InSitu Hip System 10-33-0048

GUDID 00816127023675

Acetabular Cup, Size 48, Solid Anodized

NEXTSTEP ARTHROPEDIX, LLC

Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell

• Primary Device ID: 00816127023675
• NIH Device Record Key: ade44528-3514-4da2-8b9e-eec8e4e4b649
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InSitu Hip System
• Version Model Number: 10-33-0048
• Catalog Number: 10-33-0048
• Company DUNS: 060211165
• Company Name: NEXTSTEP ARTHROPEDIX, LLC
• 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

Customer Support Contacts

• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us
• Phone: 3307337600
• Email: info@theken.us

Device Dimensions

• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter
• Outer Diameter: 48 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816127023675 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161184

FDA Product Code

• OQI: Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

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: 2018-02-16

On-Brand Devices [InSitu Hip System]

• 00816127024115: Femoral Head, 40mm, +10.5mm, CoCr Skirted
• 00816127024078: Femoral Stem, Size 0, Lateralized
• 00816127024061: Femoral Stem, Size 0, Standard
• 00816127023774: Acetabular Cup, Size 68, Solid Anodized
• 00816127023767: Acetabular Cup, Size 66, Solid Anodized
• 00816127023750: Acetabular Cup, Size 64, Solid Anodized
• 00816127023743: Acetabular Cup, Size 62, Solid Anodized
• 00816127023736: Acetabular Cup, Size 60, Solid Anodized
• 00816127023729: Acetabular Cup, Size 58, Solid Anodized
• 00816127023712: Acetabular Cup, Size 56, Solid Anodized
• 00816127023705: Acetabular Cup, Size 54, Solid Anodized
• 00816127023699: Acetabular Cup, Size 52, Solid Anodized
• 00816127023682: Acetabular Cup, Size 50, Solid Anodized
• 00816127023675: Acetabular Cup, Size 48, Solid Anodized
• 00816127023668: Acetabular Cup, Size 46, Solid Anodized
• 00816127022753: Acetabular Liner, Size 54/56 x 36mm ID , Neutral
• 00816127022746: Acetabular Liner, Size 52 x 36mm ID, Neutral
• 00816127022739: Acetabular Liner, Size 50 x 36mm ID, Neutral
• 00816127022722: Acetabular Liner, Size 48 x 32mm ID, Neutral
• 00816127022715: Acetabular Liner, Size 46 x 32mm ID, Neutral
• 00816127022708: Acetabular Liner, Size 42/44 x 28mm ID, Neutral
• 00816127022692: Acetabular Cup, Size 44, Solid, Anodized
• 00816127022685: Acetabular Cup, Size 42, Solid, Anodized
• 00816127022678: Acetabular Cup, Size 68, Holed, Anodized
• 00816127022661: Acetabular Cup, Size 66, Holed, Anodized
• 00816127022654: Acetabular Cup, Size 64, Holed, Anodized
• 00816127022647: Acetabular Cup, Size 62, Holed, Anodized
• 00816127022630: Acetabular Cup, Size 60, Holed, Anodized
• 00816127022623: Acetabular Cup, Size 58, Holed, Anodized
• 00816127022616: Acetabular Cup, Size 56, Holed, Anodized
• 00816127022609: Acetabular Cup, Size 54, Holed, Anodized
• 00816127022593: Acetabular Cup, Size 52, Holed, Anodized
• 00816127022586: Acetabular Cup, Size 50, Holed, Anodized
• 00816127022579: Acetabular Cup, Size 48, Holed, Anodized
• 00816127022562: Acetabular Cup, Size 46, Holed, Anodized
• 00816127022555: Femoral Head, 40mm, +8mm, Biolox
• 00816127022548: Femoral Head, 40mm, +4mm, Biolox
• 00816127022531: Femoral Head, 40mm, 0mm, Biolox
• 00816127022524: Femoral Head, 40mm, -4mm, Biolox
• 00816127022517: Femoral Head, 36mm, +8mm, Biolox
• 00816127022500: Femoral Head, 36mm, +4mm, Biolox
• 00816127022494: Femoral Head, 36mm, 0mm, Biolox
• 00816127022487: Femoral Head, 36mm, -4mm, Biolox
• 00816127022470: Femoral Head, 32mm, +7mm, Biolox
• 00816127022463: Femoral Head, 32mm, +4mm, Biolox
• 00816127022456: Femoral Head, 32mm, 0mm, Biolox
• 00816127022449: Femoral Head, 32mm, -4mm, Biolox
• 00816127022432: Femoral Head, 28mm, +3.5mm, Biolox
• 00816127022425: Femoral Head, 28mm, 0mm, Biolox
• 00816127022418: Femoral Head, 28mm, -3.5mm, Biolox