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Panels › Orthopedic › Product code HTO · Class 1

Reamer

Regulation 888.4540

0510(k)s in 12 months (14 all time)
0recalls in 12 months (83 all time)
20recalls that name a 510(k)
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Top companies in HTO

DateFirm and productCodeLinked 510(k)
Mar 1, 2024Synthes (USA) Products LLC
RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullar
Open, Classified
HTOK013527
K042899 +1
Feb 6, 2023Zimmer, Inc.
Identity Shoulder System Resection Planer 35mm Resection Planer
Open, Classified
HTONone listed
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.032S
Terminated
HTOK013527
K042899 +2
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.031S
Terminated
HTOK013527
K042899 +2
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.030S
Terminated
HTOK013527
K042899 +2
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S
Terminated
HTOK013527
K042899 +2
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S
Terminated
HTOK013527
K042899 +2
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.027S
Terminated
HTOK013527
K042899 +2
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.026S
Terminated
HTOK013527
K042899 +2
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S
Terminated
HTOK013527
K042899 +2
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.024S
Terminated
HTOK013527
K042899 +2
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.023S
Terminated
HTOK013527
K042899 +2
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S
Terminated
HTOK013527
K042899 +2
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S
Terminated
HTOK013527
K042899 +2
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S
Terminated
HTOK013527
K042899 +2
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S
Terminated
HTOK013527
K042899 +2
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S
Terminated
HTOK013527
K042899 +2
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.017S
Terminated
HTOK013527
K042899 +2
Nov 19, 2020Synthes (USA) Products LLC
DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S
Terminated
HTOK013527
K042899 +2
Jan 20, 2020T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
FlipCutter III Drill
Terminated
HTONone listed
Sep 13, 2018Arthrex, Inc.
3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant.
Open, Classified
HTONone listed
Aug 4, 2017Encore Medical, Lp
MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58
Terminated
HTONone listed
Jul 26, 2017Synthes (USA) Products LLC
Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Terminated
HTONone listed
Jul 26, 2017Synthes (USA) Products LLC
2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Terminated
HTONone listed
Jul 26, 2017Synthes (USA) Products LLC
2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Terminated
HTONone listed
Jul 26, 2017Synthes (USA) Products LLC
3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Terminated
HTONone listed
Jul 26, 2017Synthes (USA) Products LLC
2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Terminated
HTONone listed
Jul 26, 2017Synthes (USA) Products LLC
2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Terminated
HTONone listed
Jul 26, 2017Synthes (USA) Products LLC
2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Terminated
HTONone listed
Nov 23, 2016Synthes (USA) Products LLC
Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.
Terminated
HTONone listed
Nov 19, 2016Synthes (USA) Products LLC
2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
Terminated
HTONone listed
Nov 19, 2016Synthes (USA) Products LLC
2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
Terminated
HTONone listed
Nov 19, 2016Synthes (USA) Products LLC
2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
Terminated
HTONone listed
Nov 19, 2016Synthes (USA) Products LLC
3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
Terminated
HTONone listed
Nov 19, 2016Synthes (USA) Products LLC
3.0 mm Reaming Rod/950 mm, Sterile
Terminated
HTONone listed
Nov 19, 2016Synthes (USA) Products LLC
2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile
Terminated
HTONone listed
Jun 6, 2016Synthes (USA) Products LLC
DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
Terminated
HTONone listed
May 26, 2016Biomet, Inc.
Various trauma and sports medicine instruments and implants. Reamer.
Terminated
HTONone listed
Jan 5, 2016Synthes (USA) Products LLC
SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
Terminated
HTONone listed
Aug 24, 2015Trilliant Surgical Ltd.
Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Reamer Head, 18 mm; Convex Reamer Head 20 mm; Convex Re
Terminated
HTOK121452
Aug 10, 2015Synthes (USA) Products LLC
8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use wi
Terminated
HTONone listed
Jul 16, 2015Synthes, Inc.
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to
Terminated
HTOK111437
Oct 6, 2014Biomet, Inc.
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthrop
Terminated
HTONone listed
Aug 12, 2013Synthes USA HQ, Inc.
Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.
Terminated
HTONone listed
Mar 20, 2013DePuy Orthopaedics, Inc.
ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip Prosthesis System. The ReClaim Reamer Extension is as an attachment to the distal reamers to allow the surgeo
Terminated
HTONone listed
Dec 17, 2012DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstructi
Terminated
HTONone listed
Dec 4, 2012Biomet, Inc.
OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial pr
Terminated
HTONone listed
Dec 4, 2012Biomet, Inc.
OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial prepar
Terminated
HTONone listed
Nov 26, 2012Extremity Medical LLC
IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone
Terminated
HTONone listed
May 17, 2012Stryker Howmedica Osteonics Corp.
Cutting Edge Acetabular Spherical Reamer 44 M, Stryker Howmedica Osteonics Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA. The CuttingEdge acetabular reamers are used to ream the
Terminated
HTONone listed

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