AccessGUDID - DEVICE: Synicem Knee Spacer R65 (15060155712144)

GUDID

Device Identifier (DI) Information

Brand Name: Synicem Knee Spacer R65
Version or Model: 885440
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 885440
Company Name: BIOCOMPOSITES LTD

Primary DI Number: 15060155712144
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 424382307 *Terms of Use

Device Description: Asymmetric, Femoral/Tibia 65, Right Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
33982	Orthopaedic cement spacer	A prefabricated device made of orthopaedic bone cement [e.g., polymethylmethacrylate (PMMA)], with an appropriate antibiotic, that is temporarily placed into a joint space to function as a carrier for the local delivery of antibiotic drugs and to prevent bone-on-bone contact and contraction of soft-tissue during surgical treatment of an infected joint. The shape and size of the device is modified to fit the joint space. This non-weight-bearing spacer remains in place until the infection clears; it is then removed and replaced with a conventional joint prosthesis. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K242865	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
Device Size Text, specify: Asymmetric, Femoral/Tibia 65

Device Record Status

Public Device Record Key: 993e615a-87a7-4c36-a8b1-1c042a31b0b0
Public Version Date: July 16, 2025
Public Version Number: 1
DI Record Publish Date: July 08, 2025