FDA.reportPublic FDA data

Temporary knee prosthesis, non-customized

Definition
A prefabricated, implantable device that includes a pharmaceutical antibiotic agent (e.g., gentamicin) intended to be used as a temporary substitute for a knee prosthesis to: 1) provide a means for limited mobility/weight-bearing; and 2) release the antibiotic agent to the periprosthetic space to treat infection as part of a revision orthopaedic surgery. Also known as a spacer, it may include knee femur and/or tibial components, and is made of metallic and/or polymer materials. Following infection treatment and device explantation, a definitive prosthesis is implanted.
GUDID devices
300
Last updated
2025-09-03 16:01:36

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
09348215147501Rx Knee Femoral Cone Augment Size SmallSIGNATURE ORTHOPAEDICS PTY LTD121-25-04002025-08-26
09348215147518Rx Knee Femoral Cone Augment Size MediumSIGNATURE ORTHOPAEDICS PTY LTD121-25-04012025-08-26
09348215147525Rx Knee Femoral Cone Augment Size LargeSIGNATURE ORTHOPAEDICS PTY LTD121-25-04022025-08-26
09348215147532Rx Knee Femoral Cone Augment Size StackableSIGNATURE ORTHOPAEDICS PTY LTD121-25-04032025-08-26
09348215147549Rx Knee Tibial Cone Augment Size SmallSIGNATURE ORTHOPAEDICS PTY LTD121-25-04042025-08-26
09348215147556Rx Knee Tibial Cone Augment Size LargeSIGNATURE ORTHOPAEDICS PTY LTD121-25-04052025-08-26
09348215147563Rx Knee Tibial Cone Augment Size StackableSIGNATURE ORTHOPAEDICS PTY LTD121-25-04062025-08-26
09348215110420Rx Knee AP Symmetrical Augment Size 1 - 12mm Poly DraftSIGNATURE ORTHOPAEDICS PTY LTD121-20-91812025-03-19
09348215110437Rx Knee AP Symmetrical Augment Size 2 - 12mm Poly DraftSIGNATURE ORTHOPAEDICS PTY LTD121-20-91822025-03-19
09348215110444Rx Knee AP Symmetrical Augment Size 3 - 12mm Poly DraftSIGNATURE ORTHOPAEDICS PTY LTD121-20-91832025-03-19
09348215110451Rx Knee AP Symmetrical Augment Size 4 - 12mm Poly DraftSIGNATURE ORTHOPAEDICS PTY LTD121-20-91842025-03-19
09348215110468Rx Knee AP Symmetrical Augment Size 5 - 12mm Poly DraftSIGNATURE ORTHOPAEDICS PTY LTD121-20-91852025-03-19
09348215110475Rx Knee AP Symmetrical Augment Size 6 - 12mm Poly DraftSIGNATURE ORTHOPAEDICS PTY LTD121-20-91862025-03-19
09348215110482Rx Knee AP Symmetrical Augment Size 7 - 12mm Poly DraftSIGNATURE ORTHOPAEDICS PTY LTD121-20-91872025-03-19
09348215110499Rx Knee AP Symmetrical Augment Size 8 - 12mm Poly DraftSIGNATURE ORTHOPAEDICS PTY LTD121-20-91882025-03-19
09348215110505Rx Knee AP Symmetrical Augment Size 9 - 12mm Poly DraftSIGNATURE ORTHOPAEDICS PTY LTD121-20-91892025-03-19
09348215110697Rx Knee AP Symmetrical Augment Size 1 - 12mm Poly Half Draft RightSIGNATURE ORTHOPAEDICS PTY LTD121-20-92112025-03-19
