Panels › Orthopedic › Product code HWC · Class 2
Screw, Fixation, Bone
Regulation 888.3040
23510(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) |
|---|---|---|---|
| Oct 14, 2026 | In2bones USA, LLC REF: P65 ST862
CoLag SCREW, FT, 6.7X62.5 mm Open, Classified |
HWC | K170518 |
| Jun 9, 2026 | Medartis AG Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation Open, Classified |
HWC | K202589 |
| Mar 20, 2026 | I.T.S. GmbH HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31 Open, Classified |
HWC | K131722 |
| Mar 20, 2026 | I.T.S. GmbH I.T.S. Screw System with the below descriptions and corresponding article numbers.
1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404 Open, Classified |
HWC | K060156 |
| Mar 10, 2026 | Medartis AG Brand Name: APTUS
Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg
Model/Catalog Number: A-5850.16/1
Software Version: Not applicable.
Product Description: The APTUS fixation systems are used for frac Open, Classified |
HWC | K091479 |
| Mar 10, 2026 | Medartis AG Brand Name: APTUS
Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg
Model/Catalog Number: A-5750.16/1
Software Version: Not applicable.
Product Description: The APTUS fixation systems are used for frac Open, Classified |
HWC | K051567 |
| Dec 18, 2025 | Smith & Nephew, Inc. BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. Open, Classified |
HWC | K080358 K142948 |
| May 14, 2024 | Medartis Inc. APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system. Open, Classified |
HWC | K091479 |
| May 10, 2024 | TriMed Inc. TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only
TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only Open, Classified |
HWC | K234040 |
| May 10, 2024 | TriMed Inc. TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only
TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only Open, Classified |
HWC | K234040 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-018-10 Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-018-08 Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-018-06 Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-018-04 Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-017-10 Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-017-08 Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-017-06 Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractu Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 16 Holes, 236 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 47-2357-018-14 Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fracture Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 7-2357-018-04 Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 16 Holes, 236 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fracture Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fracture Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fracture Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fracture Open, Classified |
HWC | K070906 |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Open, Classified |
HWC | K070906 |
| Mar 20, 2024 | In2Bones, SAS I.B.S 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180 Open, Classified |
HWC | K131920 |
| Mar 20, 2024 | In2Bones, SAS I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175 Open, Classified |
HWC | K131920 |
| Dec 23, 2022 | Acumed LLC Dual-Trak Clavicle Screws
Part Number/Part Description:
40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw
40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw
40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw
40-0 Open, Classified |
HWC | K221333 |
| Dec 23, 2022 | Acumed LLC AcuTwist Acutrak Compression Screws
Part Number/Part Description:
AI-0010-S 10mm AcuTwist Acutrak Compression Screw
AI-0012-S 12mm AcuTwist Acutrak Compression Screw
AI-0014-S 14mm AcuTwist Acutrak Co Open, Classified |
HWC | K221333 |
| Dec 23, 2022 | Acumed LLC Acutrak 2
Part Number/Part Description:
30-0021 25.0mm Acutrak 2 - 5.5 Screw
30-0021-S 25.0mm Acutrak 2 - 5.5 Screw
30-0023 30.0mm Acutrak 2 - 5.5 Screw
30-0023-S 30.0mm Acutrak 2 - 5.5 Screw
30-0025 Open, Classified |
HWC | K221333 |
| Dec 23, 2022 | Acumed LLC Part Number/Part Description:
30-0033-S 30mm Acutrak Fusion Device 6mm Nose
AM-0025-S 25.0mm Acutrak 4/5 Bone Screw
AM-0030-S 30.0mm Acutrak 4/5 Bone Screw
AM-0035-S 35.0mm Acutrak 4/5 Bone Open, Classified |
HWC | K221333 |
| Mar 9, 2022 | Acumed LLC 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012 Completed |
HWC | K123890 |
| Mar 9, 2022 | Acumed LLC 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010 Completed |
HWC | K123890 |
| Feb 10, 2022 | Nextremity Solutions Nextra Hammertoe Correction System Driver
SKU: NX-DR
Orthopedic surgical instrument Terminated |
HWC | K110445 |
| Feb 10, 2022 | Nextremity Solutions Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut
SKU: NX-3532K-SC
Orthopedic surgical instrument Terminated |
HWC | K110445 |
| Feb 10, 2022 | Nextremity Solutions Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit
SKU: NX-3532K
Orthopedic surgical instrument Terminated |
HWC | K110445 |
| Feb 10, 2022 | Nextremity Solutions Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut
SKU: NX-4532K-SC
Orthopedic surgical instrument Terminated |
HWC | K110445 |
| Feb 10, 2022 | Nextremity Solutions Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit
SKU: NX-4532K
Orthopedic surgical instrument Terminated |
HWC | K110445 |
| Jan 13, 2022 | Nextremity Solutions Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe
SKU: CH-STD-KT Terminated |
HWC | K200840 K213530 |
| Jan 13, 2022 | Nextremity Solutions Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes
SKU: CH-MINI-KT Terminated |
HWC | K200840 K213530 |
| Nov 17, 2021 | Medshape, INC. DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile Open, Classified |
HWC | K203381 |
| Oct 7, 2021 | SCIENCE & BIO MATERIALS ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605 Completed |
HWC | K070507 |
| Sep 20, 2021 | Smith & Nephew, Inc. 6.5MMX165MM CANNULATED SCREW Terminated |
HWC | K060736 |
| Mar 26, 2021 | Nextremity Solutions InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis. Terminated |
HWC | None listed |
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