DePuy Mitek, Inc.
Raynham, MA, US
DePuy Mitek, Inc. appears in FDA device records in Raynham, MA. FDA records list 80 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 92 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to DePuy Mitek, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Depuy Mitek, A Johnson and Johnson Company510(k), recall
- Depuy Mitek, Inc., A Johnson and Johnson Company510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 80FDA records hold 80 510(k) clearances for DePuy Mitek, Inc. between 2004 and 2026. The busiest year on record is 2004, with 13. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 13 |
| 2005 | 4 |
| 2006 | 6 |
| 2007 | 3 |
| 2008 | 6 |
| 2009 | 3 |
| 2010 | 5 |
| 2011 | 6 |
| 2012 | 8 |
| 2013 | 12 |
| 2014 | 6 |
| 2015 | 3 |
| 2024 | 3 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253791 | PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid | KCT | Substantially Equivalent | |
| K243790 | GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor | MAI | Substantially Equivalent | |
| K241010 | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors | MAI | Substantially Equivalent | |
| K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw | MAI | Substantially Equivalent | |
| K233675 | FMS VUE™ Fluid Management and Tissue Debridement System | HRX | Substantially Equivalent | |
| K150209 | Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop Anc | MAI | Substantially Equivalent | |
| K143660 | Milagro / Milagro Advance Interference Screw | MAI | Substantially Equivalent | |
| K143475 | VAPR Tripolar Suction Electrode | GEI | Substantially Equivalent | |
| K142574 | 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, | MBI | Substantially Equivalent | |
| K140896 | VAPR ARCTIC SUCTION ELECTRODE | GEI | Substantially Equivalent | |
| K140643 | GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY | MAI | Substantially Equivalent | |
| K140324 | RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL | MBI | Substantially Equivalent | |
| K141259 | GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEK | MAI | Substantially Equivalent | |
| K133794 | 4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 | MAI | Substantially Equivalent | |
| K132241 | GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T | MAI | Substantially Equivalent | |
| K130814 | RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM | MBI | Substantially Equivalent | |
| K131974 | HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) | MAI | Substantially Equivalent | |
| K131191 | 4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS | HRX | Substantially Equivalent | |
| K131683 | HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) | MBI | Substantially Equivalent | |
| K130912 | OMNICUT RESECTION BLADE | HRX | Substantially Equivalent | |
| K130917 | HEALIX ADVANCE KNOTLESS BR ANCHOR | MAI | Substantially Equivalent | |
| K130539 | HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM) | MBI | Substantially Equivalent | |
| K130105 | RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM | HTY | Substantially Equivalent | |
| K130169 | FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE | HRX | Substantially Equivalent | |
| K123668 | ORTHOCORD | NEW | Substantially Equivalent | |
| K123362 | MILAGRO ADVANCE INTERFERENCE SCREW | HWC | Substantially Equivalent | |
| K122869 | MILAGRO INTERFERENCE SCREWS | MAI | Substantially Equivalent | |
| K122425 | VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT | GEI | Substantially Equivalent | |
| K122123 | 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED | MBI | Substantially Equivalent | |
| K120449 | HEALIX ADVANCE PEEK ANCHOR | HWC | Substantially Equivalent | |
| K120589 | MILAGRO INTERFERENCE SCREWS | MAI | Substantially Equivalent | |
| K120095 | SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND | GEI | Substantially Equivalent | |
| K113545 | VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN | GEI | Substantially Equivalent | |
| K112417 | VARIOUS | MBI | Substantially Equivalent | |
| K113534 | HEALIX KNOTLESS ANCHOR | MAI | Substantially Equivalent | |
| K112249 | HEALIX KNOTLESS(TM) ANCHOR | MAI | Substantially Equivalent | |
| K111631 | GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN.. | MBI | Substantially Equivalent | |
| K103831 | DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809 | MAI | Substantially Equivalent | |
| K103712 | GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD | HWC | Substantially Equivalent | |
| K102298 | TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND | HWC | Substantially Equivalent | |
| K102443 | INTRAFIX TIBIAL SHEATH | MBI | Substantially Equivalent | |
| K100638 | VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214 | GEI | Substantially Equivalent | |
| K100012 | GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR A | MAI | Substantially Equivalent | |
| K100532 | VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 | HWC | Substantially Equivalent | |
| K092836 | OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141 | MBI | Substantially Equivalent | |
| K091041 | RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS | MAI | Substantially Equivalent | |
| K090669 | RIGIDFIX BIOCRYL CROSS PIN KITS | MAI | Substantially Equivalent | |
| K090124 | GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814 | MAI | Substantially Equivalent | |
| K082643 | 3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE | GEI | Substantially Equivalent | |
| K082282 | HEALIX TI ANCHOR | HWC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1221934 | 1221934 | DePuy Mitek, Inc. | 325 Paramount Dr, RAYNHAM, MA 02767 US | 2026 | and 72 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)
- GEFApplier, Staple, Surgical,
- HRXArthroscope
- HWJAwl
- HTWBit, Drill
- GFGBit, Surgical
- HTQBroach