09348215110703Rx Knee AP Symmetrical Augment Size 2 - 12mm Poly Half Draft RightSIGNATURE ORTHOPAEDICS PTY LTD121-20-92122025-03-19
09348215110710Rx Knee AP Symmetrical Augment Size 3 - 12mm Poly Half Draft RightSIGNATURE ORTHOPAEDICS PTY LTD121-20-92132025-03-19
09348215110727Rx Knee AP Symmetrical Augment Size 4 - 12mm Poly Half Draft RightSIGNATURE ORTHOPAEDICS PTY LTD121-20-92142025-03-19
09348215110734Rx Knee AP Symmetrical Augment Size 5 - 12mm Poly Half Draft RightSIGNATURE ORTHOPAEDICS PTY LTD121-20-92152025-03-19
09348215110741Rx Knee AP Symmetrical Augment Size 6 - 12mm Poly Half Draft RightSIGNATURE ORTHOPAEDICS PTY LTD121-20-92162025-03-19
09348215110758Rx Knee AP Symmetrical Augment Size 7 - 12mm Poly Half Draft RightSIGNATURE ORTHOPAEDICS PTY LTD121-20-92172025-03-19
09348215110765Rx Knee AP Symmetrical Augment Size 8 - 12mm Poly Half Draft RightSIGNATURE ORTHOPAEDICS PTY LTD121-20-92182025-03-19
09348215110772Rx Knee AP Symmetrical Augment Size 9 - 12mm Poly Half Draft RightSIGNATURE ORTHOPAEDICS PTY LTD121-20-92192025-03-19
09348215111458Rx Knee AP Symmetrical Augment Size 1 - 12mm Titanium DraftSIGNATURE ORTHOPAEDICS PTY LTD121-20-92612025-03-19
09348215111465Rx Knee AP Symmetrical Augment Size 2 - 12mm Titanium DraftSIGNATURE ORTHOPAEDICS PTY LTD121-20-92622025-03-19
09348215111472Rx Knee AP Symmetrical Augment Size 3 - 12mm Titanium DraftSIGNATURE ORTHOPAEDICS PTY LTD121-20-92632025-03-19
09348215111489Rx Knee AP Symmetrical Augment Size 4 - 12mm Titanium DraftSIGNATURE ORTHOPAEDICS PTY LTD121-20-92642025-03-19
09348215111496Rx Knee AP Symmetrical Augment Size 5 - 12mm Titanium DraftSIGNATURE ORTHOPAEDICS PTY LTD121-20-92652025-03-19
09348215111502Rx Knee AP Symmetrical Augment Size 6 - 12mm Titanium DraftSIGNATURE ORTHOPAEDICS PTY LTD121-20-92662025-03-19
09348215111519Rx Knee AP Symmetrical Augment Size 7 - 12mm Titanium DraftSIGNATURE ORTHOPAEDICS PTY LTD121-20-92672025-03-19
09348215111526Rx Knee AP Symmetrical Augment Size 8 - 12mm Titanium DraftSIGNATURE ORTHOPAEDICS PTY LTD121-20-92682025-03-19
09348215111533Rx Knee AP Symmetrical Augment Size 9 - 12mm Titanium DraftSIGNATURE ORTHOPAEDICS PTY LTD121-20-92692025-03-19
09348215111724Rx Knee AP Symmetrical Augment Size 1 - 12mm Titanium Half Draft RightSIGNATURE ORTHOPAEDICS PTY LTD121-20-92912025-03-19
09348215111731Rx Knee AP Symmetrical Augment Size 2 - 12mm Titanium Half Draft RightSIGNATURE ORTHOPAEDICS PTY LTD121-20-92922025-03-19
09348215111748Rx Knee AP Symmetrical Augment Size 3 - 12mm Titanium Half Draft RightSIGNATURE ORTHOPAEDICS PTY LTD121-20-92932025-03-19
