SELECT SHOULDER COCR HUMERAL STEM COMPONENT

K962315 · Intermedics Orthopedics · KWT · Sep 3, 1996 · Orthopedic

Device Facts

• Record ID: K962315
• Device Name: SELECT SHOULDER COCR HUMERAL STEM COMPONENT
• Applicant: Intermedics Orthopedics
• Product Code: KWT · Orthopedic
• Decision Date: Sep 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Select Shoulder Humeral Stem is a metallic humeral component manufactured from cobalt chrome alloy (CoCrMo) and is intended for use with bone cement in total shoulder arthroplasty.

Device Story

Metallic humeral component; cobalt chrome alloy (CoCrMo); intended for cemented total shoulder arthroplasty. Features: proximal trapezoidal taper, grit-blasted surface for cement fixation, antirotation fin, suture holes for soft tissue/bony fragment attachment, distal fluted tip for rotational stability, Morse-type taper for humeral head attachment. Used by orthopedic surgeons in clinical/OR settings. Provides stable cement mantle; facilitates glenohumeral joint reconstruction; enables soft tissue repair. Device survives physiologic loading per fatigue/taper testing.

Clinical Evidence

Bench testing only. Fatigue analysis and taper testing performed to verify structural integrity under physiologic loading conditions.

Technological Characteristics

Material: Cobalt chrome alloy (CoCrMo). Design: Proximally grit-blasted, trapezoidal taper, antirotation fin, distal fluted tip. Connection: Morse-type taper for humeral head attachment. Fixation: Cemented. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring total shoulder arthroplasty, including proximal fractures, where a cemented humeral component is required for joint reconstruction.

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.”

Reference Devices

• Depuy Global Total Shoulder System
• Biomet Bio-Modular Total Shoulder
• Zimmer Fenlin Total Shoulder
• Kirschner Integrated Shoulder System
• 3M/Orthomet Neer II Shoulder System
• Smith & Nephew Richards Cofield Shoulder

Submission Summary (Full Text)

{0}

SEP 3 1996

K962315

# 510(k) SUMMARY

June 6, 1996

In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a 510(k) Summary for the Intermedics Orthopedics, Inc. Select® Shoulder System CoCr Humeral Stem.

Submitter: Intermedics Orthopedics, Inc.
9900 Spectrum Drive
Austin, TX 78717
[phone]

Contact Person: Jacquelyn Hughes
Manager, Regulatory Affairs

Classification Name: Shoulder joint metal/polymer non-constrained cemented prosthesis - 21 CFR Part 888.3650
Shoulder joint metal/polymer semi-constrained cemented prosthesis - 21 CFR Part 888.3660

Common/Usual Name: Humeral Stem

Trade/Proprietary: Select® Shoulder CoCr Humeral Stem

# Product Description/Substantial Equivalence:

The Select Shoulder Humeral Stem is a metallic humeral component manufactured from cobalt chrome alloy (CoCrMo) and is intended for use with bone cement in total shoulder arthroplasty. The humeral stem is available in a variety of sizes and lengths and features a proximally grit blasted surface (except for the head stem taper) for enhanced cement fixation. The proximal trapezoidal shape tapers in the A-P plane, thus providing for a stable cement mantle. The proximal body also features an antirotation fin on the lateral aspect. Suture holes are provided in the medial proximal body and lateral fin to allow for soft tissue/bony fragment attachment and tensioning, thus resulting in a more biomechanically stable construct for repair for proximal fractures. A male IOI Morse type taper permits attachment of one of the metallic humeral heads offered by Intermedics Orthopedics. This taper is identical to the taper of the previously cleared Select Shoulder System. Distally, the stem is rounded and fluted to provide enhanced fixation and rotational stability. The distal stem tip is designed to accept a cement centralizer. The humeral stem is designed for use with Intermedics Orthopedics humeral heads and glenoid components in a variety of sizes and heights for increased stability of the glenohumeral joint.

Fatigue analysis and taper testing of the Select Shoulder Humeral Stem indicated that the device would survive physiologic loading.

The Select Shoulder CoCr Humeral Stem is similar to those of the Depuy Global Total Shoulder System, the Biomet Bio-Modular Total Shoulder, the Zimmer Fenlin Total Shoulder, the Kirschner Integrated Shoulder System, the 3M/Orthomet Neer II Shoulder System, and the Smith

000336

{1}

& Nephew Richards Cofield Shoulder.

000337