Prosthesis, Elbow, Semi-constrained, Cemented

Device Code: 4520

Product Code(s): JDB

Device Classification Information

• Device Type ID: 4520
• Device Name: Prosthesis, Elbow, Semi-constrained, Cemented
• Regulation Description: Elbow 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: 888.3160 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JDB
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 8-365 ASTM D1505-10
  Standard Test Method For Density Of Plastics By The Density-Gradient Technique
• 8-368 ASTM F2625-10 (Reapproved 2016)
  Standard Test Method For Measurement Of Enthalpy Of Fusion, Percent Crystallinity, And Melting Point Of Ultra-High-Molecular Weight Polyethylene By Means Of Differential Scanning Calorimetry
• 8-378 ASTM D792-13
  Standard Test Methods For Density And Specific Gravity (Relative Density) Of Plastics By Displacement
• 8-379 ISO 11542-2 First Edition 1998-11-15
  Plastics - Ultra-high-molecular-weight Polyethyelene (PE-UHMW) Moulding And Extrusion Materials - Part 2: Preparation Of Test Specimens And Determination Of Properties [Including: Technical Corrigendum 1 (2007)]
• 8-403 ASTM D638-14
  Standard Test Method For Tensile Properties Of Plastics
• 8-404 ASTM E647-15
  Standard Test Method For Measurement Of Fatigue Crack Growth Rates
• 11-197 ASTM F983-86 (Reapproved 2018)
  Standard Practice For Permanent Marking Of Orthopaedic Implant Components
• 11-199 ASTM F565-04 (Reapproved 2018)
  Standard Practice For Care And Handling Of Orthopedic Implants And Instruments
• 11-234 ASTM F732-00 (Reapproved 2011)
  Standard Test Method For Wear Testing Of Polymeric Materials Used In Total Joint Prostheses
• 11-275 ASTM F2381-10
  Standard Test Method For Evaluating Trans-Vinylene Yield In Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended For Surgical Implants By Infrared Spectroscopy
• 11-321 ASTM F2887-17
  Standard Specification For Total Elbow Prostheses
• 11-342 ASTM F732-17
  Standard Test Method For Wear Testing Of Polymeric Materials Used In Total Joint Prostheses

Total Product Life Cycle

• Device Type ID: 4520
• Device: Prosthesis, Elbow, Semi-constrained, Cemented
• Product Code: JDB
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Elbow Joint Metal/polymer Semi-constrained Cemented Prosthesis.
• CFR Regulation Number: 888.3160 [🔎]

Premarket Reviews
Manufacturer	Decision
TORNIER
	SUBSTANTIALLY EQUIVALENT	2
TORNIER INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Insufficient Information	36
Adverse Event Without Identified Device Or Use Problem	18
Migration Or Expulsion Of Device	12
Device Dislodged Or Dislocated	10
Mechanical Problem	9
Detachment Of Device Or Device Component	7
Disassembly	7
Fracture	4
Naturally Worn	4
Unstable	3
Migration	3
Appropriate Term/Code Not Available	3
Improper Or Incorrect Procedure Or Method	2
Device Operates Differently Than Expected	2
Packaging Problem	2
Break	2
Loose Or Intermittent Connection	2
Positioning Problem	1
Material Erosion	1
Difficult To Insert	1
Detachment Of Device Component	1
Loss Of Osseointegration	1
Device Issue	1
Loss Of Or Failure To Bond	1
Misassembled	1
Total Device Problems	134

Recalls
Manufacturer		Recall Class	Date Posted
1	Howmedica Osteonics Corp.	II	Aug-08-2018
2	Stryker Howmedica Osteonics Corp.	II	Aug-20-2015

TPLC Last Update: 2019-04-02 20:50:55