AccessGUDID - DEVICE: SpaceFlex Acetabular Cup (08058964727923)

GUDID

Device Identifier (DI) Information

Brand Name: SpaceFlex Acetabular Cup
Version or Model: 900203
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: G21 SRL

Primary DI Number: 08058964727923
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 431529195 *Terms of Use

Device Description: The SpaceFlex Acetabular Cup consists of disposable cement spacer molds indicated for use to mold a temporary Acetabular cup replacement for skeletally mature patients undergoing a two-stage procedure due to a septic process. The temporary prosthesis is molded using low viscosity antibiotic polymethylmethacrylate bone cement (G3A 40 bone cement) and positioned into the acetabular cavity following removal of the existing acetabular and femoral components and radical debridement. The molded acetabular cup is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The molded temporary Acetabular cup prosthesis is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (Bone Cement), the molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers) throughout the implant period.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45105	Orthopaedic cement spacer mould	A moulding device designed to form an implantable provisional joint prosthesis component out of orthopaedic cement (otherwise known as a cement spacer), which is used in two-stage joint revision typically to treat joint arthroplasty infection. It is filled with prepared antibiotic-containing bone cement which cures into the shape of the prosthesis and is subsequently placed into the joint space until replaced with a revision joint prosthesis. It is typically made of silicone and available in a variety of shapes and sizes for different joint applications. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223441	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dba8d5c8-cbca-4fda-af0f-c625b682cf9d
Public Version Date: April 19, 2023
Public Version Number: 1
DI Record Publish Date: April 11, 2023