510(k) · Cleared
ClearedCannulated Screws Neoortho
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neoortho Produtos Ortopedicos S/A · HWC Screw, Fixation, Bone
Cleared on Jun 27, 2017 as substantially equivalent to K142057 (Infix Medical, LLC, 2015) and 1 other predicate after a 257-day review. Its family tree reaches back 9 generations to 2000.
- Decided
- Jun 27, 2017
- Review
- 257 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K000684 (2000). 73 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 9 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 5 generations between
- 3 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 2 generations backK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · Recalled
- 1 generation backK142057 Infix Cannulated Screw SystemInfix Medical, LLC · 2015
- This deviceK162874 Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A · 2017
Show all 9 generations
- Root · 9 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 8 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 7 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 6 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 5 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 4 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 3 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 2 generations backK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · Recalled
- 1 generation backK142057 Infix Cannulated Screw SystemInfix Medical, LLC · 2015
- This deviceK162874 Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −8 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −7 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −6 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −5 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −4 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −3 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −2 | K111678 | Ortho Solutions Extremity Fixation Implants for Osteosysnthesis | Ortho Solutions Limited | 2012 | 1 |
| −1 | K142057 | Infix Cannulated Screw System | Infix Medical, LLC | 2015 | — |
| 0 (this device) | K162874 | Cannulated Screws Neoortho | Neoortho Produtos Ortopedicos S/A | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 8 | 0 |
| 1997 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 7 | 0 |
| 2003 | 2 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HWC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K142057 | Infix Cannulated Screw SystemSummary page 5…regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices: K142057, Infix Medical LLC, Infix Cannulated Screw System K050636, Synthes (USA), Synthes (USA) 3.0 mm Headless Compression Screws The… | 2015 |
| * | K050636 | Synthes 3.0MM Headless Compression ScrewsSummary page 5…antially equivalent in indications and design principles to the following legally marketed predicate devices: K142057, Infix Medical LLC, Infix Cannulated Screw System K050636, Synthes (USA), Synthes (USA) 3.0 mm Headless Compression Screws The subject device and the predicate devices have the same int… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 14 of the 73 ancestors have a recall of any class.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Cannulated Screws Neoortho are generally intended for fracture fixation of various bones and bone fragments, such as femoral neck, intercondylar femoral, malleolus, pilon tibial, calcaneus, talus, tibial plateau, tarsal, metatarsal, wrist, metacarpal, carpal, scaphoid and radius fracture. The Cannulated Screws Neoortho are also intended for fixation arthrodesis, iliosacral dislocations, and hallux valgus corrections. Accessories implants: The washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162874 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162874: Cannulated Screws Neoortho.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162874
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026