SELECT SHOULDER PEGGED ALL-POLY GLENOID
Device Facts
| Record ID | K962244 |
|---|---|
| Device Name | SELECT SHOULDER PEGGED ALL-POLY GLENOID |
| 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 Pegged All-Poly (ASTM F648) Glenoid is a one piece design intended to reproduce the function of the natural glenoid. The design of this glenoid component 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; non-constrained design. Features flat back, two grooved pegs for intraoperative trimming, and circumferential dovetail cement groove for stability/fixation. Concave lateral surface accommodates humeral head. Includes titanium pins for postoperative radiographic evaluation. Implanted via cementation into subchondral bone of glenoid cavity. Used by orthopedic surgeons in clinical/OR settings. Provides stable articulation for humeral head; restores shoulder joint function.
Clinical Evidence
Bench testing only. Contact area testing performed to evaluate performance at various levels of abduction, demonstrating adequate contact area.
Technological Characteristics
Material: ASTM F648 ultra-high molecular weight polyethylene. Features: two grooved pegs, circumferential dovetail cement groove, titanium pins for radiographic visualization. Non-constrained geometry. Cemented fixation.
Indications for Use
Indicated for patients requiring shoulder joint replacement using a non-constrained cemented prosthesis to reproduce natural glenoid function.
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
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- 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
- K990136 — ANATOMICA GLENOID COMPONENT · Sulzer Orthopedics, Inc. · Mar 1, 1999
- K052472 — DEPUY GLOBAL SHOULDER CROSSLINK GLENOID · DePuy Orthopaedics, Inc. · Oct 6, 2005
