JOURNEY 74023422

GUDID 03596010516916

RENASYS TIBIAL INSERT PS STD 1-2 LEFT 10 MM

Smith & Nephew, Inc.

Uncoated knee tibia prosthesis, polyethylene

• Primary Device ID: 03596010516916
• NIH Device Record Key: 9cf0f478-02dd-4df3-b575-39ff961a8ed1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JOURNEY
• Version Model Number: 74023422
• Catalog Number: 74023422
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010516916 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042515

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-29

On-Brand Devices [JOURNEY]

• 00885556741535: LOW PROFILE CEMENT CLAMP
• 00885556740866: PATELLA RESECTION GUIDE
• 00885556740828: FLEXIBLE IM ROD
• 00885556740811: ANTERIOR FEMORAL CUTTING BLOCK
• 00885556740804: DISTAL FEMORAL RESECTION CHECK
• 00885556740798: DISTAL ALIGNMENT GUIDE - RIGHT
• 00885556740781: DISTAL ALIGNMENT GUIDE - LEFT
• 00885556740774: DISTAL RESECTION BLOCK - RIGHT
• 00885556740767: DISTAL RESECTION BLOCK - LEFT
• 00885556740750: DISTAL ALIGNMENT OFFSET ROD - RIGHT
• 00885556740743: DISTAL ALIGNMENT OFFSET ROD - LEFT
• 00885556740736: NEUTRAL DISTAL ALIGNMENT OFFSET ROD
• 00885556737705: FEMORAL SIZING GUIDE - RIGHT
• 00885556737699: FEMORAL SIZING GUIDE - LEFT
• 00885556737682: TIBIA CUTTING BLOCK - RIGHT
• 00885556737675: TIBIA CUTTING BLOCK - LEFT
• 00885556737668: FEMORAL SIZING STYLUS
• 00885556735923: ADJUSTABLE TIBIA STYLUS
• 00885556719169: 2MM RECUT BLOCK
• 00885556714539: SIZING GUIDE WITH SHORT PADDLES - RIGHT
• 00885556714522: SIZING GUIDE WITH SHORT PADDLES - LEFT
• 00885556713419: MODIFIED TIBIAL ALIGNMENT TUBE
• 00885556707555: 2MM RECUT BLOCK
• 00885556697733: FEMORAL NOTCH PREP GUIDE SZ 9~10
• 00885556697726: FEMORAL NOTCH PREP GUIDE SZ 6~8
• 00885556697719: FEMORAL NOTCH PREP GUIDE SZ 3~5
• 00885556697702: FEMORAL NOTCH PREP GUIDE SZ 1~2
• 00885556697696: BUMPER 9-10 R
• 00885556697689: BUMPER 9-10 L
• 00885556697672: BUMPER 1-8 R
• 00885556697665: BUMPER 1-8 L
• 00885556697658: JOURNEY CR FEMORAL IMPACTOR
• 00885556697450: FLEXIBLE IM ROD
• 00885556697405: NO ROTATION JOURNEY SIZING STYLUS
• 00885556697146: LOW PROFILE DONUT PATELLA CLAMP
• 00885556694176: JOURNEY RESURFACING PATELLAR DRILL
• 00885556693087: RIGHT TISSUE SPARING POSTERIOR PADDLES
• 00885556693070: LEFT TISSUE SPARING POSTERIOR PADDLES
• 00885556692677: JOURNEY LOCKING TIBIAL IMPACTOR
• 00885556692325: RIGHT MODIFIED TIBIAL CUTTING BLOCK
• 00885556692318: LEFT MODIFIED TIBIAL CUTTING BLOCK
• 00885556689899: PATELLA DRILL GUIDE 38-41MM
• 00885556689882: PATELLA DRILL GUIDE 32-35MM
• 00885556689875: PATELLA DRILL GUIDE 26-29MM
• 00885556689868: PATELLA CLAMP LEVER
• 00885556689196: TIBIAL TRIAL INSERT FORK HANDLE
• 00885556687413: XR ANTERIOR EMINENCE CHISEL GUIDE LONG
• 00885556685990: TIBIAL STYLUS WITH SPRING FOOT 2MM/9MM
• 00885556685983: NONSLOTTED 3 DEG TIBIA BLOCK RIGHT
• 00885556685976: NONSLOTTED 3 DEG TIBIA BLOCK LEFT