Panels › Orthopedic › Product code MBI · Class 2
Fastener, Fixation, Nondegradable, Soft Tissue
Regulation 888.3040
32510(k)s in 12 months (606 all time)
0recalls in 12 months (113 all time)
104recalls that name a 510(k)
Top companies in MBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Arthrex, Inc. | 52 | 1 |
| ArthroCare Corporation | 31 | 1 |
| Axya Medical, Inc. | 5 | 24 |
| Smith & Nephew | 23 | 5 |
| Riverpoint Medical | 23 | 1 |
| Parcus Medical | 23 | 0 |
| Innovasive Devices, Inc. | 22 | 0 |
| Biomet, Inc. | 10 | 10 |
| CONMED Corporation | 16 | 1 |
| Stryker | 10 | 6 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 24, 2011 | K110545 | SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK) Smith & Nephew, Inc. | MBI |
| Jun 16, 2011 | K111564 | MAXFIRE MARXMEN MENISCAL REPAIR DEVICE Biomet Sports Medicine | MBI |
| Jun 10, 2011 | K111471 | EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) Medshape Solutions, Inc. | MBI |
| Jun 2, 2011 | K110773 | TORNIER INSITE FT SUTURE ANCHOR Tornier, Inc. | MBI |
| May 27, 2011 | K110781 | 5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP Arthrocare Corp. | MBI |
| May 25, 2011 | K110473 | NANOTACK SUTURE ANCHOR 1.4MM Pivot Medical | MBI |
| May 19, 2011 | K110230 | ROG KNOTLESS SUTURE ANCHOR Rog Sports Medicine, Inc. | MBI |
| May 18, 2011 | K110229 | ROG SUTURE ANCHOR 5.5MM, 2.9MM Rog Sports Medicine, Inc. | MBI |
| Apr 5, 2011 | K103262 | QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM Tornier, Inc. | MBI |
| Mar 4, 2011 | K110145 | BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR Biomet, Inc. | MBI |
| Feb 24, 2011 | K102539 | ICUFF REPAIR PLATE, RIGHT; CUFF REPAIR PLATE. LEFT; ANCHOR BOLT, 10MM THROUGH 50MM Shoulder Options, Inc. | MBI |
| Feb 9, 2011 | K103145 | HAMMERLOC TM TIBIAL FIXATION DEVICE Biomet Sports Medicine | MBI |
| Feb 7, 2011 | K110164 | 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL Arthrocare Corp. | MBI |
| Jan 6, 2011 | K101616 | THE GRAPPLR AND GRAPPLR EXTENDER Tag Medical Corp. | MBI |
| Jan 5, 2011 | K103060 | ARTHREX TIBIAL GRAFTBOLT Arthrex, Inc. | MBI |
| Dec 13, 2010 | K102660 | BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS Smith & Nephew Endoscopy, Inc. | MBI |
| Dec 2, 2010 | K101126 | PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS Core Essence Orthopaedics, Inc. | MBI |
| Oct 29, 2010 | K101437 | SPEEDFIX SUTURE SYSTEM Arthrocare Corp. | MBI |
| Oct 21, 2010 | K102262 | ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL Arthrocare Corp. | MBI |
| Oct 20, 2010 | K102443 | INTRAFIX TIBIAL SHEATH Depuy Mitek, A Johnson & Johnson Company | MBI |
| Jun 23, 2010 | K101063 | SLEEVE WITH ZIPLOOP FIXATION DEVICES Biomet Sports Medicine | MBI |
| Jun 21, 2010 | K101448 | OPUS SPEEDSCREW SYSTEM Arthrocare Corp. | MBI |
| Jun 11, 2010 | K100630 | G-FORCE PEEK SUTURE ANCHOR SYSTEM Wrightmedicaltechnologyinc | MBI |
| May 20, 2010 | K101175 | KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER Kfx Medical | MBI |
| May 18, 2010 | K101184 | TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006 Arthrocare Corp. | MBI |
| Apr 19, 2010 | K100159 | SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR Smith & Nephew Inc., Endoscopy Div. | MBI |
| Apr 5, 2010 | K093935 | SMITH & NEPHEW FOOTPRINT RCX PK SUTURE ANCHOR Smith & Nephew, Inc. | MBI |
| Mar 26, 2010 | K100579 | G-FORCE TI SUTURE ANCHOR SYSTEM Wrightmedicaltechnologyinc | MBI |
| Mar 18, 2010 | K093912 | ARTHREX TIBIAL GRAFTBOLT Arthrex, Inc. | MBI |
| Mar 5, 2010 | K093943 | BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM Smith & Nephew Inc., Endoscopy Div. | MBI |
| Mar 4, 2010 | K093897 | SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR Smith & Nephew Inc., Endoscopy Div. | MBI |
| Feb 4, 2010 | K092836 | OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141 Depuy Mitek, A Johnson & Johnson Company | MBI |
| Dec 23, 2009 | K092998 | CONMED LINVATEC INTERCEPT IMPLANT Linvatec Corp. | MBI |
| Dec 17, 2009 | K093428 | SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR Smith & Nephew Endoscopy, Inc. | MBI |
| Dec 15, 2009 | K093228 | SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR Smith & Nephew, Inc. | MBI |
| Dec 9, 2009 | K092914 | WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES Medshape Solutions | MBI |
| Sep 30, 2009 | K091094 | PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264 Parcus Medical, LLC | MBI |
| Sep 21, 2009 | K091870 | TORNIER, PITON FIXATION IMPLANT SYSTEM Tornier | MBI |
| Jun 30, 2009 | K090923 | PARCUS GRAFT FIXATION SYSTEM Parcus Medical, LLC | MBI |
| Jun 23, 2009 | K091549 | CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM Linvatec Corp. | MBI |
| Jun 17, 2009 | K091503 | MAGNUM MP FIXATION DEVICE Arthrocare Corp. | MBI |
| Jun 3, 2009 | K090615 | OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE Arthrocare Corp. | MBI |
| May 20, 2009 | K090530 | SPIN-LOC SUTURE ANCHOR SYSTEM FG-0302-01,FG-0305-01 Ross Creek Medical, Inc. | MBI |
| Mar 13, 2009 | K090380 | MAGNUM M FIXATION DEVICE Arthrocare Corp. | MBI |
| Mar 6, 2009 | K090075 | PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258 Parcus Medical, LLC | MBI |
| Mar 6, 2009 | K083609 | KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE Kfx Medical | MBI |
| Jan 30, 2009 | K083635 | SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW Smith & Nephew Endoscopy, Inc. | MBI |
| Jan 30, 2009 | K083226 | SMITH & NEPHEW PEEK INTERFERENCE SCREW Smith & Nephew Endoscopy, Inc. | MBI |
| Jan 22, 2009 | K083151 | EXTREMITY MEDICAL SUTURE ANCHOR Extremity Medical, LLC | MBI |
| Jan 15, 2009 | K083150 | G-FORCE TENODESIS SCREW Wrightmedicaltechnologyinc | MBI |
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