Panels › Orthopedic › Product code HTY · Class 2
Pin, Fixation, Smooth
Regulation 888.3040
3510(k)s in 12 months (206 all time)
1recalls in 12 months (32 all time)
27recalls that name a 510(k)
Top companies in HTY
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Biomet, Inc. | 0 | 14 |
| Arthrex, Inc. | 13 | 0 |
| Biomet, Inc. | 5 | 2 |
| OSSIO , Ltd. | 6 | 0 |
| Synthes (Usa) | 5 | 0 |
| Bioretec, Ltd. | 4 | 0 |
| The Huxley Instrument Corp. | 4 | 0 |
| OrthoPediatrics Corp. | 4 | 0 |
| Paragon 28 | 3 | 1 |
| Smith & Nephew, Inc. | 1 | 3 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 6, 2006 | K061164 | ACTIVAPIN Bioretec, Ltd., FI | HTY |
| Apr 28, 2006 | K060654 | DSI PINS AND WIRES Delta Surgical Instruments, Inc. | HTY |
| Feb 22, 2006 | K060283 | TRANSET SYSTEM Bonutti Research, Inc. | HTY |
| Nov 3, 2005 | K052736 | ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT Arthrex, Inc. | HTY |
| Aug 10, 2005 | K051605 | SBI K-WIRES Small Bone Innovations, LLC | HTY |
| May 27, 2005 | K050259 | ARTHREX BIO-PIN Arthrex, Inc. | HTY |
| Apr 18, 2005 | K043339 | REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG Xtremi-T, LLC | HTY |
| Mar 7, 2005 | K050275 | MODIFICATION TO: INION OTPS BIODEGRADABLE PIN Inion , Ltd., FI | HTY |
| Jan 19, 2005 | K043106 | PINN-ACL CROSSPIN Linvatec Corp. | HTY |
| Jul 30, 2004 | K041355 | HUMERAL STAPLE Smith & Nephew, Inc. | HTY |
| Jul 30, 2004 | K041157 | MODIFICATION TO SMALL BONE FIXATION SYSTEM Hand Innovations, Inc. | HTY |
| Jun 10, 2004 | K041288 | MODIFICATION TO SMARTPIN Linvatec Biomaterials, Inc., FI | HTY |
| May 25, 2004 | K040500 | ARTHROTEK LACTONAIL Arthrotek, Inc. | HTY |
| Feb 25, 2004 | K033717 | TRANSET FRACTURE FIXATION SYSTEM Bonutti Research, Inc. | HTY |
| Feb 20, 2004 | K033968 | HANSSON PIN SYSTEM Howmedica Osteonics Corp. | HTY |
| Jan 15, 2004 | K033406 | SMALL BONE FIXATION SYSTEM Hand Innovations, Inc. | HTY |
| Jan 15, 2004 | K024185 | BIODHOC Future Medical Systems, SA | HTY |
| Oct 6, 2003 | K032687 | ACE NANCY NAIL DePuy Orthopaedics, Inc. | HTY |
| Aug 28, 2003 | K031712 | INION OTPS BIODEGRADABLE PIN Inion , Ltd., FI | HTY |
| Jun 12, 2003 | K031083 | OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500 Opus Medical, Inc. | HTY |
| Mar 25, 2003 | K030665 | BONE WIRE Stork Instrumente GmbH | HTY |
| Nov 1, 2002 | K022597 | K-FIX New Deal, S.A. | HTY |
| Oct 30, 2002 | K022599 | NEWDEAL K WIRE New Deal, S.A. | HTY |
| Aug 26, 2002 | K022531 | 2MM PEDIATRIC FLEX NAIL Biomet, Inc. | HTY |
| May 1, 2002 | K013888 | FIXATION (STEINMANN) PINS Miltex, Inc. | HTY |
| Mar 29, 2002 | K014305 | RESORBABLE LACTOSORB-L ACL CROSSPIN Arthrotek, Inc. | HTY |
| Feb 6, 2002 | K013781 | RIDIDFIX 2.7MM BTB CROSS PIN KIT Mitek Products | HTY |
| Dec 20, 2001 | K013424 | INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND Hand Innovations, Inc. | HTY |
| Sep 17, 2001 | K012125 | OPUS MAGNUM ANCHOR & INSERTER Opus Medical, Inc. | HTY |
| Aug 24, 2001 | K012161 | FLEX-NAILS Fixano SA | HTY |
| Jul 31, 2001 | K011522 | RESORBABLE BONE PINS Biomet, Inc. | HTY |
| Jun 13, 2001 | K010983 | PLLA PIN Bionx Implants, Inc., FI | HTY |
| May 8, 2001 | K010479 | MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR Bonutti Research, Inc. | HTY |
| Apr 9, 2001 | K003527 | MODIFICATION TO SYNTHES (USA) POLYPIN Synthes (Usa) | HTY |
| Feb 20, 2001 | K003659 | PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 Bionx Implants, Inc., FI | HTY |
| Oct 11, 2000 | K002125 | PINS AND WIRES Implant Resource, Inc. | HTY |
| Aug 4, 2000 | K991971 | ARTHREX CHONDRAL DART, MODEL AR-4005B-18 Arthrex, Inc. | HTY |
| Mar 1, 2000 | K994232 | PHALANGEAL FIXATION SYSTEM Medcanica, Inc. | HTY |
| Jun 23, 1999 | K991064 | METACARPAL FIXATION SYSTEM Medcanica, Inc. | HTY |
| Mar 23, 1999 | K990291 | LACTOSORB BONE PIN Biomet, Inc. | HTY |
| Oct 5, 1998 | K983121 | NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220 Syntec Scientific Corp., TW | HTY |
| Sep 25, 1998 | K982719 | THE BONE TIE Surgicraft , Ltd., GB | HTY |
| Aug 11, 1998 | K980854 | RETROGRADE PEDIATRIC NAIL Encore Orthopedics, Inc. | HTY |
| Apr 16, 1998 | K974341 | MITEK BTB ABSORBABLE (PLA) CROSS PIN Mitek Products | HTY |
| Mar 5, 1998 | K974291 | MITEK BTB ABSORBABLE (PLA) CROSS PIN Mitek Products | HTY |
| Nov 20, 1997 | K973240 | SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION Synthes (Usa) | HTY |
| Aug 11, 1997 | K971962 | OSTEO KIRSCHNER WIRES Osteonics Corp. | HTY |
| Jul 18, 1997 | K971783 | SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM Synthes (Usa) | HTY |
| Jun 24, 1997 | K971453 | ORTHOTEC K-CAP SYSTEM Orthotech | HTY |
| May 9, 1997 | K961608 | SYNTHES (U.S.A.) POLYPIN Synthes (Usa) | HTY |
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