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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2012 | Linvatec Corp. dba ConMed Linvatec "***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***
To reattach soft tissue to bone in orthopedic surgical proced Terminated |
MBI | K112965 |
| Aug 9, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile
Part Number: 72202897
Product Usage: intended for use for the
reattachment of soft tissue to bone Terminated |
MBI | K100159 |
| Aug 9, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile
Part Number: 72202896
Product Usage: intended for use for the
reattachment of soft tissue to b Terminated |
MBI | K100159 |
| Aug 9, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile
Part Number: 72202895
Product Usage: intended for use for the
reattachment of soft tissue to bone Terminated |
MBI | K100159 |
| Aug 9, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles
Product Usage: intended for use for the
reattachment of soft tissue to bone
Part Terminated |
MBI | K100159 |
| Jan 11, 2012 | Biomet Sports Medicine Artificial Ligament Fixation Device 15MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 25MM TI NS ToggleLoc (TM) Terminated |
MBI | K033838 |
| Jan 11, 2012 | Innovatech Medical Resources L.P. 5.0 mm Parafix Part Number 22-5011 is a suture anchor metal
Intended for rotator cuff repair. Terminated |
MBI | K042584 |
| Jan 11, 2012 | Innovatech Medical Resources L.P. OPUS SpeedScrew Implant Product Number OM-6500 is a bone anchor
Intended to be used for fixation of soft tissue to bones Terminated |
MBI | K101448 |
| Jan 11, 2012 | Innovatech Medical Resources L.P. OPUS Magnum 2 Plus Implant Product Number OM-9027 is one of two kits with product number OM-1502
Intended for rotator cuff repair Terminated |
MBI | K083240 |
| Jan 11, 2012 | Innovatech Medical Resources L.P. OPUS Magnum 2 Plus Implant Product Number OM-9026 is one of two kits
Intended for rotator cuff repair. Terminated |
MBI | K083240 |
| Jan 11, 2012 | Innovatech Medical Resources L.P. OPUS Magnum 2 Plus Implant Product Number OM-1502 is a bone anchor
Intended for rotator cuff repair in the shoulder. Terminated |
MBI | K083240 |
| Oct 18, 2011 | Wright Medical Technology Inc ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 7.5mm, 2 SUTURE, REF 5100-0020, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002
Product Usage: T Terminated |
MBI | K971282 |
| Oct 18, 2011 | Wright Medical Technology Inc ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 5.0mm, 2 SUTURE, REF 5100-0018, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002
Product Usage: Th Terminated |
MBI | K971282 |
| Oct 18, 2011 | Wright Medical Technology Inc ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 5.0mm, 0 SUTURE, REF 5100-0016, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002
Product Usage: T Terminated |
MBI | K971282 |
| Oct 18, 2011 | Wright Medical Technology Inc ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 3.5mm, 2 SUTURE, REF 5100-0014, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002
Product Usage: T Terminated |
MBI | K971282 |
| Oct 18, 2011 | Wright Medical Technology Inc ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 3.5mm, 0 SUTURE, REF 5100-0012, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002
Product Usage: T Terminated |
MBI | K971282 |
| Oct 18, 2011 | Wright Medical Technology Inc ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 2 SUTURE, REF 5100-0010, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002
Product Usage: T Terminated |
MBI | K971282 |
| Oct 18, 2011 | Wright Medical Technology Inc ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 0 SUTURE, REF 5100-008, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002
Product Usage: Th Terminated |
MBI | K971282 |
| Oct 18, 2011 | Wright Medical Technology Inc ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 2.0 SUTURE, REF 5100-006, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002
Product Usage: T Terminated |
MBI | K971282 |
| Oct 18, 2011 | Wright Medical Technology Inc ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 1.9mm, 0 SUTURE, REF 5100-004,1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002
Product Usage: The Terminated |
MBI | K971282 |
| Oct 18, 2011 | Wright Medical Technology Inc ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 1.9mm, 2.0 SUTURE, REF 5100-002, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002
Product Usage: T Terminated |
MBI | K971282 |
| Aug 31, 2011 | Biomet, Inc. REF 91200, Juggerknot system, Soft Anchors, -Two implants size 1, Biomet Sports Medicine, STERILE.
