the glenoid cavity of the scapula. The humeral components incorporate 4 pegs which assist with alignment and provide rotational stability. The four plane geometry of the back side of the humeral component matches four cut surfaces on the humeral head to recreate the geometry and thickness of the removed bone.
The CSR humeral components are compatible with previously cleared CSR 3 Peg glenoid components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint, humeral head, neck, glenoid vault, scapula
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:
Static lever-out testing, endotoxin testing, size comparison and radial mismatch comparisons were performed on worst case CSR humeral components. The results indicate that the performance of the Catalyst CSR humeral components is adequate for their intended use.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the new Catalyst CSR humeral components 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.
Catalyst OrthoScience CSR Shoulder System (K152825)
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.
Biomet Versa-Dial Humeral Head Prosthesis (K060716), Zimmer Anatomical Shoulder Humeral Head and Anatomical Shoulder Keeled Glenoid (K053274, K051623), Tornier Aequalis PerFORM+ Shoulder System (K160975)
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
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
Image /page/0/Picture/0 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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Catalyst OrthoScience, Inc. Dale Davison Sr. VP of Manufacturing & Product Development 14710 Tamiami Trail North, Suite 102 Naples, Florida 34110
Re: K181287
Trade/Device Name: Catalyst CSR Shoulder System Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder Joint Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KWT, HSD Dated: June 11, 2018 Received: June 12, 2018
July 12, 2018
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K181287 Device Name Catalyst OrthoScience CSR Shoulder System
Indications for Use (Describe)
The Catalyst CSR Shoulder System 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 CSR 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
Both components of the Catalyst CSR Shoulder System are intended for cemented use only.
Type of Use (Select one or both, as applicable)
区Prescription Use (Part 21 CFR 801 Subpart D)
□Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form FDA 3881
3
| K181287
| 7 | |
|---|---|
| -------------- | -- |
| 510(k) Summary | |
|---|---|
| Prepared: | May 15, 2018 |
| Submitter: | Catalyst OrthoScience, Inc. |
| 14710 Tamiami Trail North, Suite 102 | |
| Naples, FL 34110 | |
| Contact: | Dale Davison |
| Sr. VP of Manufacturing & Product Development | |
| Catalyst OrthoScience, Inc. | |
| 1-239-325-9976 ext 102 | |
| ddavison@catalystortho.com | |
| Proprietary Name: | Catalyst CSR Shoulder System |
| Common Name: | Shoulder Prosthesis |
| Classification Names: | 21 CFR 888.3650: Shoulder joint metal/polymer non- |
| constrained cemented prosthesis; Class II |
21 CFR 888.3690: Shoulder joint humeral (hemi-shoulder)
metallic uncemented prosthesis; Class II |
| Product Codes: | KWT, HSD |
| Substantially
Equivalent Device: | • Catalyst OrthoScience CSR Shoulder System (K152825) |
| Reference Devices: | • Biomet Versa-Dial Humeral Head Prosthesis (K060716)
• Zimmer Anatomical Shoulder Humeral Head and
Anatomical Shoulder Keeled Glenoid
(K053274, K051623)
• Tornier Aequalis PerFORM+ Shoulder System
(K160975) |
Device Description:
The Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients where the humeral head, neck and glenoid vault are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed.
4
This submission adds larger, standard (non-spherical) humeral components to the CSR Shoulder System. Like the previously cleared CSR humeral components, the Size H and Size I CSR standard humeral components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. They have a non-spherical polished surface for articulation with the glenoid component or the glenoid cavity of the scapula. The humeral components incorporate 4 pegs which assist with alignment and provide rotational stability. The four plane geometry of the back side of the humeral component matches four cut surfaces on the humeral head to recreate the geometry and thickness of the removed bone.
The CSR humeral components are compatible with previously cleared CSR 3 Peg glenoid components.
Intended Use / Indications:
The Catalyst CSR Shoulder System 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 CSR 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
Both components of the Catalyst CSR Shoulder System are intended for cemented use only.
Summary of Technologies/Substantial Equivalence:
The additional Catalyst CSR humeral components are substantially equivalent to the predicate devices in regards to intended use and indications, material and design. The larger sizes do not raise new types of safety and effectiveness questions, nor are there new technological issues.
Non-Clinical Testing:
Static lever-out testing, endotoxin testing, size comparison and radial mismatch comparisons were performed on worst case CSR humeral components. The results indicate that the performance of the Catalyst CSR humeral components is adequate for their intended use.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the new Catalyst CSR humeral components to the predicate devices.