09348215111755Rx Knee AP Symmetrical Augment Size 4 - 12mm Titanium Half Draft RightSIGNATURE ORTHOPAEDICS PTY LTD121-20-92942025-03-19
09348215111762Rx Knee AP Symmetrical Augment Size 5 - 12mm Titanium Half Draft RightSIGNATURE ORTHOPAEDICS PTY LTD121-20-92952025-03-19
09348215111779Rx Knee AP Symmetrical Augment Size 6 - 12mm Titanium Half Draft RightSIGNATURE ORTHOPAEDICS PTY LTD121-20-92962025-03-19
09348215111786Rx Knee AP Symmetrical Augment Size 7 - 12mm Titanium Half Draft RightSIGNATURE ORTHOPAEDICS PTY LTD121-20-92972025-03-19
09348215111793Rx Knee AP Symmetrical Augment Size 8 - 12mm Titanium Half Draft RightSIGNATURE ORTHOPAEDICS PTY LTD121-20-92982025-03-19
09348215111809Rx Knee AP Symmetrical Augment Size 9 - 12mm Titanium Half Draft RightSIGNATURE ORTHOPAEDICS PTY LTD121-20-92992025-03-19
09348215146603Rx Knee AP Symmetrical Augment Size 1 - 8mm Poly HalfSIGNATURE ORTHOPAEDICS PTY LTD121-20-93412025-03-19
09348215146610Rx Knee AP Symmetrical Augment Size 2 - 8mm Poly HalfSIGNATURE ORTHOPAEDICS PTY LTD121-20-93422025-03-19
09348215146627Rx Knee AP Symmetrical Augment Size 3 - 8mm Poly HalfSIGNATURE ORTHOPAEDICS PTY LTD121-20-93432025-03-19
09348215146634Rx Knee AP Symmetrical Augment Size 4 - 8mm Poly HalfSIGNATURE ORTHOPAEDICS PTY LTD121-20-93442025-03-19
09348215146641Rx Knee AP Symmetrical Augment Size 5 - 8mm Poly HalfSIGNATURE ORTHOPAEDICS PTY LTD121-20-93452025-03-19
09348215146658Rx Knee AP Symmetrical Augment Size 6 - 8mm Poly HalfSIGNATURE ORTHOPAEDICS PTY LTD121-20-93462025-03-19
09348215146665Rx Knee AP Symmetrical Augment Size 7 - 8mm Poly HalfSIGNATURE ORTHOPAEDICS PTY LTD121-20-93472025-03-19
09348215146672Rx Knee AP Symmetrical Augment Size 8 - 8mm Poly HalfSIGNATURE ORTHOPAEDICS PTY LTD121-20-93482025-03-19
09348215146689Rx Knee AP Symmetrical Augment Size 9 - 8mm Poly HalfSIGNATURE ORTHOPAEDICS PTY LTD121-20-93492025-03-19
09348215146696Rx Knee AP Symmetrical Augment Size 1 - 8mm Poly Half Draft LeftSIGNATURE ORTHOPAEDICS PTY LTD121-20-93512025-03-19
09348215146702Rx Knee AP Symmetrical Augment Size 2 - 8mm Poly Half Draft LeftSIGNATURE ORTHOPAEDICS PTY LTD121-20-93522025-03-19
09348215146719Rx Knee AP Symmetrical Augment Size 3 - 8mm Poly Half Draft LeftSIGNATURE ORTHOPAEDICS PTY LTD121-20-93532025-03-19
09348215146726Rx Knee AP Symmetrical Augment Size 4 - 8mm Poly Half Draft LeftSIGNATURE ORTHOPAEDICS PTY LTD121-20-93542025-03-19
09348215146733Rx Knee AP Symmetrical Augment Size 5 - 8mm Poly Half Draft LeftSIGNATURE ORTHOPAEDICS PTY LTD121-20-93552025-03-19
09348215146740Rx Knee AP Symmetrical Augment Size 6 - 8mm Poly Half Draft LeftSIGNATURE ORTHOPAEDICS PTY LTD121-20-93562025-03-19
09348215146757Rx Knee AP Symmetrical Augment Size 7 - 8mm Poly Half Draft LeftSIGNATURE ORTHOPAEDICS PTY LTD121-20-93572025-03-19
