FDA.reportPublic FDA data

Orthopaedic cement spacer

Definition
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.
GUDID devices
294
Last updated
2026-06-11 06:05:53

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850011453476REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCRHCCH402026-06-01
00850011453483REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCRHCCH442026-06-01
00850011453490REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCRHCCH462026-06-01
00850011453506REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCRHPAC402026-06-01
00850011453513REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCRHPAC442026-06-01
00850011453520REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCRHPAC462026-06-01
04260102136670COPAL® exchange GHeraeus Medical GmbHhip S long2019-11-25
04260102136700COPAL® exchange GHeraeus Medical GmbHhip M long2019-11-25
04260102136731COPAL® exchange G Heraeus Medical GmbHhip L long2019-11-25
04260102136762COPAL® exchange GHeraeus Medical GmbHhip XL long2019-11-25
04260102136793COPAL® exchange GHeraeus Medical GmbHhip S short2019-11-25
04260102136823COPAL® exchange GHeraeus Medical GmbHhip M short2019-11-25
04260102136854COPAL® exchange GHeraeus Medical GmbHhip L short2019-11-25
04260102136915COPAL® exchange GHeraeus Medical GmbHknee S2019-12-02
04260102136946COPAL® exchange GHeraeus Medical GmbHknee M2019-12-02
04260102136977COPAL® exchange GHeraeus Medical GmbHknee L2019-12-02
04260102139176COPAL® exchange GHeraeus Medical GmbHhip S medium2022-05-15
04260102139206COPAL® exchange GHeraeus Medical GmbHhip M medium2022-05-15
08031497001586Interspace Tapered Wedge Stem TECRES SPASPC00232015-10-12
08031497001593Interspace Tapered Wedge Stem TECRES SPASPC01232015-10-12
08031497001609Interspace Tapered Wedge Stem TECRES SPASPC02232015-10-12
08031497001616Interspace Tapered Wedge Stem TECRES SPASPC03232015-10-12
08031497001623Interspace Tapered Wedge Stem TECRES SPASPC04232015-10-12
08031497001630Interspace Tapered Wedge Stem TECRES SPASPC05232015-10-12
28031497001870Interspace Knee ATS 60/07TECRES SPASPK04222019-08-14
28031497001887Interspace Knee ATS 60/12TECRES SPASPK05222019-08-14
28031497001894Interspace Knee ATS 80/07TECRES SPASPK06222019-08-14
28031497001900Interspace Knee ATS 80/12TECRES SPASPK07222019-08-14
M684200201091NexusMicroport Orthopedics Inc.200201092015-10-20
M684200201101NexusMicroport Orthopedics Inc.200201102015-10-20
M684200201111NexusMicroport Orthopedics Inc.200201112015-10-20
M684200201121NexusMicroport Orthopedics Inc.200201122015-10-20
M684200201131NexusMicroport Orthopedics Inc.200201132015-10-20
M684200201141NexusMicroport Orthopedics Inc.200201142015-10-20
M684200201151NexusMicroport Orthopedics Inc.200201152015-10-20
M684200201161NexusMicroport Orthopedics Inc.200201162015-10-20
M684200201171NexusMicroport Orthopedics Inc.200201172015-10-20
M684200201181NexusMicroport Orthopedics Inc.200201182015-10-20
M684200201191NexusMicroport Orthopedics Inc.200201192015-10-20
M684200201201NexusMicroport Orthopedics Inc.200201202015-10-20
M684200201211NexusMicroport Orthopedics Inc.200201212015-10-20
08031497003955Interspace GV Hip Spacer 46TECRES SPAIHGV46S2026-02-11
08031497003962Interspace GV Hip Spacer 54TECRES SPAIHGV54S2026-02-11
08031497003979Interspace GV Hip Spacer 60TECRES SPAIHGV60S2026-02-11
08031497003986Interspace GV Hip Spacer 46 XLTECRES SPAIHGV46L2026-02-11
08031497003993Interspace GV Hip Spacer 54 XLTECRES SPAIHGV54L2026-02-11
08031497004006Interspace GV Hip Spacer 60 XLTECRES SPAIHGV60L2026-02-11
08058964729217CeMend Shoulder SpacerG21 SRLAR-902-08422025-12-19
08058964729224CeMend Shoulder SpacerG21 SRLAR-902-10422025-12-19
08058964729231CeMend Shoulder SpacerG21 SRLAR-902-10482025-12-19
08058964729248CeMend Shoulder SpacerG21 SRLAR-902-12482025-12-19
15060155712021Synicem Hip Spacer 40CBIOCOMPOSITES LTD8854302025-07-08
15060155712038Synicem Hip Spacer 48CBIOCOMPOSITES LTD8854312025-07-08
15060155712045Synicem Hip Spacer 56CBIOCOMPOSITES LTD8854322025-07-08
15060155712052Synicem Hip Spacer 40CXLBIOCOMPOSITES LTD8854332025-07-08
15060155712069Synicem Hip Spacer 48CXLBIOCOMPOSITES LTD8854342025-07-08
15060155712076Synicem Hip Spacer 56CXLBIOCOMPOSITES LTD8854352025-07-08
15060155712083Synicem Hip Spacer 48MBIOCOMPOSITES LTD8854362025-07-08
15060155712090Synicem Hip Spacer 56MBIOCOMPOSITES LTD8854372025-07-08
15060155712120Synicem Knee Spacer R58BIOCOMPOSITES LTD8854382025-07-08
15060155712137Synicem Knee Spacer L58BIOCOMPOSITES LTD8854392025-07-08
15060155712144Synicem Knee Spacer R65BIOCOMPOSITES LTD8854402025-07-08
15060155712151Synicem Knee Spacer L65BIOCOMPOSITES LTD8854412025-07-08
15060155712168Synicem Knee Spacer R72BIOCOMPOSITES LTD8854422025-07-08
15060155712175Synicem Knee Spacer L72BIOCOMPOSITES LTD8854432025-07-08
15060155712182Synicem Knee Spacer R79BIOCOMPOSITES LTD8854442025-07-08
15060155712199Synicem Knee Spacer L79BIOCOMPOSITES LTD8854452025-07-08
15060155712212Synicem Shoulder Spacer 40HBIOCOMPOSITES LTD8854462025-07-08
15060155712229Synicem Shoulder Spacer 48HBIOCOMPOSITES LTD8854472025-07-08
15060155712786Synicem Knee Spacer R65 demoBIOCOMPOSITES LTD8815002025-07-08
15060155712793Synicem Knee Spacer L65 demoBIOCOMPOSITES LTD8815012025-07-08
15060155712809Synicem Hip Spacer 48C demoBIOCOMPOSITES LTD8815022025-07-08
15060155712816Synicem Hip Spacer 48CXL demoBIOCOMPOSITES LTD8815032025-07-08
15060155712823Synicem Hip Spacer 48M demoBIOCOMPOSITES LTD8815042025-07-08
15060155712830Synicem Shoulder Spacer H48 demoBIOCOMPOSITES LTD8815052025-07-08
04260102136694COPAL® exchange GHeraeus Medical GmbHhip S long2019-11-25
04260102136724COPAL® exchange GHeraeus Medical GmbHhip M long2019-11-25
04260102136755COPAL® exchange G Heraeus Medical GmbHhip L long2019-11-25
04260102136786COPAL® exchange GHeraeus Medical GmbHhip XL long2019-11-25
04260102136816COPAL® exchange GHeraeus Medical GmbHhip S short2019-11-25