FOUNDATION GLENOID COMPONENT
Device Facts
| Record ID | K960906 |
|---|---|
| Device Name | FOUNDATION GLENOID COMPONENT |
| Applicant | Encore Orthopedics, Inc. |
| Product Code | KWS · Orthopedic |
| Decision Date | Apr 15, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3660 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
This total shoulder prosthesis is intended for treatment of patients who are candidates for total shoulder arthroplasty because the natural humeral head and/or glenoid has been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or proximal humeral fracture, and revision arthroplasty where bone loss is minimal. This system includes a humeral stem and head and is to be used with bone cement. These devices are intended to aid the surgeon in relieving the patient of shoulder pain and restoring shoulder motion.
Device Story
Glenoid component for total shoulder arthroplasty; fabricated from UHMWPE; features spherical back surface with keel or three-peg fixation; 4 mm thickness; five sizes available. Designed for cemented use with humeral stem and head. Mismatched radius of curvature between glenoid and humeral head allows for superior/inferior and anterior/posterior translation. Used by orthopedic surgeons in clinical settings to relieve shoulder pain and restore joint motion in patients with degenerative or traumatic shoulder conditions.
Clinical Evidence
Bench testing only.
Technological Characteristics
Material: UHMWPE (ASTM F648). Design: Semi-constrained, cemented, spherical back surface with keel or three-peg fixation. Dimensions: 4 mm thickness, five sizes. Energy source: None (mechanical).
Indications for Use
Indicated for patients requiring total shoulder arthroplasty due to osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, proximal humeral fracture, or revision arthroplasty with minimal bone loss.
Regulatory Classification
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).
Special Controls
*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.”
Predicate Devices
- Encore Foundation™ Total Shoulder System
- Kirshner Neer II™ Glenoid Component
- Intermedics Select™ Shoulder Glenoid Component
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