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) |
|---|---|---|---|
| Dec 1, 2011 | Acute Innovations Llc 10mm x 2.7mm RibLoc Screw, a component of the RibLoc Rib Fracture Plating System, Model RBP1202.
The product is labeled in parts: "***Ribloc Rib Fracture Plating System***MATERIAL: Titanium***Rx ONLY Terminated |
HRS | K051410 |
| Aug 29, 2011 | Orthohelix Surgical Designs Inc Mini MaxLock Extreme Plating System Case & Tray, Model Number(s): MXM-901,
Product Usage: The Mini MaxLock Extreme Plating System is intended to stabilize and aid in the repair of fractures, fusion Terminated |
HRS | K101962 |
| Mar 7, 2011 | Depuy Orthopaedics, Inc. PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 9 hole, Sterile, REF 8141-30-109, Depuy Orthopaedics, Inc., Warsaw, IN. Terminated |
HRS | K060969 |
| Mar 7, 2011 | Depuy Orthopaedics, Inc. PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 18 hole, Sterile, REF 8141-31-118, Depuy Orthopaedics, Inc., Warsaw, IN. Terminated |
HRS | K060969 |
| Mar 7, 2011 | Depuy Orthopaedics, Inc. POLYAX FEMORAL PLATE - LEFT, 15 hole, Sterile, REF 8141-31-115, Depuy Orthopaedics, Inc., Warsaw, IN. Terminated |
HRS | K060969 |
| Mar 7, 2011 | Depuy Orthopaedics, Inc. PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 12 hole, Sterile, REF 8141-31-112, Depuy Orthopaedics, Inc., Warsaw, IN. Terminated |
HRS | K060969 |
| Mar 7, 2011 | Depuy Orthopaedics, Inc. PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 9 hole, Sterile, REF 8141-31-109, Depuy Orthopaedics, Inc., Warsaw, IN. Terminated |
HRS | K060969 |
| Mar 7, 2011 | Depuy Orthopaedics, Inc. PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 6 hole, Sterile, REF 8141-31-106, Depuy Orthopaedics, Inc., Warsaw, IN. Terminated |
HRS | K060969 |
| Mar 7, 2011 | Depuy Orthopaedics, Inc. PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 18 hole, Sterile, REF 8141-30-118, Depuy Orthopaedics, Inc., Warsaw, IN. Terminated |
HRS | K060969 |
| Mar 7, 2011 | Depuy Orthopaedics, Inc. PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 15 hole, Sterile, REF 8141-30-115, Depuy Orthopaedics, Inc., Warsaw, IN. Terminated |
HRS | K060969 |
| Mar 7, 2011 | Depuy Orthopaedics, Inc. PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 12 hole, Sterile, REF 8141-30-112, Depuy Orthopaedics, Inc., Warsaw, IN. Terminated |
HRS | K060969 |
| Mar 7, 2011 | Depuy Orthopaedics, Inc. PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 6 hole, Sterile, REF 8141-30-106, Depuy Orthopaedics, Inc.Warsaw, IN. Terminated |
HRS | K060969 |
| Feb 16, 2011 | Stryker Howmedica Osteonics Corp. S T-Bone Plate;
M T-Compression Plate;
Manufactured and Distributed by Stryker Lebinger GmbH & Co.
Freiburg, Germany.
The Profyle System is intended for use in internal fixation of the bones of hand a Terminated |
HRS | K062498 |
| Jan 25, 2011 | Integra LifeSciences Corp. Newdeal (Newdeal Compression Plate) Model #UNI-CP 339900 Sets, Lot Numbers: E71H, E7V1, E86R, EELE, EGTC
The Newdeal Compression Plates are intended for fixation of bone fractures or for bone reconst Terminated |
HRS | K070447 K091609 |
| Nov 2, 2010 | Synthes USA (HQ), Inc. 3.5mm LCP Periarticular Proximal Humerus Plates
Indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly for patients with osteopenic bone Terminated |
HRS | K082625 |
| Aug 31, 2010 | Smith & Nephew Inc PERI-LOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATE, 10 HOLE, RIGHT - 148 MM, REF 71800710, QTY: (1), STERILE R, CE 0086, Smith & Nephew, Inc., Memphis, TN 38116, USA, EC REP: Smith & Nephew Orth Terminated |
HRS | K033669 |
| Aug 9, 2010 | Wright Medical Technology Inc CLAW HEX SCREW CHARLOTTE " F&A SYSTEM CONTENTS: 1 EACH Foot and Ankle Screw ... IMPLANT MATERIAL: Stainless Steel Ref: 4013-3520 ... Size 3.5MM, Length 20 MM, Use with Clava 3.5MM - Non-Steril Terminated |
HRS | K080295 |
| Jun 16, 2010 | Acumed LLC Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar Shortening Saw Blade - Hub Style S, REF 80-0499-S, Material: Stainless Steel, STERILE, Rx Only, ACUMED, Hillsboro, OR, U Terminated |
HRS | K012655 |
| Feb 24, 2010 | Synthes USA (HQ), Inc. Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S. Terminated |
HRS | K021458 |
| Jun 1, 2009 | Synthes Spine Synthes InSitu Bender Cutter Kit Narrow Sterile Catalog number 530.522S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures. Terminated |
HRS | K021458 |
| Jun 1, 2009 | Synthes Spine Synthes InSitu Bender Cutter Kit Wide Sterile Catalog number 530.521S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures. Terminated |
HRS | K021458 |
| May 27, 2009 | Biomet Microfixation, Inc. Lactosorb Pectus Stabilizer, model number: 01-3805. Distributed and Manufactured by : Biomet Microfixation, Jacksonville, FL.
