510(k) Report

Devices descending from K980483

297 later devices reach Mentor Suspend Sling through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+6K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+6K242187BioBrace®Conmed Corporation20241—
+6K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+6K232204ReyaGel (RG03 - MTP gel 3mL)Fettech20240—
+6K231325Corplex P / Theracor P / Allacor PStimlabs, LLC20243—
+6K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+6K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+6K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+6K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+6K222189SiOxD Wound MatrixSioxmed, LLC20222—
+6K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+6K193583Restrata®Acera Surgical, Inc.202011
+6K200413SymphonyAroa Biosurgery, Ltd.20202—
+6K192389TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc.20202—
+6K190528MariGen Wound ExtraKerecis Limited20193—
+6K182169AdVance XP Male SlingBoston Scientific Corporation20182—
+6K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+6K181330NeoMatriX Wound MatrixNextgen Biologics, Inc.20181—
+6K173223ologen Collagen MatrixAeon Astron Europe B.V.20180—
+6K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation201714
+6K162348ABCcolla Collagen MatrixAcro Biomedical Co., Ltd.20171—
+6K153364Kerecis SecureMeshKerecis Limited20160—
+6K152721Cytal Wound MatrixAcell, Inc.201565
+6K152678TYRX Neuro Antibacterial EnvelopeTyrx, Inc.20150—
+6K150291TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.20153—
+6K140116Restorelle Y Contour MeshColoplast A/S20141—
+6K130059Endofast Reliant SCP, Endofast Reliant LapIbi Israel Biomedical Innovations, Ltd.20130—
+6K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+6K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+6K101462Ascend Blue AC Mesh; Ascend Blue PC MeshCaldera Medical, Inc.20106—
+6K100984Xylos Vessel GuardXylos Corporation20100—
+6K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+6K083499Exair Anterior and Posterior Prolapse Repair SystemsColoplast A/S20091—
+6K083898SurgimendTei Biosciences, Inc.200993
+6K082640Virtue Ventral Urethral Elevation Sling SystemColoplast Manufacturing Us, LLC20085—
+6K082216TBD Ethicon MeshETHICON, Inc.20081—
+6K081048Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp200861
+6K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+7K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+7K253204CatalyzeBioTissue Holdings, Inc.20260—
+7K260317Artelon Convenience KitsInternational Life Sciences20260—
+7K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+7K252673LacertaMatrixLacerta Life Science20251—
+7K253339TheracorStimlabs, LLC20250—
+7K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+7K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+7K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+7K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+7K250395BioBrace ® RC Delivery SystemConmed Corporation20250—
+7K233378ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd.20240—
+7K242828Corplex P/ Theracor P/ Allacor PStimlabs, LLC20240—
+7K241080Kerecis Parvus (50207)Kerecis Limited20241—
+7K241724Cytal® Wound Matrix; Cytal® Burn MatrixAcell, Inc.20240—
+7K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+7K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.20241—
+7K232847SiOxD Wound MatrixSioxmed, LLC20231—
+7K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+7K213231Kerecis SiliconeKerecis Limited20221—
+7K213607Geistlich Wound Matrix PLUSGeistlich Pharma AG20220—
+7K211847AdVance XP Male Sling SystemBoston Scientific Corporation20211—
+7K210024NeoMatriX Wound MatrixNextgen Biologics, Inc.20210—
+7K192725Cytal Wound Matrix 3-LayerAcell, Inc.20191—
+7K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+7K180122TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable…Medtronic, Inc.20181—
+7K180776Cytal Wound ParticulateAcell, Inc.20180—
+7K173527Digitex Delivery DeviceColoplast A/S20180—
+7K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—
+7K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702
+7K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+7K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+7K123128Seri Surgical ScaffoldAllergan20135—
+7K120327VertessaCaldera Medical, Inc.20125—
+7K112386Exair Anterior and Posterior Prolapse Repair SystemColoplast Corp.20110—
+7K101297Virtue Ventral Urethral Elevation Sling System Model 50020Coloplast A/S20103—
+7K091131Pelvic Floor Repair SystemBoston Scientific20095—
+7K091152Virtue Ventral Urethral Elevation Sling System, Model 50020Coloplast A/S20094—
+7K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+8K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+8K262406EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific20260—
+8K260218LacertaMatrixLacerta Life Sciences20260—
+8K242960AdVance™ XP Male Sling System (720163-03)Boston Scientific Corporation20240—
+8K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—
+8K192636TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable…Medtronic, Inc.20200—
+8K172545SERI ContourSofregen Medical, Inc.20170—
+8K140533Galaflex MeshTepha, Inc.20143—
+8K123337Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMCaldera Medical20131—
+8K122968Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015Coloplast Corp.20120—
+8K122440Restorelle LColoplast Corp.201211
+8K113496Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S20121—
+8K111881Virtue Male Sling System and Alexis (R) Wound Retractor KitColoplast A/S20110—
+9K231891Virtue Male Sling System with Alexis Wound Retractor Convenience KitColoplast20230—
+9K202425SurgiLattice scaffoldTepha, Inc.20210—
+9K162922GalaFORM 3DTepha, Inc.20170—
+9K161092GalaSHAPE 3DTepha, Inc.201611
+9K150016Vertessa LiteCaldera Medical, Inc.20150—
+9K132061Restorelle M, Restorelle XLColoplast Corp.20130—