Staple, Fixation, Bone

Device Code: 4531

Product Code(s): JDR

Device Classification Information

• Device Type ID: 4531
• Device Name: Staple, Fixation, Bone
• Regulation Description: Single/multiple Component Metallic Bone Fixation Appliances And Accessories.
• 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: 888.3030 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JDR
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 11-184 ISO 8827 First Edition 1988-10-15
  Implants For Surgery - Staples With Parallel Legs For Orthopaedic Use - General Requirements
• 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
• 11-228 ASTM F564-10 (Reapproved 2015)
  Standard Specification And Test Methods For Metallic Bone Staples
• 11-325 ASTM F564-17
  Standard Specification And Test Methods For Metallic Bone Staples

Total Product Life Cycle

• Device Type ID: 4531
• Device: Staple, Fixation, Bone
• Product Code: JDR
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Single/multiple Component Metallic Bone Fixation Appliances And Accessories.
• CFR Regulation Number: 888.3030 [🔎]

Premarket Reviews
Manufacturer	Decision
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMEDICAL ENT., INC.
	SUBSTANTIALLY EQUIVALENT	2
BIOMEDICAL ENTERPRISES
	SUBSTANTIALLY EQUIVALENT	2
BIOMEDICAL ENTERPRISES, INC
	SUBSTANTIALLY EQUIVALENT	1
BIOMEDICAL ENTERPRISES, INC.
	SUBSTANTIALLY EQUIVALENT	2
BIOMET
	SUBSTANTIALLY EQUIVALENT	3
CROSSROADS EXTREMITY SYSTEMS LLC
	SUBSTANTIALLY EQUIVALENT	2
DALLEN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
FIRST RAY LLC
	SUBSTANTIALLY EQUIVALENT	2
FUSION ORTHOPEDICS, LLC.
	SUBSTANTIALLY EQUIVALENT	1
IN2BONES SAS
	SUBSTANTIALLY EQUIVALENT	3
INSTRATEK, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDSHAPE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
MERETE MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
NEXTREMITY SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NOVATSEP
	SUBSTANTIALLY EQUIVALENT	1
ORTHOHELIX SURGICAL DESIGN
	SUBSTANTIALLY EQUIVALENT	1
OT MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
PARAGON 28
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES (USA) PRODUCTS LLC / MEDICAL DEVICE BUSINESS SERVICE
	SUBSTANTIALLY EQUIVALENT	1
TORNIER INC.
	SUBSTANTIALLY EQUIVALENT	1
TRILLIANT SURGICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Break	156
Adverse Event Without Identified Device Or Use Problem	28
Material Frayed	27
Migration Or Expulsion Of Device	21
Insufficient Information	18
Fracture	16
Detachment Of Device Or Device Component	14
Device Operates Differently Than Expected	10
Activation, Positioning Or Separation Problem	9
Appropriate Term/Code Not Available	9
Material Split, Cut Or Torn	9
Positioning Failure	9
Difficult To Insert	6
Mechanical Jam	5
Failure To Advance	5
Migration	5
Improper Or Incorrect Procedure Or Method	4
Separation Failure	4
Material Rupture	4
Difficult To Position	4
Device Contaminated During Manufacture Or Shipping	3
Bent	3
Difficult Or Delayed Positioning	3
No Apparent Adverse Event	2
Device-Device Incompatibility	2
Unintended Movement	2
Packaging Problem	2
Difficult To Advance	2
Moisture Or Humidity Problem	1
Malposition Of Device	1
Needle	1
Crack	1
Detachment Of Device Component	1
Device Contamination With Chemical Or Other Material	1
Material Deformation	1
Device Damaged By Another Device	1
Device Issue	1
Loosening Of Implant Not Related To Bone-Ingrowth	1
Device Dislodged Or Dislocated	1
Disassembly	1
Unintended Ejection	1
Use Of Device Problem	1
Contamination / Decontamination Problem	1
Connection Problem	1
Material Disintegration	1
Device Operational Issue	1
Material Twisted / Bent	1
Suture	1
Failure To Adhere Or Bond	1
Staple	1
Total Device Problems	404

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomet, Inc.	II	Apr-02-2015
2	Crossroads Extremity Systems Llc	II	Mar-20-2017
3	In2bones USA, LLC	II	Dec-22-2018
4	Integra LifeSciences Corp.	III	Mar-04-2017
5	Paragon 28, Inc.	II	Jun-20-2018
6	Stryker Howmedica Osteonics Corp.	II	Feb-23-2016
7	TriMed Inc.	II	Jun-20-2018

TPLC Last Update: 2019-04-02 20:51:12