SpaceFix Shoulder Spacer

510(k) Number

K252443 ↗

FDA Product Code

MBB

FDA applicant

G21, S.R.L.

Device Class

Class II

Regulation

21 CFR Part 888.3027

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• G3 40 Radiopaque Bone Cement

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• OrthoSteady G Bone Cement

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See all devices from G21 S.R.L. →

• What is the primary purpose of the SpaceFix Shoulder Spacer in orthopedic revision surgery?

  The SpaceFix Shoulder Spacer is designed as a temporary, modular bone cement device to facilitate joint debridement and deliver antibiotics during a two-stage procedure for shoulder prosthetic joint infections. It acts as a spacer to create space between bone and implant, allowing for infection control while the patient undergoes treatment before reimplantation.

• How is the SpaceFix Shoulder Spacer supplied, and is it reusable?

  The SpaceFix Shoulder Spacer is supplied as sterile, disposable modular molds paired with a metal stem for reinforcement. It is not reusable—each spacer is intended for single-use only, with a temporary placement duration of up to 180 days. The reusable component is the accompanying instrument kit used for intraoperative modular configuration.

• What types of patients is the SpaceFix Shoulder Spacer intended for, and how is it configured?

  The spacer is intended for skeletally mature patients undergoing revision of total or hemi shoulder arthroplasty due to prosthetic joint infections. Its modular design allows for intraoperative customization using a reusable instrument kit, enabling precise configuration to fit the patient’s anatomy during surgery.

• What regulatory pathways has the SpaceFix Shoulder Spacer undergone, and how is it classified?

  The SpaceFix Shoulder Spacer has undergone FDA 510(k) clearance and MDD authorization, confirming it is classified as a Class II medical device under both regulatory frameworks. The clearance was determined through a traditional review process by the FDA’s Orthopedic (OR) Advisory Committee, with a decision date of September 15, 2025.

• Are there specific storage requirements for the SpaceFix Shoulder Spacer before use?

  While the exact storage conditions are not detailed in the provided data, the spacer is supplied sterile and disposable, so it should be stored according to standard sterile medical device protocols—typically in a clean, dry environment, protected from contamination, and within its expiration date. Always follow manufacturer instructions for optimal preservation.