Libertas

GUDID 00810008120965

12/14 Taper HNSS 36/+0 Modular Femoral Head

MAXX ORTHOPEDICS, INC.

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 00810008120965
• NIH Device Record Key: 27988813-1721-4610-971b-114bd3133363
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Libertas
• Version Model Number: MO-HDAM-36/00
• Company DUNS: 792030103
• Company Name: MAXX ORTHOPEDICS, 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: 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: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810008120965 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180973

FDA Product Code

• JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-31
• Device Publish Date: 2025-07-23

On-Brand Devices [Libertas]

• 00810008121887: Bone Screw Ø6.5 x 50mm
• 00810008121870: Bone Screw Ø6.5 x 45mm
• 00810008121863: Bone Screw Ø6.5 x 40mm
• 00810008121856: Bone Screw Ø6.5 x 35mm
• 00810008121849: Bone Screw Ø6.5 x 30mm
• 00810008121832: Bone Screw Ø6.5 x 25mm
• 00810008121825: Bone Screw Ø6.5 x 20mm
• 00810008121818: Bone Screw Ø6.5 x 15mm
• 00810008126691: Taper Uncemented Femoral Stem Size 22/128° Mini TR
• 00810008126684: Taper Uncemented Femoral Stem Size 20/128° Mini TR
• 00810008126677: Taper Uncemented Femoral Stem Size 18/128° Mini TR
• 00810008126660: Taper Uncemented Femoral Stem Size 17/128° Mini TR
• 00810008126653: Taper Uncemented Femoral Stem Size 16/128° Mini TR
• 00810008126646: Taper Uncemented Femoral Stem Size 15/128° Mini TR
• 00810008126639: Taper Uncemented Femoral Stem Size 14/128° Mini TR
• 00810008126622: Taper Uncemented Femoral Stem Size 13/128° Mini TR
• 00810008126615: Taper Uncemented Femoral Stem Size 12/128° Mini TR
• 00810008126608: Taper Uncemented Femoral Stem Size 11/128° Mini TR
• 00810008126592: Taper Uncemented Femoral Stem Size 10/128° Mini TR
• 00810008126585: Taper Uncemented Femoral Stem Size 09/128° Mini TR
• 00810008126578: Taper Uncemented Femoral Stem Size 08/128° Mini TR
• 00810008126561: Taper Uncemented Femoral Stem Size 07/128° Mini TR
• 00810008126554: Taper Uncemented Femoral Stem Size 06/128° Mini TR
• 00810008126547: Taper Uncemented Femoral Stem Size 05/128° Mini TR
• 00810008126530: Taper Uncemented Femoral Stem Size 04/128° Mini TR
• 00840333904541: Modular Liner BIOLOX delta Size MK/40
• 00840333904534: Modular Liner BIOLOX delta Size MK/36
• 00840333904527: Modular Liner BIOLOX delta Size MJ/40
• 00840333904510: Modular Liner BIOLOX delta Size MJ/36
• 00840333904503: Modular Liner BIOLOX delta Size MJ/32
• 00840333904497: Modular Liner BIOLOX delta Size MH/40
• 00840333904480: Modular Liner BIOLOX delta Size MH/36
• 00840333904473: Modular Liner BIOLOX delta Size MH/32
• 00840333904466: Modular Liner BIOLOX delta Size MF/36
• 00840333904459: Modular Liner BIOLOX delta Size MF/32
• 00840333904442: Modular Liner BIOLOX delta Size MD/32
• 00840333903919: SS 316L+UHMWPE1050 44/28 Bipolar Monoblock Shell
• 00840333903902: SS 316L+UHMWPE1050 43/22 Bipolar Monoblock Shell
• 00840333903896: SS 316L+UHMWPE1050 42/22 Bipolar Monoblock Shell
• 00840333903889: SS 316L+UHMWPE1050 41/22 Bipolar Monoblock Shell
• 00840333903872: SS 316L+UHMWPE1050 40/22 Bipolar Monoblock Shell
• 00840333903865: SS 316L+UHMWPE1050 39/22 Bipolar Monoblock Shell
• 00840333903858: SS 316L+UHMWPE1050 38/22 Bipolar Monoblock Shell
• 00840333903841: SS 316L+UHMWPE1050 37/22 Bipolar Monoblock Shell
• 00840333903834: HXLPE MK/28 Dual Mobility Modular Poly Insert
• 00840333903827: HXLPE MK/22 Dual Mobility Modular Poly Insert
• 00840333903810: HXLPE MJ/28 Dual Mobility Modular Poly Insert
• 00840333903803: HXLPE MJ/22 Dual Mobility Modular Poly Insert
• 00840333903797: HXLPE MH/28 Dual Mobility Modular Poly Insert
• 00840333903780: HXLPE MH/22 Dual Mobility Modular Poly Insert