(68 days)
Not Found
No
The document describes a physical medical device (shoulder prosthesis) and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a total shoulder prosthesis used to treat degenerative diseases of the glenohumeral joint, which directly addresses and alleviates a medical condition.
No
The device is a total shoulder prosthesis, which is an implant used in surgery to replace parts of the shoulder joint, not a device used to diagnose a medical condition.
No
The device description clearly describes physical implants (humeral and glenoid components) made of UHMWPE, which are hardware components, not software.
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 for treating degenerative diseases of the glenohumeral joint. It is used in the body, not on or with samples taken from the body for diagnostic purposes.
- Device Description: The description details a bone preserving total shoulder prosthesis, including humeral and glenoid implants. This is a physical implant, not a diagnostic test or reagent.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information. The device's function is mechanical replacement of a joint.
Therefore, the Catalyst CSR Shoulder System falls under the category of a surgical implant, not an In Vitro Diagnostic device.
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
The Catalyst CSR humeral and glenoid implants are intended for cemented use.
The Catalyst CSR Press-Fit humeral implants are intended for uncemented or cemented use.
Product codes (comma separated list FDA assigned to the subject device)
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 augmented glenoid components to the CSR Shoulder System. The CSR Augmented Glenoids are nearly identical to the previously cleared CSR 3 Peg Glenoids, except that additional material has been added to the fixation surface creating a 10 degree posterior wedge. Like the previously cleared CSR 3 Peg glenoid components, the CSR Augments are manufactured from UHMWPE conforming to ASTM F648. Also like the previously cleared CSR 3 Peg Glenoid components, three sizes of augmented 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 bone 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.
The CSR Augmented Glenoid components are compatible with previously cleared CSR Press-Fit humeral components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint, shoulder
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:
The CSR Augmented Glenoids were tested for glenoid stability per ASTM F2028-14 with results demonstrating that their performance is adequate for their intended use. Bacterial Endotoxin Testing was performed using the Limulus Amebocyte Lysate (LAL) test on worst case components. Results demonstrate that the CSR Augmented Glenoids meet an endotoxin limit of
§ 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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
September 11, 2019
Catalyst OrthoScience, Inc. Dale Davison Sr. VP of Manufacturing & Product Development 14710 Tamiami Trail North, Suite 102 NAPLES FL 34110
Re: K191811
Trade/Device Name: Catalyst OrthoScience 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 Dated: August 9, 2019 Received: August 12, 2019
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
1
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 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 (OS) 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 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,
for
Michael Owens 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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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) K191811
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
The Catalyst CSR humeral and glenoid implants are intended for cemented use.
The Catalyst CSR Press-Fit humeral implants are intended for uncemented or cemented use.
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: | July 1, 2019 |
| 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 OrthoScience CSR Shoulder System |
| Common Name: | Shoulder Prosthesis |
| Classification Names: | 21 CFR 888.3650: Shoulder joint metal/polymer non-constrained |
| cemented prosthesis; Class II | |
| Product Codes: | KWT |
| Substantially | |
| Equivalent Devices: | • Catalyst OrthoScience CSR 3 Peg Glenoids, K173812 |
| • Exactech® Equinoxe® UHMWPE 16° Posterior Augment Pegged | |
| Glenoids, K121220 | |
| • DePuy Anchor Peg Glenoid, K981487 |
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 augmented glenoid components to the CSR Shoulder System. The CSR Augmented Glenoids are nearly identical to the previously cleared CSR 3 Peg Glenoids, except that additional material has been added to the fixation surface creating a 10 degree posterior wedge. Like the previously cleared CSR 3 Peg glenoid components, the CSR Augments are manufactured from UHMWPE conforming to ASTM F648. Also like the previously cleared CSR 3 Peg Glenoid components, three sizes of augmented 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 bone and soft tissue trauma usually required to insert standard glenoid components.
4
Three backside pegs are engineered to provide implant fixation within the dense cortical and subchondral bone.
The CSR Augmented Glenoid components are compatible with previously cleared CSR Press-Fit humeral 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
The Catalyst CSR humeral and glenoid implants are intended for cemented use.
The Catalyst CSR Press-Fit humeral implants are intended for uncemented or cemented use.
Summary of Technologies/Substantial Equivalence:
The Catalyst CSR Augmented Glenoid components are substantially equivalent to the predicate CSR 3 Peg Glenoid components in regards to intended use and indications, material and design. The addition of posterior augments does not raise different questions of safety and effectiveness.
Non-Clinical Testing:
The CSR Augmented Glenoids were tested for glenoid stability per ASTM F2028-14 with results demonstrating that their performance is adequate for their intended use. Bacterial Endotoxin Testing was performed using the Limulus Amebocyte Lysate (LAL) test on worst case components. Results demonstrate that the CSR Augmented Glenoids meet an endotoxin limit of