(225 days)
Not Found
No
The 510(k) summary describes a mechanical shoulder prosthesis and does not mention any software, algorithms, or AI/ML capabilities. The testing described is mechanical in nature.
Yes
The device is a total shoulder prosthesis used to treat degenerative diseases of the glenohumeral joint, aiming to alleviate symptoms and restore function.
No
The device is a shoulder prosthesis intended for surgical replacement in individuals with degenerative diseases of the glenohumeral joint. It is a treatment device, not one that gathers or analyzes data for diagnosis.
No
The device description clearly details physical components made of UHMWPE and Co-Cr-Mo alloy, indicating it is a hardware medical device.
Based on the provided information, the Catalyst CSR Shoulder System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Catalyst CSR Shoulder System Function: The Catalyst CSR Shoulder System is a surgical implant designed to replace damaged parts of the shoulder joint. It is a physical device implanted into the body to restore function.
- Intended Use: The intended use clearly states it's for treating degenerative diseases of the glenohumeral joint through surgical arthroplasty. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
- Device Description: The description details the materials and design of the implant components (humeral and glenoid components), not a system for analyzing biological samples.
Therefore, the Catalyst CSR Shoulder System falls under the category of a surgical implant or prosthetic device, 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
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.
The Catalyst CSR glenoid components are manufactured from UHMWPE conforming to ASTM F648. Three sizes of glenoid components are available, with right and left sides. 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. Two backside anchoring elements are engineered to match the shape of the glenoid vault and provide implant fixation within the dense cortical and subchondral bone. The triangular shape of the anchoring elements combines attributes of both peg and keel designs to resist loosening forces.
The Catalyst CSR humeral components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75 and have a polished surface for articulation with the glenoid component or the glenoid cavity of the scapula. The humeral components are designed with standard (non-spherical) and spherical geometries. The standard humeral components have seven sizes and the spherical humeral components have six sizes. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint, humeral head, 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:
Characterization of the UHMWPE, lever-out and torque-out testing of the glenoid components, dynamic shear testing of the glenoid components, lever-out testing and torqueout calculations of the humeral components, and testing of glenoid stability per ASTM F2028-14 were conducted. The results of these tests indicate that the performance of the Catalyst CSR Shoulder System is adequate for its intended use.
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.
K131298, K023096, K091196, K031971, K981487, K003044
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
§ 888.3650 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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 11, 2016
Catalyst Orthoscience LLC Mr. Stephen Herrington Chief Executive Officer 5867 Whisperwood Ct Naples, Florida 34110
Re: K152825
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: April 1, 2016 Received: April 6, 2016
Dear Mr. Herrington:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152825
Device Name Catalyst 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) | |
|---|---|
| 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: | April 1, 2016 |
| Submitter: | Catalyst OrthoScience LLC |
| 5867 Whisperwood Ct | |
| Naples, FL 34110 | |
| Contact: | Stephen Herrington |
| Chief Executive Officer, | |
| Catalyst OrthoScience LLC | |
| 1-800-587-5137 | |
| sherrington@catalystortho.com | |
| Proprietary Name: | Catalyst CSR Shoulder System |
| Common Name: | Resurfacing Total 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 Devices: | Exactech Equinoxe Resurfacing System (K131298) Arthrosurface HemiCAP System (K023096, K091196) DePuy Global C.A.P and Anchor Peg Glenoid (K031971, K981487) Biomet Copeland Resurfacing Heads (K003044) Tornier Aequalis PerFORM+ Shoulder System |
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
The Catalyst CSR glenoid components are manufactured from UHMWPE conforming to ASTM F648. Three sizes of glenoid components are available, with right and left sides. 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. Two backside anchoring elements are engineered to match the shape of the glenoid vault and provide implant fixation within the dense cortical and subchondral bone. The triangular shape of the anchoring elements combines attributes of both peg and keel designs to resist loosening forces.
The Catalyst CSR humeral components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75 and have a polished surface for articulation with the glenoid component or the glenoid cavity of the scapula. The humeral components are designed with standard (non-spherical) and spherical geometries. The standard humeral components have seven sizes and the spherical humeral components have six sizes. 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.
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.
5
Summary of Technologies/Substantial Equivalence:
The Catalyst CSR Shoulder System is substantially equivalent to the predicate devices in regards to intended use and indications, materials, size ranges, and design intent. Any noted differences do not raise new types of safety and effectiveness questions.
Non-Clinical Testing:
Characterization of the UHMWPE, lever-out and torque-out testing of the glenoid components, dynamic shear testing of the glenoid components, lever-out testing and torqueout calculations of the humeral components, and testing of glenoid stability per ASTM F2028-14 were conducted. The results of these tests indicate that the performance of the Catalyst CSR Shoulder System is adequate for its intended use.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst CSR Shoulder System to the predicate devices.