Panels › Orthopedic › Product code HWC · Class 2
Screw, Fixation, Bone
Regulation 888.3040
22510(k)s in 12 months (1,070 all time)
7recalls in 12 months (389 all time)
359recalls that name a 510(k)
Top companies in HWC
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer, Inc. | 12 | 50 |
| Biomet, Inc. | 24 | 27 |
| Arthrex, Inc. | 47 | 1 |
| Acumed, LLC | 5 | 35 |
| Depuy Mitek, A Johnson & Johnson Co. | 13 | 21 |
| Synthes (Usa) | 31 | 3 |
| Smith & Nephew, Inc. | 27 | 6 |
| Smith & Nephew Inc., Endoscopy Division | 1 | 30 |
| Wrightmedicaltechnologyinc | 31 | 0 |
| Stryker Howmedica Osteonics Corp. | 0 | 30 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2017 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver
Product Code: 288211
Product Usage:
The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the antero Terminated |
HWC | K083096 K091694 +1 |
| Mar 9, 2017 | Smith & Nephew, Inc. D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes:
(a) 2.4MM X 10MM, RES 74692410
(b) 2.4MM X 12MM, RES 74692412
(c) 2.4MM X 16MM, RES 74692416
(d) 2.4MM X 22MM, RES 74692422 Terminated |
HWC | K132296 |
| Mar 9, 2017 | Smith & Nephew, Inc. D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420
Orthopedic Terminated |
HWC | K132296 |
| Mar 9, 2017 | Smith & Nephew, Inc. D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816
Orthopedic Terminated |
HWC | K132296 |
| Jan 10, 2017 | Zimmer Biomet, Inc. 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw Terminated |
HWC | K121589 |
| Jan 6, 2017 | Trilliant Surgical Ltd. Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O
The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of Terminated |
HWC | K153338 |
| Nov 17, 2016 | Trilliant Surgical Ltd. Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29 Trilliant Surgical, LTD" Terminated |
HWC | K112737 |
| Nov 8, 2016 | Wright Medical Technology, Inc. Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S Terminated |
HWC | None listed |
| Nov 8, 2016 | Wright Medical Technology, Inc. ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538 Terminated |
HWC | K102429 |
| Sep 19, 2016 | OrthoPediatrics Corp 3.5mm Bowed Locking Compression Femur Plates, 18 hole
Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and in Terminated |
HWC | K083286 |
| Sep 19, 2016 | OrthoPediatrics Corp 3.5mm Bowed Locking Compression Femur Plates, 14 hole
Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and in Terminated |
HWC | K083286 |
| Jul 21, 2016 | Integra LifeSciences Corp. Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only,
Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction. Terminated |
HWC | K071639 |
| Jul 21, 2016 | Ortho Solutions Inc FPS 35mm x 3.5 mm non-locking screw Terminated |
HWC | K111678 |
| Jul 11, 2016 | Synthes (USA) Products LLC 3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, Screw, Fixation Bone
Product Usage:
Intended for fracture fixation of large bones and large bone fragments, such a Terminated |
HWC | K021932 |
| Jul 11, 2016 | Synthes (USA) Products LLC 4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone
Product Usage:
Intended for fracture fixation of large bones and large bone fragments, such Terminated |
HWC | K021932 |
| Jul 11, 2016 | Synthes (USA) Products LLC 4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone
Product Usage:
Intended for fracture fixation of large bones and large bone fragments, such as femoral neck Terminated |
HWC | K021932 |
| Jul 11, 2016 | Synthes (USA) Products LLC 4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone
Product Usage:
Intended for fracture fixation of large bones and large bone fragments, such as f Terminated |
HWC | K021932 |
| Jul 11, 2016 | Synthes (USA) Products LLC 7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620, Plate, Fixation Bone
Product Usage:
Intended for fracture fixation of large bones and large bone fragments, such a Terminated |
HWC | K021932 |
| Jul 11, 2016 | Synthes (USA) Products LLC 6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Screw, Fixation Bone
Product Usage:
Intended for fracture fixation of large bones and large bone fragments, such as femoral n Terminated |
HWC | K021932 |
| Jul 11, 2016 | Synthes (USA) Products LLC 6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation Bone
Product Usage:
Intended for fracture fixation of large bones and large bone fragments, such as femoral n Terminated |
HWC | K021932 |
| May 26, 2016 | Biomet, Inc. Various trauma and sports medicine instruments and implants.
