(121 days)
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.
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 Press-Fit Humeral Components to the CSR Shoulder System. The press-fit humeral components 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 Press-Fit Humeral Components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The undersurface of the head and the proximal portion of the alignment pegs are coated with a plasma sprayed coating of CP Ti conforming to ASTM F1580.
The CSR humeral components are compatible with previously cleared CSR 3 Peg glenoid components.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Catalyst CSR Press-Fit Humeral Components:
Summary of Device and Context:
The document is an FDA 510(k) clearance letter and a 510(k) Summary for the Catalyst CSR Press-Fit Humeral Components, which are an addition to the existing Catalyst CSR Shoulder System. This device is a shoulder prosthesis intended for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint, where the humeral head, neck, and glenoid vault have sufficient bone stock, and the rotator cuff is intact or reconstructable. The key new feature here is the "Press-Fit" capability, allowing for uncemented or cemented use, and the device incorporates a plasma sprayed coating of CP Ti. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
Detailed Analysis of Acceptance Criteria and Study Information:
Based on the provided text, the focus is on non-clinical testing to demonstrate substantial equivalence, as clinical testing was deemed unnecessary.
- Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fixation strength in shear | Met the pre-determined acceptance criterion through Static Shear Testing. |
| Endotoxin limit (Bacterial Endotoxin Testing) | Met the acceptable 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.”