Screw, Fixation, Bone, Non-spinal, Metallic

Device Code: 4636

Product Code(s): NDJ

Device Classification Information

• Device Type ID: 4636
• Device Name: Screw, Fixation, Bone, Non-spinal, Metallic
• Regulation Description: Smooth Or Threaded Metallic Bone Fixation Fastener.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Orthopedic Devices (DOD); Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
• Submission Type: 510(k)
• CFR Regulation Number: 888.3040 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NDJ
• 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
• 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
• 11-242 ASTM F1839-08 (Reapproved 2016)
  Standard Specification For Rigid Polyurethane Foam For Use As A Standard Material For Testing Orthopaedic Devices And Instruments

Total Product Life Cycle

• Device Type ID: 4636
• Device: Screw, Fixation, Bone, Non-spinal, Metallic
• Product Code: NDJ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Smooth Or Threaded Metallic Bone Fixation Fastener.
• CFR Regulation Number: 888.3040 [🔎]

Device Problems
Insufficient Information	19
Loss Of Osseointegration	17
Appropriate Term/Code Not Available	14
Metal Shedding Debris	9
Adverse Event Without Identified Device Or Use Problem	7
Noise, Audible	7
Loose Or Intermittent Connection	5
Migration Or Expulsion Of Device	3
Device Dislodged Or Dislocated	2
Malposition Of Device	2
Inadequacy Of Device Shape And/or Size	2
Material Deformation	1
Device Packaging Compromised	1
Fracture	1
Corroded	1
Total Device Problems	91

Recalls
Manufacturer		Recall Class	Date Posted
1	Zimmer, Inc.	II	May-29-2015
2	Zimmer, Inc.	II	Feb-20-2014

TPLC Last Update: 2019-04-02 20:53:13