Screw, fixation, bone. Terminated |
HWC | K992367 |
| May 16, 2016 | Zimmer Manufacturing B.V. Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507
Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 75 mm Length 47115507507
Herbert Cannulated Bone Terminated |
HWC | K143165 |
| May 16, 2016 | Zimmer Manufacturing B.V. Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length 00114205020
Mini Magna-Fx Cannulated Screw Fixation System Small Cannulated Bon Terminated |
HWC | K142442 |
| May 16, 2016 | Zimmer Manufacturing B.V. Zimmer Plates and Screws (ZPS)
4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200
4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400
4.0 mm Cancellous Screw Fully Thread Terminated |
HWC | K112885 |
| May 16, 2016 | Zimmer Manufacturing B.V. Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length
47234702116 Terminated |
HWC | K111447 |
| May 16, 2016 | Zimmer Manufacturing B.V. Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801 Terminated |
HWC | K082527 |
| May 16, 2016 | Zimmer Manufacturing B.V. Zimmer Plates and Screws (ZPS)
2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401 Terminated |
HWC | K063303 |
| May 16, 2016 | Zimmer Manufacturing B.V. Zimmer Plates and Screws (ZPS)
3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001
3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401
3.5 mm Cortical Screw SelfTapping, 16 mm Lengt Terminated |
HWC | K060710 |
| May 6, 2016 | MicroAire Surgical Instruments, LLC Endotine Transbleph 3.5 (CFD-080-0167) Terminated |
HWC | K042796 |
| Apr 18, 2016 | Stryker Howmedica Osteonics Corp. VariAx Compression Plating System Terminated |
HWC | K130009 |
| Apr 4, 2016 | Synthes (USA) Products LLC 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile;
Catalog ID # 02.221.462S
Indicated for fixation of various long bones. Terminated |
HWC | K041533 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 56 consists of all product under product code: HWC and same usage:
Item no:
47234702032 PERI SCR 3.5MM X 32MM STE
47234702018 PERI SCR. 3.5MM X 18MM ST
47234702020 PERI SCR. 3.5MM X 20MM ST
4 Terminated |
HWC | K111447 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 52 consists of product code: HWC and same usage:
Item no:
525004530 NEXGEN OSTEOTOMY CORT BON
525004540 NEXGEN OSTEOTOMY CORT BON
525006545 NEXGEN OSTEOTOMY CORT BON
525006560 NEXGEN OSTEOTOM Terminated |
HWC | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 46 consists of all product under product code: HWC and same usage:
Item no:
114204012 MINI MAGNA-FX CANN SCREW
114204016 MINI MAGNA-FX CANN SCREW
114204020 MINI MAGNA-FX CANN SCREW
114204024 Terminated |
HWC | K142442 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 44 consists of all product under product code: HWC and same usage:
Item no:
114607099 MAGMA-FX CANN SCREW 7.0MM
114604099 MAGNA FX CANN SCREW 7.0MM
114603000 MAGNA-FX CANN SCREW 7.0MM
114603 Terminated |
HWC | K142442 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 32 consists of all product under product code: HWC and same usage:
Item no:
47115401200 HERBERT BONE SCREW, 3.0MM
47115401400 HERBERT BONE SCREW, 3.0MM
47115401600 HERBERT BONE SCREW, 3.0MM
Terminated |
HWC | K143165 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 18 consists of all product under product code: HWC and same usage:
Item no:
47248001441 CANC SCR 4.0MM X 14MM FUL
47248001641 CANC SCR 4.0MM X 16MM FUL
47248001840 CANC SCR 4.0MM X 18MM
4724 Terminated |
HWC | K112885 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 13 consists of all product under product code HWC
, and same usage:
Item no:
47486510002 6.5 X 100 CANC SCREW, 32M
Product Usage:
A smooth or threaded metallic bone fixation fastener is a de Terminated |
HWC | K112885 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 10consists of all product under product code HWC, and same usage:
Item no:
47484502601 4.5 X 26 CORT SCREW SELF
Product Usage:
A smooth or threaded metallic bone fixation fastener is a de Terminated |
HWC | K112885 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 8 consists of all products under product code HWC, and same usage:
Item no:
47483501201 3.5MM CORT. SCREW 12MM LN
47483501401 3.5MM CORT. SCREW 14MM LN
47483501601 3.5MM CORT. SCREW 16MM LN
4 Terminated |
HWC | K060710 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 7 consists of all products under product code HWC, and same usage:
Item no:
47234801435 3.5MM CORT SCR X 14MM
47234801635 3.5MM CORT SCR X 16MM
47234806535 3.5MM CORT SCR X 65MM
47234807035 Terminated |
HWC | K111447 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 6 consists of all products under product code HWC, and same usage:
Item no:
47493501001 3.5 X 10 CORT SCREW SELFT
47493501801 3.5 X 18 CORT SCREW SELFT
Product Usage:
A smooth or threaded m Terminated |
HWC | K082527 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 5 consists of all products under product code HWC, and same usage:
Item no:
47482701001 2.7MM CORT. SCREW 10MM, S
47482701201 2.7MM CORT. SCREW 12MM, S
47482701401 2.7MM CORT. SCREW 14MM, Terminated |
HWC | K063303 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 4 consists of all products under product code HWC, and same usage:
Item no:
47482002603 2.0 X 26 CORT SCREW CRUCI
47482002803 2.0 X 28 CORT SCREW CRUCI
47482003203 2.0 X 32 CORT SCREW CRUCI
Terminated |
HWC | K112885 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 1 consists of all product under , product code: JWH and same usage:
Item no:
47481500601 1.5 X 6 CORT SCREW HEX/SE
Product Usage: A smooth or threaded metallic bone fixation fastener is a de Terminated |
HWC | None listed |
| Dec 9, 2015 | Zimmer Biomet, Inc. Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14 mm Length.
Indicated for temporary internal fixation and Terminated |
HWC | K040593 K042598 |
| Dec 9, 2015 | In2Bones, SAS IBS - Osteosynthesis screws for bone fixation Model S25 ST014. Terminated |
HWC | K131920 |
| Nov 20, 2015 | Pega Medical Inc. SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System.
This instrument is included in the Free Gliding SCFE Screw System instrument tray. This Terminated |
HWC | K131591 |
| Nov 2, 2015 | Synthes (USA) Products LLC 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly Terminated |
HWC | K012114 K040588 +4 |
| Oct 6, 2015 | Ortho Solutions Inc Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile
Orthopaedic Bone Terminated |
HWC | K141784 |
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