Panels › Orthopedic › Product code HSB · Class 2
Rod, Fixation, Intramedullary And Accessories
Regulation 888.3020
20510(k)s in 12 months (532 all time)
19recalls in 12 months (690 all time)
680recalls that name a 510(k)
Top companies in HSB
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Biomet, Inc. | 0 | 295 |
| DePuy Orthopaedics, Inc. | 9 | 116 |
| Zimmer GmbH | 23 | 50 |
| Stryker | 12 | 37 |
| Howmedica Osteonics | 39 | 0 |
| OrthoPediatrics Corp. | 7 | 31 |
| Ebi, L.P. | 1 | 31 |
| Advanced Orthopaedic Solutions, Inc. | 15 | 12 |
| NuVasive Specialized Orthopedics | 18 | 9 |
| Synthes (Usa) | 23 | 4 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2016 | Zimmer Manufacturing B.V. M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542
M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 002253 Terminated |
HSB | K142281 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 60 consists of all product under product code: HSB and same usage:
Item no:
225207055 RECON SCREW LG 5.5MM DIA
225207555 RECON SCREW LG 5.5MM DIA
225208055 RECON SCREW LG 5.5MM DIA
225208555 Terminated |
HSB | K965098 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 55 consists of all product under product code: HSB and same usage:
Item no:
225900132 ONE-PIECE LAG SCREW 11MM
225900135 ONE-PIECE LAG SCREW 11MM
225900137 ONE-PIECE LAG SCREW 11MM
225900140 Terminated |
HSB | K032367 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 43 consists of all product under product code: HSB and same usage:
Item no:
224001016 M/DN R-F IM NAIL 10MM DIA
224001018 M/DN R-F IM NAIL 10MM DIA
224001020 M/DN R-F IM NAIL 10MM DIA
224001 Terminated |
HSB | K142281 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 42 consists of all product under product code: HSB and same usage:
Item no:
225224010 M/DN FEM IM NAIL 10MM DIA
225228010 M/DN FEM IM NAIL 10MM DIA
225230010 M/DN FEM IM NAIL 10MM DIA
225232 Terminated |
HSB | K965098 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 40 consists of all product under product code: HSB and same usage:
Item no:
225706565 ITST ANTI-ROTATION SCREW
225707065 ITST ANTI-ROTATION SCREW
225708065 ITST ANTI-ROTATION SCREW
225708565 Terminated |
HSB | K032367 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 38 consists of all product under product code: HSB and same usage:
Item no:
225303255 INTERLOCKING IM SCREW LG
225303555 INTERLOCKING IM SCREW LG
225303755 INTERLOCKING IM SCREW LG
225307055 Terminated |
HSB | K142281 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 37 consists of all product under product code: HSB and same usage:
Item no:
225302055 INTERLOCKING IM SCREW LG
225303055 INTERLOCKING IM SCREW LG
225304055 INTERLOCKING IM SCREW LG
225304555 Terminated |
HSB | K965098 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 36 consists of all product under product code: HSB and same usage:
Item no:
225302745 INTERLOCKING IM SCREW 4.5
225303045 INTERLOCKING IM SCREW 4.5
225303245 INTERLOCKING IM SCREW 4.5
225303 Terminated |
HSB | K143321 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 14 consists of all product under product code HSB
, and same usage:
Item no:
225600230 ASIA ONE-PIECE LAG SCREW
225600232 ASIA ONE-PIECE LAG SCREW
225600235 ASIA ONE-PIECE LAG SCREW
22560023 Terminated |
HSB | K032367 |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
HSB | K131365 |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
HSB | K123401 |
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
HSB | K063225 |
| Dec 4, 2015 | Synthes (USA) Products LLC Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intende Terminated |
HSB | K011857 |
| Oct 15, 2015 | Synthes (USA) Products LLC Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion. Terminated |
HSB | K131548 |
| Oct 14, 2015 | Zimmer Gmbh Zimmer Natural Nail CM Long. Intramedullary Fixation Rod.
The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Terminated |
HSB | K091566 |
| Jul 29, 2015 | Tornier, Inc Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument. Terminated |
HSB | K082754 |
| Jul 16, 2015 | Synthes (USA) Products LLC Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual Terminated |
HSB | K131548 |
| Jul 13, 2015 | Zimmer, Inc. ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device. Terminated |
HSB | K083497 |
| Jun 26, 2015 | Synthes, Inc. DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractur Terminated |
HSB | K040336 |
| Jun 8, 2015 | Vilex In Tennessee Inc Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25.