Product Usage: The JuggerKnot Soft Anchors include various size ranges, each consisting of a cor Terminated |
MBI | K110145 |
| Jun 29, 2011 | Linvatec Corp. dba ConMed Linvatec "***LINVATEC SRS SHOULDER RESTORATION SYSTEM CrossFT 5.5mm CrossFT Suture Anchor with Two#2 (5 metric) Hi-Fi Sutures***SRS.Linvatec.com***ConMed Linvatec Biomaterials, Ltd. Hemiankatu 6-8L 33720 Tampe Terminated |
MBI | None listed |
| May 19, 2011 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek GRYPHON P BR Anchor w/ORTHOCORD
Product Code: 210814
Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio Terminated |
MBI | K090124 |
| May 19, 2011 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek GRYPHON P BR DS Anchor w/ORTHOCORD
Product Code: 210813
Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acrom Terminated |
MBI | K090124 |
| May 19, 2011 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek GRYPHON T BR Anchor w/ORTHOCORD
Product Code: 210812
Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio- Terminated |
MBI | None listed |
| May 19, 2011 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORD
Product Code: 210811
Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acrom Terminated |
MBI | K073412 |
| Apr 12, 2011 | ArthroCare Corporation ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500. Terminated |
MBI | K090615 |
| Mar 4, 2011 | Wright Medical Technology Inc TI ANCHOR 2.5MM W / 2-0 SUTURE, G-FORCE (R) SUTURE ANCHOR, Tissue Anchor, REF 86TA-2520, Rx ONLY, Sterile EO, Wright, Arlington, TN USA
Used in the repair of tendons and ligaments Terminated |
MBI | K100579 |
| Mar 4, 2011 | Wright Medical Technology Inc TI ANCHOR 1.9MM W / 2-0 SUTURE, G-FORCE SUTURE ANCHOR, Tissue Anchor, REF 86TA-1920, Rx ONLY, Sterile EO, Wright, Arlington, TN USA
Used in the repair of tendons and ligaments Terminated |
MBI | K100579 |
| Jul 1, 2010 | Biomet, Inc. Toggleloc Artificial ligament fixation device ZIPLOOP Technology Implant Kit, Sterile, REF 909848, Biomet Sports Medicine Warsaw, IN.
Intended for soft tissue to bone fixation. Terminated |
MBI | K083070 |
| Jul 1, 2010 | Biomet, Inc. Artificial ligament fixation device # 7PE ZIPLOOP Extended Toggle, Sterile, REF 904755, Biomet Sports Medicine Warsaw, IN.
Intended for soft tissue to bone fixation. Terminated |
MBI | K083070 |
| Dec 22, 2009 | Biomet, Inc. Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - SS with Ziploop Technology, polyethylene/polypropylene/ polyester/ stainless steel, sterile Biomet Sports Medicine, Warsaw, IN.; R Terminated |
MBI | K083070 |
| Dec 22, 2009 | Biomet, Inc. Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - Titanium with Ziploop Technology, polyethylene/polypropylene/ polyester/TI-6AL-4V alloy/S.S., sterile Biomet Sports Medicine, Wars Terminated |
MBI | K083070 |
| Sep 4, 2008 | Biomet Sports Medicine BIOMET EZLoc 9-10mm TM Femoral Fixation, Catalog Number 904781. The Ezloc Is indicated for use for fixation of tendons & ligaments during orthopedic reconstruction procedures such as Anterior Crucia Terminated |
MBI | K041261 |
| Sep 4, 2008 | Biomet Sports Medicine BIOMET EZLoc 7-8mm TM Femoral Fixation, Catalog Number 904780. The Ezloc Is indicated for use for fixation of tendons & ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Terminated |
MBI | K041261 |
| Aug 6, 2008 | Stryker Endoscopy Stryker Wedge HS Suture Anchor II with Needles, 6.5 mm, Model number 3910-100-145
Intended for use in securing soft tissue to bone in certain procedures in specific areas. Terminated |
MBI | K983557 |
| Aug 6, 2008 | Stryker Endoscopy Stryker Wedge HS Suture Anchor II with Needles, 5.0 mm, Model number 3910-100-135.
