Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained

Device Code: 4684

Product Code(s): PKC

Definition: Replacement Of The Humeral Head For Total Anatomic Shoulder Arthroplasty

Device Classification Information

• Device Type ID: 4684
• Device Name: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
• Physical State: Short Metallic Humeral Stem Contained Entirely Within The Metaphysis.
• Technical Method: Humeral Head Is Resected And Canal Is Created To Accept Humeral Stem Component
• Target Area: Shoulder. Proximal Humerus.
• Regulation Description: Shoulder Joint Metal/polymer Semi-constrained Cemented Prosthesis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Orthopedic Devices (DOD); Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1)
• Submission Type: 510(k)
• CFR Regulation Number: 888.3660 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: PKC
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 8-423 ASTM F2565-13
  Standard Guide For Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms For Surgical Implant Applications
• 8-424 ASTM F2695-12
  Standard Specification For Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) And Fabricated Forms For Surgical Implant Applications

Total Product Life Cycle

• Device Type ID: 4684
• Device: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
• Product Code: PKC
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Shoulder Joint Metal/polymer Semi-constrained Cemented Prosthesis.
• CFR Regulation Number: 888.3660 [🔎]

Premarket Reviews
Manufacturer	Decision
TORNIER
	SUBSTANTIALLY EQUIVALENT	1
TORNIER INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER GMBH
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Appropriate Term/Code Not Available	3
Device Dislodged Or Dislocated	2
Insufficient Information	2
Loosening Of Implant Not Related To Bone-Ingrowth	1
Failure To Adhere Or Bond	1
Migration Or Expulsion Of Device	1
Total Device Problems	10

TPLC Last Update: 2019-04-02 20:53:53