iNSitu Total Hip System

GUDID 00816127024887

Cemented Femoral Stem, Size 10, Lateralized

NEXTSTEP ARTHROPEDIX, LLC

Uncoated hip femur prosthesis, modular

• Primary Device ID: 00816127024887
• NIH Device Record Key: 5106eba1-f6d0-4afe-b1a6-8fc9aaa1ee03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iNSitu Total Hip System
• Version Model Number: 10-16-0010
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816127024887 [Primary]

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

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

[00816127024887]

Ethylene Oxide

[00816127024887]

Ethylene Oxide

[00816127024887]

Ethylene Oxide

[00816127024887]

Ethylene Oxide

[00816127024887]

Ethylene Oxide

[00816127024887]

Ethylene Oxide

[00816127024887]

Ethylene Oxide

[00816127024887]

Ethylene Oxide

[00816127024887]

Ethylene Oxide

[00816127024887]

Ethylene Oxide

[00816127024887]

Ethylene Oxide

[00816127024887]

Ethylene Oxide

[00816127024887]

Ethylene Oxide

[00816127024887]

Ethylene Oxide

[00816127024887]

Ethylene Oxide

[00816127024887]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-16
• Device Publish Date: 2024-08-08

On-Brand Devices [iNSitu Total Hip System]

• 00816127029189: Femoral Stem, Size 14, Lateral, Taper Coated
• 00816127029172: Femoral Stem, Size 13, Lateral, Taper Coated
• 00816127029165: Femoral Stem, Size 12, Lateral, Taper Coated
• 00816127029158: Femoral Stem, Size 11, Lateral, Taper Coated
• 00816127029141: Femoral Stem, Size 10, Lateral, Taper Coated
• 00816127029134: Femoral Stem, Size 9, Lateral, Taper Coated
• 00816127029127: Femoral Stem, Size 8, Lateral, Taper Coated
• 00816127029110: Femoral Stem, Size 7, Lateral, Taper Coated
• 00816127029103: Femoral Stem, Size 6, Lateral, Taper Coated
• 00816127029097: Femoral Stem, Size 5, Lateral, Taper Coated
• 00816127029080: Femoral Stem, Size 4, Lateral, Taper Coated
• 00816127029073: Femoral Stem, Size 3, Lateral, Taper Coated
• 00816127029066: Femoral Stem, Size 2, Lateral, Taper Coated
• 00816127029059: Femoral Stem, Size 1, Lateral, Taper Coated
• 00816127029042: Femoral Stem, Size 0, Lateral, Taper Coated
• 00816127029035: Femoral Stem, Size 14, Standard, Taper Coated
• 00816127029028: Femoral Stem, Size 13, Standard, Taper Coated
• 00816127029011: Femoral Stem, Size 12, Standard, Taper Coated
• 00816127029004: Femoral Stem, Size 11, Standard, Taper Coated
• 00816127028991: Femoral Stem, Size 10, Standard, Taper Coated
• 00816127028984: Femoral Stem, Size 9, Standard, Taper Coated
• 00816127028977: Femoral Stem, Size 8, Standard, Taper Coated
• 00816127028960: Femoral Stem, Size 7, Standard, Taper Coated
• 00816127028953: Femoral Stem, Size 6, Standard, Taper Coated
• 00816127028946: Femoral Stem, Size 5, Standard, Taper Coated
• 00816127028939: Femoral Stem, Size 4, Standard, Taper Coated
• 00816127028922: Femoral Stem, Size 3, Standard, Taper Coated
• 00816127028915: Femoral Stem, Size 2, Standard, Taper Coated
• 00816127028908: Femoral Stem, Size 1, Standard, Taper Coated
• 00816127028892: Femoral Stem, Size 0, Standard, Taper Coated
• 00816127025082: Lateralized Liner Trial Size 62/68 x 40mm ID
• 00816127025075: Lateralized Liner Trial Size 58/60 x 40mm ID
• 00816127025068: Lateralized Liner Trial Size 54/56 x 40mm ID
• 00816127025051: Lateralized Liner Trial Size 62/68 x 36mm ID
• 00816127025044: Lateralized Liner Trial Size 58/60 x 36mm ID
• 00816127025037: Lateralized Liner Trial Size 54/56 x 36mm ID
• 00816127025020: Lateralized Liner Trial Size 52 x 36mm ID
• 00816127025013: Lateralized Liner Trial Size 50 x 36mm ID
• 00816127025006: Lateralized Liner Trial Size 48 x 32mm ID
• 00816127024993: Lateralized Liner Trial Size 46 x 32mm ID
• 00816127024986: Lateralized Liner Trial Size 42/44 x 28mm ID
• 00816127024924: Cemented Femoral Stem, Size 14, Lateralized
• 00816127024917: Cemented Femoral Stem, Size 13, Lateralized
• 00816127024900: Cemented Femoral Stem, Size 12, Lateralized
• 00816127024894: Cemented Femoral Stem, Size 11, Lateralized
• 00816127024887: Cemented Femoral Stem, Size 10, Lateralized
• 00816127024870: Cemented Femoral Stem, Size 9, Lateralized
• 00816127024863: Cemented Femoral Stem, Size 8, Lateralized
• 00816127024856: Cemented Femoral Stem, Size 7, Lateralized
• 00816127024849: Cemented Femoral Stem, Size 6, Lateralized