SpaceFix Shoulder Spacer

The SpaceFix Shoulder Spacer is a temporary shoulder spacer made of PMMA bone cement with gentamicin and a stainless steel reinforcement core. It is intended for temporary use (maximum 180 days) in skeletally mature patients undergoing total or hemi shoulder arthroplasty revision due to prosthetic joint infection, with the device implanted in the glenoid cavity and humeral canal after prosthesis explantation and debridement.

The device is available in four sizes based on stem and head diameter and stem length. It uses G3A formula bone cement (already FDA-approved) with a stainless steel core per AISI 316LVM standard, identical to the primary predicate SpaceFlex Shoulder. The key difference from the primary predicate is that SpaceFix is premolded, whereas SpaceFlex is molded in the operating room.

The document references recognized consensus standards but does not explicitly cite specific ISO, IEC, or ASTM standards by number. Testing included biocompatibility, shelf-life, sterilization validation, pyrogenicity/endotoxin monitoring, gentamicin elution profile, fatigue strength, package integrity, and gentamicin stability.

Both the subject device and predicate devices are made of PMMA with gentamicin for identical indications (revision surgeries). The only material and design difference—premolding versus operating room molding—does not raise safety or effectiveness concerns because the molding process is identical and performance testing found the subject device equivalent to the primary predicate. Therefore, no significant technological differences exist between subject and predicate devices.