RIGIDFIX

Basic Information

• Brand Name: RIGIDFIX
• Primary DI: 10886705000920
• Version / Model: 210333
• Catalog Number: 210333
• Company Name: DEPUY MITEK, LLC
• Labeler DUNS: 190572854
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-01
• Public Version: 7
• Public Version Date: 2025-10-06
• Public Version Status: Update
• Public Device Record Key: a3c05585-0738-4272-a474-c549e1cdaa6c
• Distribution End Date: 2025-10-06

Device Description

RIGIDFIX TIBIAL ST CROSS PIN KIT (2) each ST Cross Pins, 3.3mm x 42mm Absorbable Poly Lactic Acid (PLA), (2) each Sleeve Assemblies, and (1) each Interlocking Trocar

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MAI	FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE	Orthopedic	888.3030	2
HWC	Screw, fixation, bone	Orthopedic	888.3040	2
JDR	Staple, fixation, bone	Orthopedic	888.3030	2
HTY	PIN, FIXATION, SMOOTH	Orthopedic	888.3040	2
MBI	Fastener, fixation, nondegradable, soft tissue	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45061	Tendon/ligament bone anchor, bioabsorbable	A bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10886705000920	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K010633	000
K150209	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: High: 26 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: High: 80 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: High: 80 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: High: 26 Degrees Celsius