- FWFCamera, Television, Endoscopic, Without Audio
- GEACannula, Surgical, General & Plastic Surgery
- JCYCatheter, Infusion
- FZOChisel, Surgical, Manual
- HXDClamp
- FZTCutter, Surgical
- HNXDepressor, Orbital
- HWRDriver, Prosthesis
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GEGElevator, Surgical, General & Plastic Surgery
- HWBExtractor
- GENForceps, General & Plastic Surgery
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- HWAImpactor
- HTZInstrument, Cutting, Orthopedic
- HCFInstrument, Ligature Passing And Knot Tying
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- HTSKnife, Orthopedic
- GCJLaparoscope, General & Plastic Surgery
- FCWLight Source, Fiberoptic, Routine
- FSXLight, Surgical, Connector
- FSTLight, Surgical, Fiberoptic
- GFJMallet, Surgical, General & Plastic Surgery
- FTLMesh, Surgical, Polymeric
- EOBNasopharyngoscope (Flexible Or Rigid)
- GABNeedle, Suturing, Disposable
- HWMOsteotome
- HTYPin, Fixation, Smooth
- HXBProbe
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- JDBProsthesis, Elbow, Semi-Constrained, Cemented
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- HTRRasp
- HTOReamer
- FDCResectoscope, Working Element
- GADRetractor
- HTXRongeur
- GDXScalpel, One-Piece
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- FOXStand, Infusion
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
- GASSuture, Nonabsorbable, Synthetic, Polyester
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- HXGTamp
- HWXTap, Bone
- HWTTemplate
- FSMTray, Surgical, Instrument
- HWKTrephine
- HTNWasher, Bolt Nut
- HXCWrench
Recall records
Showing 25 of 92| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1315-2025 | COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System. | Device is missing the pin in the graft loader component. | Class II | Open, Classified | |
| Z-1314-2025 | COR Disposable Kit, 8 mm. Cartilage Transplant System. | Device is missing the pin in the graft loader component. | Class II | Open, Classified | |
| Z-1681-2023 | DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723 | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time | Class II | Open, Classified | |
| Z-1680-2023 | DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722 | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time | Class II | Open, Classified | |
| Z-1679-2023 | DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726 | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time | Class II | Open, Classified | |
| Z-1678-2023 | DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725 | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time | Class II | Open, Classified | |
| Z-1677-2023 | DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724 | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time | Class II | Open, Classified | |
| Z-0666-2020 | Healix Knotless ADV BR 5.5 Suture Anchor | Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation. | Class II | Terminated | |
| Z-0665-2020 | Healix Knotless ADV BR 4.75 Suture Anchor | Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation. | Class II | Terminated | |
| Z-0208-2019 | Mitek Screw and Washer Depth Gauge, Product Code 219024 | The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole. | Class II | Terminated | |
| Z-1749-2018 | LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the orthopedic surgeon with a means of bone fixation and to assist in the management of reconstructive surgeries. | Reports of product loosening or coming unscrewed from the handle. | Class II | Terminated | |
| Z-0695-2018 | 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures. | Leakage of FMS gravity tub sets (281113) at the bulb and tube connection | Class II | Terminated | |
| Z-2619-2017 | DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw | Class II | Terminated | |
| Z-2618-2017 | DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw | Class II | Terminated | |
| Z-2617-2017 | DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw | Class II | Terminated | |
| Z-2616-2017 | DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw | Class II | Terminated | |
| Z-2615-2017 | DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw | Class II | Terminated | |
| Z-0479-2016 | VAPR TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028) | Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. The wiring for each button function was confirmed as correct and the non-conformance impacted button color only | Class II | Terminated | |
| Z-0658-2016 | FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures. | Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label. | Class II | Terminated | |
| Z-0657-2016 | FMS neXtra 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures. | Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label. | Class II | Terminated | |
| Z-0656-2016 | FMS neXtra 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures. | Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label. | Class II | Terminated | |
| Z-0192-2014 | DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Outflow Tubing with One-Way valve is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy. | Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination | Class II | Terminated | |
| Z-0191-2014 | DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Intermediary Tubing is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy . | Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination | Class II | Terminated | |
| Z-1278-2013 | DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine. | Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration. | Class II | Terminated | |
| Z-1176-2013 | ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles, Product Code: 223116. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures. | The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain