COCR BI-ANGULAR HUMERAL COMPONENT
Device Facts
| Record ID | K961571 |
|---|---|
| Device Name | COCR BI-ANGULAR HUMERAL COMPONENT |
| Applicant | Biomet, Inc. |
| Product Code | KWT · Orthopedic |
| Decision Date | Aug 5, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3650 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Device Story
CoCr Bi-Angular Humeral Component is a non-constrained metal humeral stem for shoulder arthroplasty. Device features tapered collarless geometry to load cement mantle in compression; proximal fins for rotational stability; suture holes for fracture reconstruction. Surface is grit-blasted (200 microinches) to enhance stem/cement fixation. Available in 7 primary sizes (6.5mm-15.5mm diameter, 115mm length) and revision sizes (8.0mm-14.0mm diameter, 190mm length). Intended for use with commercially available glenoid components. Implanted by orthopedic surgeons in clinical settings to restore joint function and stability in patients with humeral pathology.
Clinical Evidence
No clinical data provided. Safety and effectiveness are supported by design equivalence to predicate devices and literature citations regarding common complications associated with total shoulder arthroplasty.
Technological Characteristics
Material: Cobalt-Chromium (CoCr) alloy. Design: Tapered collarless humeral stem with proximal fins and suture holes. Surface treatment: Grit-blasted (200 microinches). Fixation: Cemented. Dimensions: 7 primary sizes (6.5-15.5mm diameter, 115mm length) and revision sizes (8.0-14.0mm diameter, 190mm length).
Indications for Use
Indicated for patients requiring shoulder joint replacement, including primary and revision cases, for conditions such as complex humeral fractures or other pathologies necessitating a non-constrained metal/polymer 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
- Atlas Shoulder (K940537)
- Neer Shoulder (K873073)
- Bi-Angular Shoulder (K872454)
Related Devices
- K962289 — SELECT SHOULDER COCR HUMERAL STEM COMPONENT · Intermedics Orthopedics · Aug 29, 1996
- K962315 — SELECT SHOULDER COCR HUMERAL STEM COMPONENT · Intermedics Orthopedics · Sep 3, 1996
- K032507 — INTERLOK BIO-MODULAR HUMERAL STEMS · Biomet, Inc. · Sep 5, 2003
- K041549 — ZIMMER TRABECULAR METAL HUMERAL STEM · Zimmer, Inc. · Sep 1, 2004
- K991603 — GRIT BLASTED HUMERAL STEM · Encore Orthopedics, Inc. · Jun 29, 1999
