510(k) · Cleared
ClearedLarge Screws Range
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newclip Technics · HWC Screw, Fixation, Bone
Cleared on Jun 3, 2016 as substantially equivalent to K000080 (Howmedica Osteonics Corp., 2000) and 3 other predicates after a 92-day review. Its family tree reaches back 5 generations to 1996. 6 later devices descend from it.
- Decided
- Jun 3, 2016
- Review
- 92 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K962823 (1996). 12 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 4 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 3 generations backK011821 Modification to the I.C.O.S ScrewNew Deal, S.A. · 2001
- 2 generations backK050346 Stabilization ScrewNew Deal, S.A. · 2005 · Recalled
- 1 generation backK071639 Qwix Positioning ScrewNewdeal Sas · 2007 · Recalled
- This deviceK160617 Large Screws RangeNewclip Technics · 2016
- Descendant · cites it directly · 4 of its ownK172596 Large Screws RangeNewclip Technics · 2017
- Descendant · 2 generations on · 3 of its ownK173641 Activ AnkleNewclip Technics · 2018
- Descendant · 3 generations on · 0 of its ownK261511 Xpert AnkleNewclip Technics · 2026
- Descendant · 3 generations on · 0 of its ownK221395 Footmotion Plating SystemNewclip Technics · 2022
- Descendant · 3 generations on · 0 of its ownK213214 Xpert WristNewclip Technics · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K172596Large Screws RangeNewclip Technics · 2017 · cites it directly4descendants
- K173641Activ AnkleNewclip Technics · 2018 · 2 generations on3descendants
- K261511Xpert AnkleNewclip Technics · 2026 · 3 generations on0descendants
- K221395Footmotion Plating SystemNewclip Technics · 2022 · 3 generations on0descendants
- K213214Xpert WristNewclip Technics · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −4 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −3 | K011821 | Modification to the I.C.O.S Screw | New Deal, S.A. | 2001 | — |
| −2 | K050346 | Stabilization Screw | New Deal, S.A. | 2005 | 4 |
| −1 | K071639 | Qwix Positioning Screw | Newdeal Sas | 2007 | 1 |
| 0 (this device) | K160617 | Large Screws Range | Newclip Technics | 2016 | — |
| +1 | K172596 | Large Screws Range | Newclip Technics | 2017 | — |
| +2 | K173641 | Activ Ankle | Newclip Technics | 2018 | — |
| +3 | K261511 | Xpert Ankle | Newclip Technics | 2026 | — |
| +3 | K221395 | Footmotion Plating System | Newclip Technics | 2022 | — |
| +3 | K213214 | Xpert Wrist | Newclip Technics | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K000080 | Asnis Iii Cannulated Screw SystemSummary page 4…y predicate or legally marketed devices which are substantially equivalent: • Asnis III Cannulated Screw System of Howmedica Osteonics Corp. (K000080 and K024060) Secondary predicate or legally marketed devices which are substantially equivalent: • Qwix… | 2000 |
| * | K024060 | Modification to Asnis Iii Cannulated Screw SystemSummary page 4…or legally marketed devices which are substantially equivalent: • Asnis III Cannulated Screw System of Howmedica Osteonics Corp. (K000080 and K024060) Secondary predicate or legally marketed devices which are substantially equivalent: • Qwix fixation scr… | 2002 |
| * | K071639 | Qwix Positioning ScrewSummary page 4…Secondary predicate or legally marketed devices which are substantially equivalent: • Qwix fixation screws and Stabilization screw of Newdeal SAS (K071639 and K050346) Page 2 of 3… | 2007 |
| * | K050346 | Stabilization ScrewSummary page 4…te or legally marketed devices which are substantially equivalent: • Qwix fixation screws and Stabilization screw of Newdeal SAS (K071639 and K050346) Page 2 of 3… | 2005 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K172596 (Newclip Technics, 2017) has gone furthest, with 4 descendants of its own.
- 20 other devices also cite its predicate K000080.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Large Screws range is intended for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.
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/K160617 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160617: Large Screws Range.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160617
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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