Panels › Orthopedic › Product code HRS · Class 2
Plate, Fixation, Bone
Regulation 888.3030
64510(k)s in 12 months (1,334 all time)
20recalls in 12 months (288 all time)
277recalls that name a 510(k)
Top companies in HRS
| Company | 510(k)s | Recalls |
|---|---|---|
| Synthes | 104 | 8 |
| Smith & Nephew | 37 | 16 |
| Biomet | 21 | 28 |
| Wrightmedicaltechnologyinc | 45 | 0 |
| Zimmer GmbH | 32 | 12 |
| Arthrex, Inc. | 40 | 3 |
| Wright Medical Technology Inc | 0 | 43 |
| DePuy Orthopaedics, Inc. | 18 | 14 |
| Medartis AG | 32 | 0 |
| TriMed, Inc. | 25 | 6 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R.
Orthopedic use. Terminated |
HRS | K132594 |
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L.
Orthopedic use. Terminated |
HRS | K132594 |
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, LAPIDUS CX plate, 2mm Step, Right, REF CCP-LPX2R.
Orthopedic use. Terminated |
HRS | K132594 |
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L.
Orthopedic use. Terminated |
HRS | K132594 |
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Right, REF CCP-LPX1R.
Orthopedic use. Terminated |
HRS | K132594 |
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L.
Orthopedic use. Terminated |
HRS | K132594 |
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right, REF CCP-LPX0R.
Orthopedic use. Terminated |
HRS | K132594 |
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Left, REF CCP-LPX0L.
Orthopedic use. Terminated |
HRS | K132594 |
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Right, REF CCP-HSX1R.
Orthopedic use. Terminated |
HRS | K132594 |
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Left, REF CCP-HSX1L.
Orthopedic use. Terminated |
HRS | K132594 |
| Sep 8, 2014 | Wright Medical Technology, Inc. CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EACH, Rx ONLY, NON STERILE
Orthopedic Terminated |
HRS | K080295 K113014 +1 |
| Sep 8, 2014 | Wright Medical Technology, Inc. CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EACH, Rx ONLY, NON STERILE
Orthopedic Terminated |
HRS | K080295 K113014 +1 |
| Sep 8, 2014 | Wright Medical Technology, Inc. CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF 40242020, 1 EACH, Rx ONLY, NON STERILE
Orthopedic Terminated |
HRS | K080295 K113014 +1 |
| Sep 8, 2014 | Wright Medical Technology, Inc. CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON STERILE
Orthopedic Terminated |
HRS | K080295 K113014 +1 |
| Sep 8, 2014 | Wright Medical Technology, Inc. CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONLY, NON STERILE
Orthopedic Terminated |
HRS | K080295 K113014 +1 |
| Sep 8, 2014 | Wright Medical Technology, Inc. CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE
Orthopedic Terminated |
HRS | K080295 K113014 +1 |
| Sep 8, 2014 | Wright Medical Technology, Inc. CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE
Orthopedic Terminated |
HRS | K080295 K113014 +1 |
| Sep 8, 2014 | Wright Medical Technology, Inc. CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF 4013-0130, 1 EACH, Rx ONLY, NON STERILE
Orthopedic Terminated |
HRS | K080295 K113014 +1 |
| Sep 8, 2014 | Wright Medical Technology, Inc. CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON STERILE
Orthopedic Terminated |
HRS | K080295 K113014 +1 |
| Aug 26, 2014 | Zimmer, Inc. Trauma Tubes and Plates:
TUBE & SCP PLT 90DX150LG
TUBE & SCP PLT 90DX205LG
TUBE & SCP PLT 90DX255LG
TUBE & SCP PLT 95DX150LG
TUBE & SCP PLT 95DX205LG
TUBE & SCP PLT 95DX255LG
TUBE&SCP PLT 130DX8H
TUBE Terminated |
HRS | K830196 |
| Aug 13, 2014 | Biomet, Inc. Device Brand Name: Distal Radius Fracture Repair System
Device Classification Name: Plate, Fixation, Bone
Device Common Name: Drill Guide DNP 3.3mm
Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0 Terminated |
HRS | K041081 K052248 |
| Jul 30, 2014 | Zimmer, Inc. Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilizati Terminated |
HRS | K040593 |
| Apr 25, 2014 | Acumed LLC The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire.
50.0 Terminated |
HRS | K931244 |
| Mar 25, 2014 | Synthes, Inc. Drill Template and the Saw Guide for the Ulna Osteotomy System.
Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, includi Terminated |
HRS | K113364 |
| Mar 11, 2014 | Synthes, Inc. Synthes Small Notch Titanium Reconstructive Plate
Product Usage:
The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercial Terminated |
HRS | K915818 |
| Feb 20, 2014 | Zimmer, Inc. 3.5 COMP PLT, 4 HOLE
3.5 COMP PLT, 5 HOLE
3.5 COMP PLT, 6 HOLE
3.5 COMP PLT, 8 HOLE
3.5 COMP PLT, 9 HOLE
3.5 COMP PLT, 10 HOLE Terminated |
HRS | None listed |
| Jan 28, 2014 | ACUTE Innovations, LLC The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fractures, fusions and osteotomies during the normal bone healing pro Terminated |
HRS | K113318 |
| Jan 10, 2014 | Biomet, Inc. Locking Cortical Screw
3.5mmX38mm
REF 8161-35-038 Terminated |
HRS | K072083 K072832 +1 |
| Dec 27, 2013 | Zimmer, Inc. FEM COND BUTTRESS PLT, LT Terminated |
HRS | K082078 |
| Dec 27, 2013 | Zimmer, Inc. DIST LAT FEM LOCK PLT, RT Terminated |
HRS | K082078 |
| Dec 27, 2013 | Zimmer, Inc. FEM COND BUTTRESS PLT, RT. Terminated |
HRS | K082078 |
| Nov 27, 2013 | Synthes (USA) Products LLC Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm
Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand. Terminated |
HRS | K001941 |
| Nov 22, 2013 | Synthes USA HQ, Inc. 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM
Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in Terminated |
HRS | K063049 |
| Nov 14, 2013 | OrthoPediatrics Corp 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM
The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages o Terminated |
HRS | None listed |
| Aug 27, 2013 | Zimmer, Inc. ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM
DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT
RIGHT 11 HOLES 178 MM LENGTH
STERILE RX ONLY
Product Usage: Usage:
The Periarticular Locking Plate System Terminated |
HRS | K082078 |
| Aug 26, 2013 | Synthes USA HQ, Inc. Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right
Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other s Terminated |
HRS | K083694 |
| Aug 26, 2013 | Synthes (USA) Products LLC Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm
Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular frac Terminated |
HRS | K071184 K083694 +1 |
| Jun 19, 2013 | Synthes USA HQ, Inc. Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011 Terminated |
HRS | K011335 |
| Jun 5, 2013 | Toby Orthopaedics, Inc. PANTERA Proximal Humerus Fracture Plate System Terminated |
HRS | K081608 |
| Mar 15, 2013 | Synthes USA HQ, Inc. Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431.
Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Corrective osteotomies Terminated |
HRS | K102694 |
| Nov 22, 2012 | OrthoPediatrics Corp 4.5mm PLEO Osteotomy Guide.
OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Terminated |
HRS | K083286 |
| Nov 6, 2012 | Zimmer, Inc. NCB-PH Plate Terminated |
HRS | K081759 |
| Nov 6, 2012 | Zimmer, Inc. NCB-PT lateral proximal 3 hole tibial plate Terminated |
HRS | K061211 |
| Aug 10, 2012 | Zimmer, Inc. The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile
Product is implantable screws indicated for temporary internal fixation and stabilization of fractures and osteotomie Terminated |
HRS | K042695 |
| Aug 1, 2012 | Integra LifeSciences Corp. Integra Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536
The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneifor Terminated |
HRS | K070241 |
| Jul 20, 2012 | OrthoPediatrics Corp OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right.
Used for pediatric patients as indicated for pelvic, small and long bone fractures. Terminated |
HRS | K083286 |
| Apr 19, 2012 | Biomet, Inc. Optilock, Locking Screw 3.5 mm x 28 mm, non sterile, REF 37728, Biomet Trauma Parsippany, NJ 97054.
Cortical Locking Screw for securing a Proximal Humeral Plate to the bone in the Optilock system. Terminated |
HRS | K062494 |
| Mar 2, 2012 | Integra LifeSciences Corp. Titanium SURFIX ALPHA SCREWS, a component of the Newdeal Hallu Lock Plate System. Surfix Alpha Variable angle locking system exists in different diameters and lengths. The product can be sold as a re Terminated |
HRS | K083154 |
| Jan 24, 2012 | Biomet Microfixation, Inc. The SternaLock Blu Implant Tray includes plates, screws, screw measuring device, and blades.
The SternaLock Blu Implant Tray would have been found within the following outer containers:
Silver Instr Terminated |
HRS | K110574 |
| Jan 11, 2012 | Orthohelix Surgical Designs Inc MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY.
Product Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and Terminated |
HRS | K102156 |
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