Intended for use in securing soft tissue to bone in certain procedures in specific areas. Terminated |
MBI | K983557 |
| Jul 16, 2008 | American Medical Systems AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System. Terminated |
MBI | K970292 |
| Dec 8, 2007 | Axya Medical Arthrocare 6.5 mm ParaSorb, Preloaded with 2
MagnumWire sutures (1 white/1 co-braid) with needle
Part Number:22-5065N, Axya Medical, Inc., Beverly, MA 01915 Terminated |
MBI | K051983 K052491 +1 |
| Dec 8, 2007 | Axya Medical Arthrocare 6.5 mm ParaSorb, Preloaded with 2
MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5065, Axya Medical, Inc., Beverly, MA 01915 Terminated |
MBI | K051983 K052491 +1 |
| Dec 8, 2007 | Axya Medical Arthrocare 5.5mm ParaSorb, pre-loaded with 2
MagnumWire sutures (1 white/1 co-braid) with needle
Part Number: 22-5055N, Axya Medical, Inc., Beverly, MA 01915 Terminated |
MBI | K051983 K052491 +1 |
| Dec 8, 2007 | Axya Medical Arthrocare 5.5mm ParaSorb, pre-loaded with 2
MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5055 , Axya Medical, Inc., Beverly, MA 01915 Terminated |
MBI | K051983 K052491 +1 |
| Dec 8, 2007 | Axya Medical Arthrocare 3.0mm ParaSorb, Preloaded with 2
MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5030, Axya Medical, Inc., Beverly, MA 01915 Terminated |
MBI | K051983 K052491 +1 |
| Dec 8, 2007 | Axya Medical Arthrocare 6.5mm ParaFix Anchor, 2 strands of MagnumWire
Part Number: 22-5012, Axya Medical, Inc., Beverly, MA 01915 Terminated |
MBI | K051983 K052491 +1 |
| Dec 8, 2007 | Axya Medical Arthrocare 5mm ParaFix Anchor, 2 strands of MagnumWire
Part Number: 22-5011, Axya Medical, Inc., Beverly, MA 01915 Terminated |
MBI | K051983 K052491 +1 |
| Dec 8, 2007 | Axya Medical Arthrocare 3mm ParaFix Anchor, single strand of Magnum Wire,Part Number: 22-5010, Axya Medical, Inc., Beverly, MA 01915 Terminated |
MBI | K051983 K052491 +1 |
| Dec 8, 2007 | Axya Medical Arthocare 3mm ParaFix Anchor (3mm x 9mm) -single strand of #2 braided suture,Part Number: 22-5002, Axya Medical, Inc., Beverly, MA 01915 Terminated |
MBI | K051983 K052491 +1 |
| Dec 8, 2007 | Axya Medical Arthocare 5mm ParaFix Anchor (5mm x 14.5mm) -2 strands of #2 braided suture, Part Number: 22-5001, Axya Medical, Inc., Beverly, MA 01915 Terminated |
MBI | K051983 K052491 +1 |
| Dec 8, 2007 | Axya Medical Axya Bone Anchor 3.0 mm Bioabsorbable in Super Kit
Catalog Number: CAT1273, Axya Medical, Inc., Beverly, MA 01915 Terminated |
MBI | None listed |
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