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)
Top companies in HTO
| Company | 510(k)s | Recalls |
|---|---|---|
| Synthes (USA) Products, LLC | 1 | 35 |
| Biomet, Inc. | 0 | 25 |
| Apex Surgical, LLC | 0 | 6 |
| Stryker Howmedica Osteonics Corp. | 0 | 4 |
| Synthes (Usa) | 3 | 1 |
| Depuy, Inc. | 2 | 0 |
| Zimmer, Inc. | 1 | 1 |
| 3M Company | 1 | 0 |
| The Anspach Effort, Inc. | 1 | 0 |
| Arthrex, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2024 | Synthes (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 |
HTO | K013527 K042899 +1 |
| Feb 6, 2023 | Zimmer, Inc. Identity Shoulder System Resection Planer 35mm Resection Planer Open, Classified |
HTO | None listed |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.032S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.031S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.030S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.029S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument
Part Code: 03.404.028S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.027S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument
Part Code: 03.404.026S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.025S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.024S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2
STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.023S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.022S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument
Part Code: 03.404.021S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument
Part Code: 03.404.020S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.019S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.018S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.017S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.016S Terminated |
HTO | K013527 K042899 +2 |
| Jan 20, 2020 | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. FlipCutter III Drill Terminated |
HTO | None listed |
| Sep 13, 2018 | Arthrex, 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 |
HTO | None listed |
| Aug 4, 2017 | Encore 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 |
HTO | None listed |
| Jul 26, 2017 | Synthes (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 |
HTO | None listed |
| Jul 26, 2017 | Synthes (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 |
HTO | None listed |
| Jul 26, 2017 | Synthes (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 |
HTO | None listed |
| Jul 26, 2017 | Synthes (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 |
HTO | None listed |
| Jul 26, 2017 | Synthes (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 |
HTO | None listed |
| Jul 26, 2017 | Synthes (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 |
HTO | None listed |
| Jul 26, 2017 | Synthes (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 |
HTO | None listed |
| Nov 23, 2016 | Synthes (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 |
HTO | None listed |
| Nov 19, 2016 | Synthes (USA) Products LLC 2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile Terminated |
HTO | None listed |
| Nov 19, 2016 | Synthes (USA) Products LLC 2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile Terminated |
HTO | None listed |
| Nov 19, 2016 | Synthes (USA) Products LLC 2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile Terminated |
HTO | None listed |
| Nov 19, 2016 | Synthes (USA) Products LLC 3.0 mm Guide Rod/950 mm with Smooth Tip, sterile Terminated |
HTO | None listed |
| Nov 19, 2016 | Synthes (USA) Products LLC 3.0 mm Reaming Rod/950 mm, Sterile Terminated |
HTO | None listed |
| Nov 19, 2016 | Synthes (USA) Products LLC 2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile Terminated |
HTO | None listed |
| Jun 6, 2016 | Synthes (USA) Products LLC DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43 Terminated |
HTO | None listed |
| May 26, 2016 | Biomet, Inc. Various trauma and sports medicine instruments and implants.
Reamer. Terminated |
HTO | None listed |
| Jan 5, 2016 | Synthes (USA) Products LLC SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures. Terminated |
HTO | None listed |
| Aug 24, 2015 | Trilliant 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 |
HTO | K121452 |
| Aug 10, 2015 | Synthes (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 |
HTO | None listed |
| Jul 16, 2015 | Synthes, 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 |
HTO | K111437 |
| Oct 6, 2014 | Biomet, 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 |
HTO | None listed |
| Aug 12, 2013 | Synthes USA HQ, Inc. Synthes Flexible Medullary Reamer.
Intended to be used to facilitate the preparation of the intramedullary cavity. Terminated |
HTO | None listed |
| Mar 20, 2013 | DePuy 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 |
HTO | None listed |
| Dec 17, 2012 | DePuy 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 |
HTO | None listed |
| Dec 4, 2012 | Biomet, 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 |
HTO | None listed |
| Dec 4, 2012 | Biomet, 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 |
HTO | None listed |
| Nov 26, 2012 | Extremity 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 |
HTO | None listed |
| May 17, 2012 | Stryker 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 |
HTO | None listed |
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