FOUNDATION® HIP SYSTEM

GUDID 00888912110662

Foundation PS Femur, NonPorous, TiNbN Coated, Sz 7 RT

Encore Medical, L.P.

Coated hip femur prosthesis, modular

• Primary Device ID: 00888912110662
• NIH Device Record Key: 4a93784e-82d8-476f-88c4-2638c873ffde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOUNDATION® HIP SYSTEM
• Version Model Number: 214-09-007
• Company DUNS: 154074504
• Company Name: Encore Medical, L.P.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888912110662 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122239

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-03

Devices Manufactured by Encore Medical, L.P.

• 00190446897019 - DJO SURGICAL: 2025-04-17 SPECIAL, EMPOWR KNEE MODULAR FEMORAL SIZER BODY
• 00190446897033 - DJO SURGICAL: 2025-04-17 SPECIAL, EMPOWR KNEE MODULAR FEMORAL SIZER FEET SIZE 2-4mm
• 00190446897057 - DJO SURGICAL: 2025-04-17 SPECIAL, EMPOWR KNEE MODULAR FEMORAL SIZER FEET SIZE 5-8mm
• 00190446897064 - DJO SURGICAL: 2025-04-17 SPECIAL, EMPOWR KNEE MODULAR FEMORAL SIZER FEET SIZE 9-11mm
• 00190446897071 - DJO SURGICAL: 2025-04-17 SPECIAL, EMPOWR KNEE REMOVABLE ARVIS ATTACHMENT
• 00190446897088 - DJO SURGICAL: 2025-04-17 SPECIAL, EMPOWR KNEE +2mm SHIMS, SIZE 2-4mm
• 00190446897095 - DJO SURGICAL: 2025-04-17 SPECIAL, EMPOWR KNEE +2mm SHIMS, SIZE 5-8mm
• 00190446897101 - DJO SURGICAL: 2025-04-17 SPECIAL, EMPOWR KNEE +2mm SHIMS, SIZE 9-11mm