SpaceFlex Shoulder

GUDID 08058964724977

Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone cement and inserted into the humeral medullary canal and glenoid cavity of the shoulder following removal of the existing humeral and glenoideal cavity implants and debridement. SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.). Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitation throughout the implant period. The device can exclusively be used by competent healthcare personnel who has complete scientific and anatomical knowledge.

G21 SRL

Orthopaedic cement spacer mould

• Primary Device ID: 08058964724977
• NIH Device Record Key: 63a69553-b909-421d-90ef-1747fa835039
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpaceFlex Shoulder
• Version Model Number: 900001 084215
• Company DUNS: 431529195
• Company Name: G21 SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	08058964724977 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202338

FDA Product Code

• MBB: Bone Cement, Antibiotic

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: 2021-03-15
• Device Publish Date: 2021-03-05

On-Brand Devices [SpaceFlex Shoulder]

• 08058964726087: "Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a te
• 08058964726070: Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a tem
• 08058964726063: Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a tem
• 08058964726056: Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a tem
• 08058964726049: Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a tem
• 08058964724977: Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a tem