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) |
|---|---|---|---|
| Sep 18, 2015 | Synthes (USA) Products LLC Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixatio Terminated |
HWC | K110592 |
| Aug 26, 2015 | Trilliant Surgical Ltd. Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System and the Tiger Headless Terminated |
HWC | K081510 K112737 |
| Aug 19, 2015 | Trilliant Surgical Ltd. 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE
Product Usage:
The Tiger Cannulated Screw Fixation System i Terminated |
HWC | K081510 |
| Jul 1, 2015 | Biomet, Inc. Gentle Threads Interference Screw 9x35mm Full Thread.
An interference fixation screw for use in soft tissue reattachment procedures Terminated |
HWC | K982497 |
| Jul 1, 2015 | Biomet, Inc. Gentle Threads Interference Screw 10x25mm Round Head.
An interference fixation screw for use in soft tissue reattachment procedures. Terminated |
HWC | K041274 |
| Jun 26, 2015 | Pega Medical Inc. Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273. Terminated |
HWC | K131591 |
| Jun 15, 2015 | Synthes, Inc. 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, Terminated |
HWC | K000684 K050683 |
| May 18, 2015 | Wright Medical Technology, Inc. PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONTENTS 1 EACH, RX ONLY Terminated |
HWC | None listed |
| May 18, 2015 | Wright Medical Technology, Inc. PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED, REF 45304013, CONTENTS 1 EACH, RX ONLY Terminated |
HWC | None listed |
| May 18, 2015 | Wright Medical Technology, Inc. PHALINX (TM) HAMMERTOE HANDLE, SIZE: SMALL, STYLE: ANGLED, REF 45304012, CONTENTS 1 EACH, RX ONLY Terminated |
HWC | None listed |
| May 18, 2015 | Wright Medical Technology, Inc. PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CONTENTS 1 EACH, RX ONLY Terminated |
HWC | None listed |
| Mar 25, 2015 | In2Bones, SAS DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only.
Interphalangeal implant. Terminated |
HWC | K132912 |
| Mar 25, 2015 | In2Bones, SAS DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only.
Interphalangeal implant. Terminated |
HWC | K132912 |
| Mar 24, 2015 | Flower Orthopedics Corporation Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Terminated |
HWC | K123562 K131657 |
| Oct 30, 2014 | Medartis, Inc. APTUS Ulna Shortening 2.5
Product Usage:
APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna. Terminated |
HWC | K141232 |
| Sep 22, 2014 | Instratek, Incorporated Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System Terminated |
HWC | K120493 |
| Aug 26, 2014 | Zimmer, Inc. Trauma Large Screws:
CANN BONE SCREW 7.0MMX100MMLG
CANN BONE SCREW 7.0X105LG
CANN BONE SCREW 7.0X105LG
CANN BONE SCREW 7.0MMX105MMLG
CANN BONE SCREW 7.0X110LG
CANN BONE SCREW 7.0X110LG
CANN BONE SCREW Terminated |
HWC | K111447 |
| Aug 19, 2014 | Synthes, Inc. Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set Terminated |
HWC | K951304 |
| Aug 16, 2014 | Zimmer, Inc. 4.0 mm Cancellous Screw, Partially Threaded
Sterile
Zimmer Terminated |
HWC | K112885 |
| Aug 16, 2014 | Zimmer, Inc. 4.5 mm Malleolar Screw
Sterile
zimmer Terminated |
HWC | K112885 |
| Aug 16, 2014 | Zimmer, Inc. 6.5 mm Cancellous Screw Fully Threaded
Sterile
zimmer Terminated |
HWC | K112885 |
| Aug 16, 2014 | Zimmer, Inc. 6.5 mm Cancellous Screw 32 mm Thread Length
Sterile
zimmer Terminated |
HWC | K112885 |
| Aug 16, 2014 | Zimmer, Inc. 6.5 mm Cancellous Screw 16 mm Thread Length
Sterile
zimmer Terminated |
HWC | K112885 |
| Aug 16, 2014 | Zimmer, Inc. 6.5 mm Cancellous Screw Fully Threaded
Sterile
zimmer Terminated |
HWC | K112885 |
| Aug 16, 2014 | Zimmer, Inc. Magna-Fx Cannulated Screw Fixation System
Cannulated Bone Screw
Sterile
zimmer Terminated |
HWC | K112885 |
| Aug 16, 2014 | Zimmer, Inc. Magna-Fx Cannulated Screw Fixation System
Bone Screw Fully Threaded
Sterile
zimmer Terminated |
HWC | K112885 |