Ankle arthrodesis, tibio-talo-calcaneal arthrodesis. Terminated |
HSB | K102413 |
| Jun 8, 2015 | Vilex In Tennessee Inc Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25.
Ankle arthrodesis, tibio-talo-calcaneal arthrodesis. Terminated |
HSB | K102413 |
| Jun 8, 2015 | Vilex In Tennessee Inc Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25.
Ankle arthrodesis, tibio-talo-calcaneal arthrodesis. Terminated |
HSB | K102413 |
| May 12, 2015 | Synthes, Inc. TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma. Terminated |
HSB | K131548 |
| Apr 29, 2015 | Pega Medical Inc. Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures.
This instrument is included in the Fassier-Duval IM Teles Terminated |
HSB | K020885 K041393 |
| Apr 2, 2015 | Pega Medical Inc. GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28.
Product Usage:
The GAP Endo-Exo Medullary System is used for the t Terminated |
HSB | K111232 |
| Mar 30, 2015 | Synthes, Inc. Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing Sy Terminated |
HSB | K131548 |
| Nov 14, 2014 | Synthes, Inc. 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur Terminated |
HSB | K011857 |
| Nov 12, 2014 | Medacta Usa GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement.
Rod to obtain correct leg alignment during total knee replacement. Terminated |
HSB | None listed |
| Oct 14, 2014 | Stryker Howmedica Osteonics Corp. Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13.
Product Usage:
The T2 Tibial Nailing system is intended to provide temp Terminated |
HSB | K131365 |
| Apr 18, 2014 | Pega Medical Inc. Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS.
-Duval IM Telescopic System. Terminated |
HSB | K020885 K041393 |
| Apr 10, 2014 | Pega Medical Inc. Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod. Terminated |
HSB | K020885 K041393 |
| Feb 20, 2014 | Zimmer, Inc. ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900. Terminated |
HSB | K032367 |
| Feb 20, 2014 | Zimmer, Inc. ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM and 15 MM) DIA X (18, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48 and 50) Terminated |
HSB | K032367 |
| Feb 20, 2014 | Zimmer, Inc. ASIA ONE-PIECE LAG SCREW Terminated |
HSB | K032367 |
| Feb 20, 2014 | Zimmer, Inc. M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543. Terminated |
HSB | K965098 K965099 +3 |
| Feb 20, 2014 | Zimmer, Inc. INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM.
Some items starting with codes 0022530, 0022531, 002532, 0022533, 0022534 Terminated |
HSB | K965098 |
| Feb 20, 2014 | Zimmer, Inc. RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting with 0022520, 0022521, 002522, 0022523, 0022524 and 0022525. Terminated |
HSB | K962561 K965098 |
| Feb 20, 2014 | Zimmer, Inc. M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400 Terminated |
HSB | None listed |
| Jan 28, 2014 | Stryker Howmedica Osteonics Corp. Teflon Tube, sterile
T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5
24232 Sconkidrchen, Germany
distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA
510 Terminated |
HSB | K042396 |
| Dec 27, 2013 | Zimmer, Inc. TIB NAIL Terminated |
HSB | K130595 |
| Dec 27, 2013 | Zimmer, Inc. TIBIO FEM/FEM NAIL. Terminated |
HSB | K130595 |
| Dec 10, 2013 | Synthes USA HQ, Inc. Synthes Trochanteric Fixation Nail
As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur. Terminated |
HSB | K011857 |
| Dec 5, 2013 | Synthes USA HQ, Inc. Titanium Trochanteric Fixation Nail (TFN)System
Intended to treat stable and unstable fractures of the proximal femur. Terminated |
HSB | K011857 |
| Nov 25, 2013 | Synthes USA HQ, Inc. Large Buttress Compression Nut For Blade Guide Sleeve TFN
The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, in Terminated |
HSB | K011857 |
| Nov 20, 2013 | Synthes USA HQ, Inc. Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade
Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur in Terminated |
HSB | K070294 |
| Aug 26, 2013 | Synthes USA HQ, Inc. Synthes Trauma Nail System. The devices are indication for bone fixation. Terminated |
HSB | K011857 K033071 +3 |
| Jul 31, 2013 | Stryker Howmedica Osteonics Corp. GAMMA3 System Long Nail Kit, R2.0, Ti, Left
Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA
A single use device intended for the temporary fixation, correc Terminated |
HSB | None listed |
| Jul 16, 2013 | Integra LifeSciences Corporation Integra PANTA Arthrodesis Nail System.
Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Terminated |
HSB | K050882 K091788 |
| Apr 17, 2013 | Smith & Nephew Inc TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA
orthopedic surgery Terminated |
HSB | K111025 |
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