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) |
|---|---|---|---|
| Mar 26, 2021 | Nextremity Solutions InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis. Terminated |
HWC | None listed |
| Dec 17, 2020 | Biomet, Inc. RapidFire Clip, Item Number 95-0154 - Product Usage:
Fixation of Craniofacial bone. Terminated |
HWC | K031751 |
| Dec 17, 2020 | Biomet, Inc. 6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929,
110009934, 110009935, 110009936, 110009993, 110009994,
110009996, 110009998, 1100100 Terminated |
HWC | K140891 |
| Dec 17, 2020 | Biomet, Inc. 4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810,
110009821, 110009825, 110009852 - Product Usage: Fracture fixationof small bones, smal Terminated |
HWC | K140891 |
| Dec 17, 2020 | Biomet, Inc. 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787
110009790, 110009794, 110009796, 110009798, 110009800 - Product Usage: Fracture fixationof Terminated |
HWC | K143188 |
| May 14, 2020 | Biomet Biomet 8.0 Cannulated Screw Tap-Bone fixation screw
Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal he Terminated |
HWC | K140891 |
| May 14, 2020 | Biomet Biomet 6.5 Cannulated Screw Tap - Bone fixation screw,
Item Number: 110008466 - Product Usage:
Intended for temporary internal fixation and stabilization of osteotomies and fractures during the nor Terminated |
HWC | K140891 |
| Feb 24, 2020 | Nextremity Solutions Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile.
REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments w Terminated |
HWC | K110445 |
| Nov 11, 2019 | Nextremity Solutions Stratum MDS Screw 3.5x50mm ST
Part Number: STRM-MDS-3550ST Terminated |
HWC | K182201 |
| Nov 11, 2019 | Nextremity Solutions Stratum MDS Screw 3.5x48mm ST
Part Number: STRM-MDS-3548ST Terminated |
HWC | K182201 |
| Nov 11, 2019 | Nextremity Solutions Stratum MDS Screw 3.5x46mm ST
Part Number: STRM-MDS-3546ST Terminated |
HWC | K182201 |
| Oct 10, 2019 | Zimmer Biomet, Inc. NCB-PH Plate with 4/5/7 Lock Holes, Item Nos. 0202262104
0202262105
0202262107 Terminated |
HWC | K081759 |
| Oct 1, 2019 | Arthrex, Inc. Low Profile Screw, 4.5 x 20 mm
The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixati Terminated |
HWC | K141735 |
| Sep 19, 2019 | CrossRoads Extremity Systems, LLC MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm Terminated |
HWC | K173710 |
| Mar 29, 2019 | PROVIDENCE MEDICAL TECHNOLOGIES Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the d Terminated |
HWC | K121713 |
| Mar 28, 2019 | Zimmer Biomet, Inc. T7 Driver Solid AO (Part Number 110018541)
Product Usage:
The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or Terminated |
HWC | K142658 |
| Mar 28, 2019 | Zimmer Biomet, Inc. T7 Driver Cannulated AO (Part Number 110018531)
Product Usage:
The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis Terminated |
HWC | K142658 |
| Mar 1, 2019 | Integra Limited Integra bioBLOCK Resorbable subtaler Implant, 12mm
Catalog Number: 040012 - Product Usage:
The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of Terminated |
HWC | K051611 |
| Mar 1, 2019 | Integra Limited Integra bioBLOCK Resorbable subtaler Implant, 11mm
Catalog Number: 040011 - Product Usage:
The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of Terminated |
HWC | K051611 |
| Mar 1, 2019 | Integra Limited Integra bioBLOCK Resorbable subtaler Implant, 10mm
Catalog Number: 40010 - Product Usage:
The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of Terminated |
HWC | K051611 |
| Sep 12, 2018 | Synthes (USA) Products LLC 3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118
DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures Terminated |
HWC | K050636 |
| Jul 20, 2018 | Zimmer Biomet, Inc. Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629 Terminated |
HWC | K982497 |
| Jul 20, 2018 | Zimmer Biomet, Inc. Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612 Terminated |
HWC | K982497 |
| Jul 19, 2018 | Trilliant Surgical, LLC Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Small Joint Reaming System, Model 311-00-001. The firm name on the label is Trilliant Surgical Ltd, Ho Terminated |
HWC | None listed |
| Jul 19, 2018 | Trilliant Surgical, LLC Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Ankle Plating System, Model 320-01-100. The firm name on the label is Trilliant Surgical Ltd, Terminated |
HWC | K160177 |
| Jul 19, 2018 | Trilliant Surgical, LLC Instructions for Use and Surgical Cleaning and Sterilization Protocol for:
(1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System, Model 215-00-001; and
(2) Trilliant Surgical Ltd Large Cann Terminated |
HWC | K153338 |
