510(k) · Cleared
ClearedCannulated Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fournitures Hospitalieres Industrie · HWC Screw, Fixation, Bone
Cleared on Jun 14, 2007 as substantially equivalent to K041456 (Fournitures Hospitalieres Industrie, 2004) and 4 other predicates after a 101-day review. Its family tree reaches back 2 generations to 1979. 4 later devices descend from it.
- Decided
- Jun 14, 2007
- Review
- 101 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K792022 (1979). 9 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 1 generation backK962236 Scarf Thread-Head ScrewLandos, Inc. · 1996
- This deviceK070617 Cannulated ScrewFournitures Hospitalieres Industrie · 2007
- Descendant · cites it directly · 0 of its ownK170040 BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie · 2017
- Descendant · cites it directly · 0 of its ownK151241 Synchro-Medical TIGER TRACK Screw SystemSynchro Medical · 2015
- Descendant · cites it directly · 0 of its ownK150471 CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie · 2015
- Descendant · cites it directly · 0 of its ownK150463 CalcaNail Orthopedic NailFournitures Hospitalieres Industrie · 2015
Most influential descendants
Showing 4 of 4 · See all- K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie · 2017 · cites it directly0descendants
- K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical · 2015 · cites it directly0descendants
- K150471CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie · 2015 · cites it directly0descendants
- K150463CalcaNail Orthopedic NailFournitures Hospitalieres Industrie · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −1 | K962236 | Scarf Thread-Head Screw | Landos, Inc. | 1996 | — |
| 0 (this device) | K070617 | Cannulated Screw | Fournitures Hospitalieres Industrie | 2007 | — |
| +1 | K170040 | BePOD Cannulated Arthrodesis Screws | Fournitures Hospitalieres Industrie | 2017 | — |
| +1 | K151241 | Synchro-Medical TIGER TRACK Screw System | Synchro Medical | 2015 | — |
| +1 | K150471 | CalcaNail Orthopedic Arthrodesis Nail | Fournitures Hospitalieres Industrie | 2015 | — |
| +1 | K150463 | CalcaNail Orthopedic Nail | Fournitures Hospitalieres Industrie | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 3 | 0 |
| 2017 | 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? (5)
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 |
|---|---|---|---|
| * | K041456 | Snap-Off ScrewsSummary page 1…ATE DEVICES: Manufacturer: Fournitures Hlospitaticres Industrie Device Trade Name: Snap-off screws 5 10(K): K041456 Date claered : August 2 5rh 2004 Manufacturer: NewDeal SA Device' Trade Name… | 2004 |
| * | K990622 | Bold ScrewSummary page 1…aered : August 2 5rh 2004 Manufacturer: NewDeal SA Device' Trade Name: BOLD®~ screw 5 10 (K): K990622 and K0ll1262 Date claered : June 1 5Ih 2001 and April 29"' 1999 Manufacturer: MEDINO V-… | 1999 |
| * | K011262 | Modification to the Bold Screw | 2001 |
| * | K971070 | Scarf Thread-Head (TM) Head ScrewSummary page 1…001 and April 29"' 1999 Manufacturer: MEDINO V-AMP Device Trade Name: Scarf'Thread-Head screw 5 10 (K): K971070 and K(962236 Date claered : July 9"' 1997 and September 20"' 1996… | 1997 |
| * | K962236 | Scarf Thread-Head ScrewSummary page 2…Industrie - BOLD Cannulated Compression screw (K990622 and KOI 1262), manufactured by Newdeal, - Scarf Thread-Head screw (K971070 and K962236) manufactured by Medinov-AMP. COMPARISON OF TECHNOLOGICAL C!!ARACTERISTICS: The cannulated screws have the s… | 1996 |
What descends from it? (4)
4 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 28 years and passes through 3 companies; a new generation was cleared every 16.9 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K170040 (Fournitures Hospitalieres Industrie, 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K041456.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 screws are used to fix bone fragments of the foot together for osteosynthesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070617: Cannulated Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070617
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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