SELECT SHOULDER KEELED ALL-POLY GLENOIDS
Device Facts
| Record ID | K962238 |
|---|---|
| Device Name | SELECT SHOULDER KEELED ALL-POLY GLENOIDS |
| Applicant | Intermedics Orthopedics |
| Product Code | KWT · Orthopedic |
| Decision Date | Aug 9, 1996 |
| Decision | SN |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3650 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Keeled All-Poly (ASTM F648) Glenoids are one piece designs intended to reproduce the function of the natural glenoid. The design of these glenoid components allows use in the right or left shoulder. The implant is cemented into the subchondral bone of the glenoid cavity providing a cement mantle of approximately 1-2 mm.
Device Story
One-piece glenoid prosthesis; replaces natural glenoid function; implanted via cementation into subchondral bone; features curved back with medial keel for stability; includes circumferential groove for intraoperative trimming; concave lateral surface accommodates humeral head; dovetail cement grooves enhance fixation; titanium x-ray marker pins included for postoperative evaluation; used by orthopedic surgeons in clinical settings; provides translational/rotational stability; facilitates shoulder joint reconstruction.
Clinical Evidence
Bench testing only. Contact area testing performed to evaluate performance at various levels of abduction, confirming adequate contact area.
Technological Characteristics
Material: Ultra-high molecular weight polyethylene (ASTM F648). Features: Medial keel, circumferential trimming groove, dovetail cement grooves, titanium x-ray marker pins. Fixation: Cemented. Design: Non-constrained and congruent options.
Indications for Use
Indicated for patients requiring shoulder joint replacement using a metal/polymer non-constrained or semi-constrained cemented prosthesis.
Regulatory Classification
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).
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 “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.”
Predicate Devices
- Orthomet/3M Modular Neer II Shoulder System
- Zimmer Fenlin Total Shoulder
- Smith & Nephew Richards Cofield Shoulder
- Kirschner/Biomet Modular Shoulder
- Biomet Bio-Modular Total Shoulder
- Depuy Global Total Shoulder System
Related Devices
- K962244 — SELECT SHOULDER PEGGED ALL-POLY GLENOID · Intermedics Orthopedics · Aug 9, 1996
- K970567 — SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS · Intermedics Orthopedics · Feb 27, 1997
- K103104 — SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT · Howmedica Osteonics Corp. · Nov 22, 2010
- K962082 — OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT · Osteonics Corp. · Aug 13, 1996
- K990136 — ANATOMICA GLENOID COMPONENT · Sulzer Orthopedics, Inc. · Mar 1, 1999
