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 4, 2011 | Biomet, Inc. Cylindrical Reamer Bullet Nose Straight Flutes 20.5 mm x 250 mm, REF 475829, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Mar 4, 2011 | Biomet, Inc. Cylindrical Bullet Nose Reamer 19.5 mm x 250 mm, REF 475827, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Mar 4, 2011 | Biomet, Inc. Cylindrical Bullet Nose Reamer 19.0 mm x 250 mm, REF 475826, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Mar 4, 2011 | Biomet, Inc. Cylindrical Bullet Nose Reamer 18.0 mm x 250 mm, REF 475824, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Mar 4, 2011 | Biomet, Inc. Cylindrical Bullet Nose Reamer 17.5 mm x 250 mm, REF 475823, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Mar 4, 2011 | Biomet, Inc. Cylindrical Bullet Nose Reamer 15.5 mm x 250 mm, REF 475819, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Mar 4, 2011 | Biomet, Inc. Cylindrical Bullet Nose Reamer 15.0 mm x 250 mm, REF 475818, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Mar 4, 2011 | Biomet, Inc. Cylindrical Bullet Nose Reamer 14.5 mm x 250 mm, REF 475817, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Mar 4, 2011 | Biomet, Inc. Cylindrical Bullet Nose Reamer 14.0 mm x 250 mm, REF 475816, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Mar 4, 2011 | Biomet, Inc. Cylindrical Bullet Nose Reamer 13.5 mm x 250 mm, REF 475815, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Mar 4, 2011 | Biomet, Inc. Cylindrical Bullet Nose Reamer 13.0 mm x 250 mm, REF 475814, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Mar 4, 2011 | Biomet, Inc. Cylindrical Bullet Nose Reamer 12.5 mm x 250 mm, REF 475813, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Mar 4, 2011 | Biomet, Inc. Cylindrical Bullet Nose Reamer 12.0 mm x 250 mm, REF 475812, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Mar 4, 2011 | Biomet, Inc. Cylindrical Bullet Nose Reamer 11.5 mm x 250 mm, REF 475811, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Mar 4, 2011 | Biomet, Inc. Cylindrical Bullet Nose Reamer 11.0 mm x 250 mm, REF 475810, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Mar 4, 2011 | Biomet, Inc. Cylindrical Bullet Nose Reamer 10.5 mm x 250 mm, REF 475809, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Mar 4, 2011 | Biomet, Inc. Cylindrical Bullet Nose Reamer 9.5 mm x 250 mm, REF 475807, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Mar 4, 2011 | Biomet, Inc. Cylindrical Bullet Nose Reamer 8.5 mm x 250 mm, REF 475805, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Mar 4, 2011 | Biomet, Inc. Cylindrical Bullet Nose Reamer 8.0 mm x 250 mm, REF 475804, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Mar 4, 2011 | Biomet, Inc. Cylindrical Bullet Nose Reamer 7.5 mm x 250 mm, REF 475803, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Mar 4, 2011 | Biomet, Inc. Cylindrical Bullet Nose Reamer 7.0 mm x 250 mm, REF 475802, Biomet Orthopedics 66 East Bell Drive Warsaw IN.
The product is used to prepare the femoral canal for stem implantation. Terminated |
HTO | None listed |
| Apr 28, 2010 | Cayenne Medical Inc. AperFix Femoral Implant Coring Removal Drill, labeled as the following:
a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109;
b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110;
Terminated |
HTO | None listed |
| Feb 17, 2010 | Stryker Howmedica Osteonics Corp. Navigation Reamer T-handle; Non Sterile; Howmedica Osteonics, 325 Corporate Drive, Mahwah, NJ 07430.
Intended for use in orthopaedic surgery to interface with various cutting instruments and drivers. Terminated |
HTO | None listed |
| Feb 17, 2010 | Stryker Howmedica Osteonics Corp. Reamer T-Handle; Non- Sterile; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430.
Intended for use in orthopaedic surgery to interface with various cutting instruments and drivers. Terminated |
HTO | None listed |
| Jan 13, 2009 | Sterilmed Inc Reamers
Model #'s:
HAL5091-144 and
ZIMS5979-95-41
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other d Terminated |
HTO | None listed |
| Aug 27, 2008 | Stryker Howmedica Osteonics Corp. Xcelerate Patella System Reamer Shaft Assembly;
Non-Sterile;
Howmedica Osteonics Corp.,
325 Corporate Drive;
Mahwah, NJ 07430
Authorized representative in Europe:
Stryker France ZAC Satolas Green Pusi Terminated |
HTO | None listed |
| Oct 19, 2006 | Medtronic Sofamor Danek Instrument Manufacturing Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Manufactured at: Bartlett Tennessee USA, Rx only. The product is a bone reamer which is sterilized at the point of use (hospital/c Terminated |
HTO | None listed |
| Jul 20, 2004 | Apex Surgical, LLC Apex Pilot Shaft 17.5mm Terminated |
HTO | None listed |
| Jul 20, 2004 | Apex Surgical, LLC Apex Pilot Shaft 16mm Terminated |
HTO | None listed |
| Jul 20, 2004 | Apex Surgical, LLC Apex Pilot Shaft 14.4mm Terminated |
HTO | None listed |
| Jul 20, 2004 | Apex Surgical, LLC Apex Pilot Shaft 13mm Terminated |
HTO | None listed |
| Jul 20, 2004 | Apex Surgical, LLC Apex Pilot Shaft, 11.5mm Terminated |
HTO | None listed |
| Jul 20, 2004 | Apex Surgical, LLC Apex Pilot Shaft, 10mm Terminated |
HTO | None listed |
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