FDA.reportPublic FDA data

Morphix

Primary DI
M97010000335500
Brand
Morphix
Company
Medshape, Inc.
Model
1000-03-355
Device description
MORPHIX 5.5mm x 11mm Anchor with three sutures
Published
2017-02-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091202000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091202000WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS,Medshape Solutions2009-09-16HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M97010000335500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
601306413
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M97012000112300DynaNail1200-01-12302026-10-16
00190446960300DYNANAIL HELIX3100-13-00012026-10-09
00190446960317Active Adaptive3100-14-00012026-10-09
00190446960324DYNANAIL HELIX3100-15-00012026-10-09
00190446960331DYNANAIL HELIX3100-16-00012026-10-09
00190446960348DYNANAIL HELIX3100-17-00452026-10-09
00190446960355DYNANAIL HELIX3100-18-00012026-10-09
00190446960362DYNANAIL HELIX3100-19-00012026-10-09
00190446960379DYNANAIL HELIX3100-20-00012026-10-09
00190446960386Active Adaptive3100-21-00012026-10-09
00190446960393DYNANAIL HELIX3100-22-00012026-10-09
00190446960409DYNANAIL HELIX3100-17-00552026-10-09
00190446960416DYNANAIL HELIX3100-17-00652026-10-09
00190446907466EF1916-07-00012026-06-25
00190446907473EF1916-07-00022026-06-25
M97015000009200Eclipse1500-00-09202017-02-16
M97015000004100Eclipse1500-00-04102017-05-19
M97015000004170Eclipse1500-00-04172017-02-16
M97015000005120Eclipse1500-00-05122017-05-19
M97015000005200Eclipse1500-00-05202017-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867576032Arthrex®ARTHREX, INC.MBI2026-10-20
00888867576056Arthrex®ARTHREX, INC.MBI2026-10-20
00888867627840Arthrex®ARTHREX, INC.MBI2026-10-07
00888867627857Arthrex®ARTHREX, INC.MBI2026-10-07
00888867627864Arthrex®ARTHREX, INC.MBI2026-10-07
00817337000586Integrity Retractable Implant InserterAnika Therapeutics, Inc.MBI2026-10-05
20845854655501Argo KnotlessConmed CorporationMBI2026-09-25
20845854655518Argo KnotlessConmed CorporationMBI2026-09-25
00889024711280Jgrknt Reusable Fishmouth Perc GuideBiomet Orthopedics, LLCMBI2026-08-25
00889024712034Percutaneous Soft Anchor Short 1.4mm GuideBiomet Orthopedics, LLCMBI2026-08-25
00810198920178TeKBraceTheraMicro, LLCMBI2026-08-14
00811714036472ThunderboltRESPONSIVE ORTHOPEDICS LLCMBI2026-07-31
00811714036489ThunderboltRESPONSIVE ORTHOPEDICS LLCMBI2026-07-31
00810146164340RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164357RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164388RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164418RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164449RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164456RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164463RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164500RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164517RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164531RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164562RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164579RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164623RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164654RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164685RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164692RedifixTRAX SURGICAL INC.MBI2026-07-20
00860016070004ICONN Revolution 6.5MM Knotless Suture AnchorICONN ORTHOPEDICS LLCMBI2026-07-16