(84 days)
No
The summary describes a mechanical shoulder prosthesis and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a total shoulder prosthesis used to treat degenerative diseases of the glenohumeral joint, which directly addresses a medical condition to restore function.
No
Explanation: The device described is a shoulder replacement system (prosthesis) used to treat degenerative diseases of the glenohumeral joint. It is an implantable device designed for treatment, not for diagnosing a condition.
No
The device description clearly states it is a bone preserving total shoulder prosthesis and describes physical components made of UHMWPE, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical implant used to treat degenerative diseases of the glenohumeral joint. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a bone-preserving total shoulder prosthesis, which is a physical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition. The device is used after a diagnosis has been made by a surgeon.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for treatment.
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
KWT
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 3 peg glenoids to the CSR Shoulder System. The Catalyst CSR 3 peg glenoid components are manufactured from UHMWPE conforming to ASTM F648. Three sizes of glenoid components are available. The bearing surface has a symmetrical, oval shaped profile allowing use of each component on either the right or the left side. The glenoid component is designed to allow insertion at an angle, in the same orientation as the surgeon's exposure, to reduce the forceful retraction and soft tissue trauma usually required to insert standard glenoid components. Three backside pegs are engineered to provide implant fixation within the dense cortical and subchondral bone. Two versions of the 3 peg glenoid are available with the pegs angled at either 17 or 25 degrees.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint
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
Non-Clinical Testing:
Static lever-out, static torque-out, dynamic shear testing of glenoid stability per ASTM F2028-14 were conducted on the Catalyst CSR 3 Peg Glenoid components. The results of these tests indicate that the performance of the Catalyst CSR Shoulder System is adequate for its intended use. Bacterial Endotoxin Testing was performed on the predicate Catalyst CSR Glenoid components and the endotoxin limit of 20EU/device was met. The Catalyst CSR 3 Peg Glenoids did not create a new worst case for endotoxin levels.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst CSR 3 Peg Glenoids to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Catalyst OrthoScience CSR Shoulder System, K152825, DePuy Anchor Peg Glenoid, K981487, Tornier Aequalis PerFORM+ Shoulder System, K150583
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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Image /page/0/Picture/0 description: The image contains 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Catalyst OrthoScience, Inc Dale Davison Sr. VP of Manufacturing & Product Development 14710 Tamiami Trail North, Suite 102 Naples, Florida 34110
March 9, 2018
Re: K173812
Trade/Device Name: Catalyst CSR 3 Peg Glenoids Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWT Dated: December 12, 2017 Received: December 15, 2017
Dear Mr. 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.
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/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
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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)
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)
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| 510(k) Summary | |
|---|---|
| Prepared: | December 12, 2017 |
| 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 3 Peg Glenoids |
| Common Name: | Shoulder Prosthesis |
| Classification Names: | 21 CFR 888.3650: Shoulder joint metal/polymer non- |
| constrained cemented prosthesis; Class II | |
| Product Code: | KWT |
| Substantially Equivalent | |
| Devices | • Catalyst OrthoScience CSR Shoulder System, K152825 |
| • DePuy Anchor Peg Glenoid, K981487 | |
| • Tornier Aequalis PerFORM+ Shoulder System, K150583 |
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 3 peg glenoids to the CSR Shoulder System. The Catalyst CSR 3 peg glenoid components are manufactured from UHMWPE conforming to ASTM F648. Three sizes of glenoid components are available. The bearing surface has a symmetrical, oval shaped profile allowing use of each component on either the right or the left side. The glenoid component is designed to allow insertion at an angle, in the same orientation as the surgeon's exposure, to reduce the forceful retraction and soft tissue trauma usually required to insert standard glenoid components. Three backside pegs are engineered to
4
provide implant fixation within the dense cortical and subchondral bone. Two versions of the 3 peg glenoid are available with the pegs angled at either 17 or 25 degrees.
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 Catalyst CSR 3 Peg Glenoids are substantially equivalent to the predicate devices in regards to intended use and indications, material, 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:
Static lever-out, static torque-out, dynamic shear testing of glenoid stability per ASTM F2028-14 were conducted on the Catalyst CSR 3 Peg Glenoid components. The results of these tests indicate that the performance of the Catalyst CSR Shoulder System is adequate for its intended use. Bacterial Endotoxin Testing was performed on the predicate Catalyst CSR Glenoid components and the endotoxin limit of 20EU/device was met. The Catalyst CSR 3 Peg Glenoids did not create a new worst case for endotoxin levels.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst CSR 3 Peg Glenoids to the predicate devices.