(156 days)
The Catalyst R1 Reverse 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:
- · Bone defect in proximal humerus;
- 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 humeral stems are intended for cemented or uncemented applications.
The glenoid baseplate is intended for uncemented use with the addition of screws for fixation.
The Catalyst R1 Reverse Shoulder System is a total shoulder prosthesis designed for use in patients with a non-functional rotator cuff. The articulation of this reverse design is inverted compared to a traditional anatomic total shoulder prosthesis, where the articulating sphere is on the glenoid side of the joint, and the mating insert is fixed into the humeral stem implant.
The humeral implant system consists of humeral stems and polyethylene inserts. The stem implants are manufactured from Ti-6Al-4V ELI conforming to ASTM F136 with a porous structure on the proximal portion. The humeral stems are offered in short and long stem configurations to accommodate varying bone geometries. The humeral articulating inserts are manufactured from UHMWPE conforming to ASTM F648. They have a concave bearing geometry that radially matches the different sized glenospheres and are offered in varying thicknesses to achieve stability of the glenohumeral joint.
The glenoid implant system consists of a central baseplate, glenosphere, fixation components, and locking components. The central baseplate is a circular disc that rests against the glenoid bone and is secured to the bone using up to four peripheral screws and either a central screw or post. The baseplate is manufactured from Ti-6AI-4V ELI conforming to ASTM F136 with a titanium plasma spray on the bone facing surface. The baseplate is offered in standard and augmented configurations. The Co-Cr-Mo glenospheres are manufactured from CoCrMo conforming to ASTM F1537 and are secured to the baseplate by a taper lock, and with an additional locking screw. The fixation components are manufactured from Ti-6Al-4V ELI conforming to ASTM F136.
The provided text describes a medical device submission (K202611) for the Catalyst OrthoScience R1 Reverse Shoulder System. It is a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria through extensive clinical studies.
Therefore, the document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst R1 Reverse Shoulder System to the predicate devices."
This means that a study proving the device meets acceptance criteria as typically understood for new major medical devices (e.g., in terms of clinical outcomes, diagnostic performance, or comparative effectiveness with human readers for AI) was not performed or required for this 510(k) clearance.
Instead, the acceptance criteria for this device are based on demonstrating equivalence to already legally marketed predicate devices through:
- Mechanical and materials testing: Ensuring the device meets relevant ASTM and ISO standards for its intended use.
- Design and intended use similarity: Showing that the new device's design, materials, indications for use, and size ranges are comparable to predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission focused on substantial equivalence and not a de novo clinical trial, the "acceptance criteria" are the demonstration of similarity to predicate devices and performance in non-clinical testing.
| Acceptance Criteria (Demonstrated Equivalence/Performance of Non-Clinical Testing) | Reported Device Performance |
|---|---|
| Substantial Equivalence: | |
| Intended Use and Indications | The Catalyst R1 Reverse Shoulder System's intended use and indications for use are substantially equivalent to the predicate devices (Encore Medical (DJO) Altivate Reverse Shoulder System, FX Solutions Humelock Reversed Shoulder, Arthrex Univers Revers Modular Glenoid). Indications include severe arthropathy, failed joint replacement, fracture, bone defect, non-inflammatory degenerative disease, inflammatory arthritis, and correction of functional deformity, all with a grossly deficient rotator cuff and functional deltoid muscle. |
| Materials | The device uses the same materials as predicate devices: Ti-6Al-4V ELI (humeral stems, baseplate, fixation components), UHMWPE (humeral articulating inserts), and CoCrMo (glenospheres). Conforms to ASTM F136, ASTM F648, and ASTM F1537 respectively. |
| Size Ranges | Same size ranges as predicate devices. |
| Design Intent | Same design intent as predicate devices (inverted articulation for reverse total shoulder replacement). |
| Non-Clinical Performance: | |
| Range of motion analyses | Completed. Results indicate adequate performance for intended use. |
| Complete construct fatigue testing (per ASTM F1378) | Completed. Results indicate adequate performance for intended use. |
| Post-fatigue disassembly testing | Completed. Results indicate adequate performance for intended use. |
| Testing of glenoid stability (per ASTM F2028) | Completed. Results indicate adequate performance for intended use. |
| Chemical characterization (per ISO 10993 Part 18) | Conducted on implant materials. |
| Cytotoxicity testing | Conducted on implant materials. |
| Pyrogenicity testing | Conducted on implant materials. Met the recommended limit of |
§ 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.”