09348215146764Rx Knee AP Symmetrical Augment Size 8 - 8mm Poly Half Draft LeftSIGNATURE ORTHOPAEDICS PTY LTD121-20-93582025-03-19
09348215146771Rx Knee AP Symmetrical Augment Size 9 - 8mm Poly Half Draft LeftSIGNATURE ORTHOPAEDICS PTY LTD121-20-93592025-03-19
09348215146788Rx Knee AP Symmetrical Augment Size 1 - 12mm Poly HalfSIGNATURE ORTHOPAEDICS PTY LTD121-20-93612025-03-19
09348215146795Rx Knee AP Symmetrical Augment Size 2 - 12mm Poly HalfSIGNATURE ORTHOPAEDICS PTY LTD121-20-93622025-03-19
09348215146801Rx Knee AP Symmetrical Augment Size 3 - 12mm Poly HalfSIGNATURE ORTHOPAEDICS PTY LTD121-20-93632025-03-19
09348215146818Rx Knee AP Symmetrical Augment Size 4 - 12mm Poly HalfSIGNATURE ORTHOPAEDICS PTY LTD121-20-93642025-03-19
09348215146825Rx Knee AP Symmetrical Augment Size 5 - 12mm Poly HalfSIGNATURE ORTHOPAEDICS PTY LTD121-20-93652025-03-19
09348215146832Rx Knee AP Symmetrical Augment Size 6 - 12mm Poly HalfSIGNATURE ORTHOPAEDICS PTY LTD121-20-93662025-03-19
09348215146849Rx Knee AP Symmetrical Augment Size 7 - 12mm Poly HalfSIGNATURE ORTHOPAEDICS PTY LTD121-20-93672025-03-19
09348215146856Rx Knee AP Symmetrical Augment Size 8 - 12mm Poly HalfSIGNATURE ORTHOPAEDICS PTY LTD121-20-93682025-03-19
09348215146863Rx Knee AP Symmetrical Augment Size 9 - 12mm Poly HalfSIGNATURE ORTHOPAEDICS PTY LTD121-20-93692025-03-19
09348215146870Rx Knee AP Symmetrical Augment Size 1 - 12mm Poly Half Draft Left SIGNATURE ORTHOPAEDICS PTY LTD121-20-93712025-03-19
09348215146887Rx Knee AP Symmetrical Augment Size 2 - 12mm Poly Half Draft LeftSIGNATURE ORTHOPAEDICS PTY LTD121-20-93722025-03-19
09348215146894Rx Knee AP Symmetrical Augment Size 3 - 12mm Poly Half Draft LeftSIGNATURE ORTHOPAEDICS PTY LTD121-20-93732025-03-19
09348215146900Rx Knee AP Symmetrical Augment Size 4 - 12mm Poly Half Draft LeftSIGNATURE ORTHOPAEDICS PTY LTD121-20-93742025-03-19
09348215146917Rx Knee AP Symmetrical Augment Size 5 - 12mm Poly Half Draft LeftSIGNATURE ORTHOPAEDICS PTY LTD121-20-93752025-03-19
09348215146924Rx Knee AP Symmetrical Augment Size 6 - 12mm Poly Half Draft LeftSIGNATURE ORTHOPAEDICS PTY LTD121-20-93762025-03-19
09348215146931Rx Knee AP Symmetrical Augment Size 7 - 12mm Poly Half Draft LeftSIGNATURE ORTHOPAEDICS PTY LTD121-20-93772025-03-19
09348215146948Rx Knee AP Symmetrical Augment Size 8 - 12mm Poly Half Draft LeftSIGNATURE ORTHOPAEDICS PTY LTD121-20-93782025-03-19
09348215146955Rx Knee AP Symmetrical Augment Size 9 - 12mm Poly Half Draft LeftSIGNATURE ORTHOPAEDICS PTY LTD121-20-93792025-03-19
09348215146962Rx Knee AP Symmetrical Augment Size 1 - 8mm Titanium HalfSIGNATURE ORTHOPAEDICS PTY LTD121-20-94612025-03-19