| Jul 19, 2018 | Trilliant Surgical, LLC Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd 3S Hemi Toe Implant System, Model 111-00-001. The firm name on the label is Trilliant Surgical Ltd, H Terminated |
HWC | K072922 |
| Jul 19, 2018 | Trilliant Surgical, LLC Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Two-Step Hammertoe Implant System, Model 214-00-001. The firm name on the label is Trilliant Surgical Terminated |
HWC | K122959 |
| Jul 19, 2018 | Trilliant Surgical, LLC Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Plating System, Model 310-01-100. The firm name on the label is Trilliant Surgical Ltd, Houst Terminated |
HWC | K121452 K123525 +1 |
| Jul 19, 2018 | Trilliant Surgical, LLC Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Disco Subtalar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd Terminated |
HWC | K111834 |
| Jul 19, 2018 | Trilliant Surgical, LLC Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Ho Terminated |
HWC | K103183 |
| Jul 19, 2018 | Trilliant Surgical, LLC Instructions for Use and Surgical Cleaning and Sterilization Protocol for:
(1) Trilliant Surgical Ltd Tiger Headless Cannulated Screw System, Model 212-00-001; and
(2) Combination Tiger Cannulated/T Terminated |
HWC | K112737 K153338 |
| Jul 19, 2018 | Trilliant Surgical, LLC Instructions for Use and Surgical Cleaning and Sterilization Protocol for:
(1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-00-001; and
(2) Combination Tiger/Tiger Headless Cannulated Terminated |
HWC | K081510 K112737 +1 |
| Jul 16, 2018 | In2bones USA, LLC CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones
Product Usage:
The In2Bones USA LLC, CoLink Plating System is indicated for stabilization and fixation of fractures, revision Terminated |
HWC | K163293 |
| Jul 16, 2018 | In2bones USA, LLC CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones
Product Usage:
The In2Bones USA LLC, CoLink Plating System is indicated for stabilization and fixation of fractures, revisio Terminated |
HWC | K163293 |
| Mar 28, 2018 | Zimmer Biomet, Inc. Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee. Terminated |
HWC | K982497 |
| Mar 28, 2018 | Zimmer Biomet, Inc. Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the ankle/foot and knee. Terminated |
HWC | K041274 |
| Mar 28, 2018 | Zimmer Biomet, Inc. Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment procedures in the ankle/foot and knee. Terminated |
HWC | K041274 |
| Mar 28, 2018 | Zimmer Biomet, Inc. Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment procedures in the ankle/foot and knee. Terminated |
HWC | K041274 |
| Mar 28, 2018 | Zimmer Biomet, Inc. Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee. Terminated |
HWC | K041274 |
| Mar 28, 2018 | Zimmer Biomet, Inc. Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee. Terminated |
HWC | K982497 |
| Mar 20, 2018 | Smith & Nephew, Inc. D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERILE R Terminated |
HWC | K132296 |
| Dec 7, 2017 | Zimmer Biomet, Inc. 6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910)
Product Usage:
The 6.5/8.0mm Cannulated Screw System is part of a series of cannulated sc Terminated |
HWC | K140891 |
| Nov 17, 2017 | Stryker Corporation STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile. Terminated |
HWC | K972233 |
| Oct 10, 2017 | ORTHO SOLUTIONS, LTD. SYSTEM 26. Part Numbers:
OS900035-NS;
OS900036-NS;
OS900037-NS;
OS900038-NS;
OS900040-NS;
OS900041-NS;
OS900042-NS;
OS900043-NS;
OS900047-NS;
OS900048-NS;
OS900045-NS;
OS900046-NS;
OS900050-NS;
OS9000 Terminated |
HWC | K163489 |
| Sep 18, 2017 | MicroPort Orthopedics Inc. MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R
Product Usage:
MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain a Terminated |
HWC | K952296 |
| May 12, 2017 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek LATARJET EXPERIENCE Extraction Driver
Product Code: 288216
Product Usage:
The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroin Terminated |
HWC | K083096 K091694 +1 |
| May 12, 2017 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek LATARJET EXPERIENCE Top Hat Tap
Product Code: 288203
Product Usage:
The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior Terminated |
HWC | K083096 K091694 +1 |
| May 12, 2017 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill
Product Code: 288202
Product Usage:
The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the ante Terminated |
HWC | K083096 K091694 +1 |
| May 12, 2017 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek LATARJET EXPERIENCE Coracoid Drill
Product Code: 288201
Product Usage:
The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferi Terminated |
HWC | K083096 K091694 +1 |
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