Tornier HRS Max

Basic Information

• Brand Name: Tornier HRS Max
• Primary DI: 00840338603784
• Version / Model: ARS1024316
• Catalog Number: ARS1024316
• Company Name: TORNIER, INC.
• Labeler DUNS: 968990812
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-19
• Public Version: 1
• Public Version Date: 2025-11-27
• Public Version Status: New
• Public Device Record Key: 90dacb1a-01b7-4f07-8ddd-1da7f6fc2a31

Device Description

Reamer Planer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSD	PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED	Orthopedic	888.3690	2
KWT	PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED	Orthopedic	888.3650	2
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED	Orthopedic	888.3660	2
PHX	shoulder prosthesis, reverse configuration	Orthopedic	888.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45114	Bone-resection orthopaedic reamer, reusable	An orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840338603784	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K251686	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	16	Millimeter
Device Size Text, specify			Size: 16