LactoSorb Pectus Stabilizer is a surgical implant intended to aid in the Terminated |
HRS | K071577 |
| May 21, 2009 | Synthes Spine In Situ Bender Cutter Kit Narrow Sterile, Catalog number 530.522S.
Used with Synthes' Rapid Resorbable Fixation System which is intended for use in fracture repair and reconstructive procedures of th Terminated |
HRS | K021458 |
| May 21, 2009 | Synthes Spine In Situ Bender Cutter Kit Wide Sterile, Catalog number 530.521S
Used with Synthes' Rapid Resorbable Fixation System which is intended for use in fracture repair and reconstructive procedures of the c Terminated |
HRS | K021458 |
| Apr 13, 2009 | Stryker Howmedica Osteonics Corp. AxSOS Torque Limiting Screwdriver, T8 1.5 Nm 3.0mm Locking Set. REF 702749. This product is non sterile.
Distributed in the USA by Howmedica Osteonics Corp, Mahwah, NJ.
The torque limiter is used fo Terminated |
HRS | K061012 |
| Apr 13, 2009 | Stryker Howmedica Osteonics Corp. AxSOS T8 Screwdriver, 3.0mm Locking Set. REF 702746. This product is non sterile. Distributed in the USA by Howmedica Osteonics Corp, Mahwah, NJ.
The screwdrivers of the AxSOS system are multiple u Terminated |
HRS | K061012 |
| Feb 11, 2009 | Depuy Orthopaedics, Inc. DePuy DNP Anatomic Fracture Repair System, DNP Anatomic Right, Depuy, Warsaw, IN; REF DNPAR.
The device is used in the treatment of fractures and osteotomies of the distal radius. Terminated |
HRS | K052248 |
| Feb 11, 2009 | Depuy Orthopaedics, Inc. DePuy DNP Anatomic Fracture Repair System, DNP Anatomic Left, Depuy, Warsaw, IN; REF DNPAL.
The device is used in the treatment of fractures and osteotomies of the distal radius. Terminated |
HRS | K052248 |
| Feb 11, 2009 | Depuy Orthopaedics, Inc. DePuy DNP Anatomic Fracture Repair System, JIG DNP Anatomic, Depuy, Warsaw, IN; REF DNPAJIG.
The device is used in the treatment of fractures and osteotomies of the distal radius. Terminated |
HRS | K052248 |
| Feb 11, 2009 | Depuy Orthopaedics, Inc. DePuy DNP Anatomic Fracture Repair System, Locking Screw DNP Anatomic, Depuy, Warsaw, IN; REF DNPALS.
The device is used in the treatment of fractures and osteotomies of the distal radius. Terminated |
HRS | K052248 |
| Dec 1, 2008 | Integra LifeSciences Corp Uni-CP Compression Forceps (spreader);
Non-sterile, R only, Catalog number: 339001ND
Newdeal, Lyon, France;
Integra, 411 Enterprise Drive, Plainsboro, NJ 08536
Intended to open the UNI-Compression P Terminated |
HRS | K070447 |
| Sep 11, 2008 | Zimmer Inc. Zimmer 4.5 Compression plate-broad, 10 hole, 167 MM length, stainless steel, non sterile, Manufactured at Zimmer; REF 4945-10-01. The product is used for stabilization of fractures during the normal Terminated |
HRS | None listed |
| Aug 28, 2008 | Acumed LLC Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Radius Plate, Standard, Left... PL-DR50L W48003... Manufactured or Distributed by: Acumed LLC Hillsboro, OR ". Terminated |
HRS | K012655 |
| Mar 25, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Locking Screw, T7, Catalog Number: 40-27622, Size: 2.7X22MM, Non Sterile,Titanium Alloy; Manufactured and Distributed by: Stryker Leibinger GmbH & Co. KG;Boetzinger Strasse 41; Terminated |
HRS | None listed |
| Dec 19, 2007 | OrthoHelix Surgical Designs Inc DRL System Trays comprised of DRLock Bone Fixation Plates, Pegs, and Screw Systems: Four Plate Styles include: Part Numbers: DRV-002-0L Fixed Short Left Plate, DRV-002-0R , Fixed Short Right Plate, D Terminated |
HRS | K053182 |
| Jan 19, 2007 | OrthoHelix Surgical Designs Inc DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an aluminum tray case that contains the following: IMPLANTS:
6 stainless steel plates (2-lefts, 2-rights, and 1-righ Terminated |
HRS | K053182 |
| Jan 11, 2007 | Synthes LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465 Terminated |
HRS | K012114 |
| Mar 9, 2006 | Orthohelix Surgical Designs Inc MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with the MaxLock Plate and Screw System. Terminated |
HRS | None listed |
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