| Jul 30, 2014 | Small Bone Innovations Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments
Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fr Terminated |
HWC | K052576 |
| Jul 10, 2014 | Zimmer Manufacturing B.V. Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary intern Terminated |
HWC | K934765 |
| Jul 2, 2014 | Synthes, Inc. Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthope Terminated |
HWC | None listed |
| Jun 2, 2014 | Integra LifeSciences Corporation Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to Terminated |
HWC | K073375 |
| Feb 20, 2014 | Zimmer, Inc. 3.5 X 10 CORT SCREW SELFT
3.5 X 12 CORT SCREW SELFT
3.5 X 14 CORT SCREW SELFT
3.5 X 16 CORT SCREW SELFT
3.5 X 18 CORT SCREW SELFT
3.5 X 20 CORT SCREW SELFT
3.5 X 22 CORT SCREW SELFT
3.5 X 24 CORT SCRE Terminated |
HWC | K082527 |
| Feb 20, 2014 | Zimmer, Inc. 1.5 X 6 CORT SCREW HEX/SE
2.0 X 6 CORT SCREW HEX/SE
2.0 X 10 CORT SCREW CRUCI
2.0 X 12 CORT SCREW CRUCI
2.0 X 14 CORT SCREW CRUCI
2.0 X 16 CORT SCREW HEX/S
2.0 X 16 CORT SCREW CRUCI
2.0 X 18 CORT SCRE Terminated |
HWC | K060710 K063303 +1 |
| Feb 20, 2014 | Zimmer, Inc. 2.7 X 6 CORT SCREW/SELFTA
2.7 X 7 CORT SCREW/SELFTA
2.7 X 8 CORT SCREW/SELFTA
2.7 X 9 CORT SCREW/SELFTA
2.7 X 10 CORT SCREW/SELFT
2.7 X 12 CORT SCREW/SELFT
2.7 X 14 CORT SCREW/SELFT
2.7 X 16 CORT SCRE Terminated |
HWC | K082527 K083654 |
| Feb 20, 2014 | Zimmer, Inc. PERI SCR. 3.5MM X 10MM
PERI SCR. 3.5MM X 12MM
PERI SCR. 3.5MM X 14MM
PERI SCR 3.5MM X 44MM STE
PERI SCR. 3.5MM X 65MM
PERI. SCR 4.0MM X24MM
PERI. SCR 4.0MM X40MM
PERI SCR. 4.0MMX14 Terminated |
HWC | K112885 |
| Feb 20, 2014 | Zimmer, Inc. HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S Terminated |
HWC | K792022 |
| Feb 20, 2014 | Zimmer, Inc. NEXGEN OSTEOTOMY CORT BON. Item codes starting with 0052500 Terminated |
HWC | None listed |
| Feb 20, 2014 | Zimmer, Inc. HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500 and 0011520. Terminated |
HWC | K792022 |
| Feb 20, 2014 | Zimmer, Inc. Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461. Terminated |
HWC | None listed |
| Feb 6, 2014 | OrthoPediatrics Corp 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm
Part No. 00-0903-2620
OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatr Terminated |
HWC | None listed |
| Dec 11, 2013 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw
Howmedica Osteonics Corp.
Stryker France
Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40 mm l Terminated |
HWC | K894124 |
| Nov 26, 2013 | Synthes USA HQ, Inc. 3.7mm and 5.0mm Dynamic Locking Screw (DLS)
Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bon Terminated |
HWC | K110592 |
| Nov 19, 2013 | Ebi, Llc BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile.
Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation Terminated |
HWC | K123549 |
| Oct 17, 2013 | Synthes USA HQ, Inc. Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle. Terminated |
HWC | K081071 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689
Biodegradable suture anchor Terminated |
HWC | K031685 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690
Biodegradable suture anchor Terminated |
HWC | K031685 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783
Biodegradable suture anchor Terminated |
HWC | K031685 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774
Biodegradable suture anchor Terminated |
HWC | K031685 |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775
Biodegradable suture anchor Terminated |
HWC | K031685 |
| Aug 27, 2013 | Stryker Howmedica Osteonics Corp. Stryker
1) Asnis III Cannulated Screw REF 604640
4.0x40mm TL 13.5mm
2) Asnis III Cannulated Screw REF 604642S
4.0x42mm TL 14mm, sterile
Product Usage: The Asnis III Cannulated Screw System is inte Terminated |
HWC | K000080 |
| Aug 9, 2013 | OrthoPediatrics Corp 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw. Terminated |
HWC | K083286 |
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