510(k) · Cleared
ClearedIfs Cannulated Bone Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Internal Fixation Systems, Inc. · HWC Screw, Fixation, Bone
Cleared on Jul 26, 2006 as substantially equivalent to K050754 (Precimed, Inc., 2005) and 5 other predicates after a 47-day review. Its family tree reaches back 2 generations to 1999. 5 later devices descend from it.
- Decided
- Jul 26, 2006
- Review
- 47 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K991151 (1999). 7 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK991151 Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex…Vilex, Inc. · 1999
- 1 generation backK042310 Ortho-Pro Cannulated Bone ScrewsOrtho-Pro, LLC · 2004
- This deviceK061620 Ifs Cannulated Bone ScrewInternal Fixation Systems, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK063589 Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC · 2007
- Descendant · 2 generations on · 3 of its ownK071035 Ifs Bone Fixation DevicesInternal Fixation Systems, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK130613 Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga · 2014
- Descendant · 2 generations on · 0 of its ownK252758 Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK140216 Orthopedic Fixation SystemsImpact Medical, LLC · 2014
Most influential descendants
Showing 5 of 5 · See all- K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC · 2007 · cites it directly4descendants
- K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc. · 2007 · 2 generations on3descendants
- K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga · 2014 · cites it directly1descendant
- K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc. · 2025 · 2 generations on0descendants
- K140216Orthopedic Fixation SystemsImpact Medical, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991151 | Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated… | Vilex, Inc. | 1999 | — |
| −1 | K042310 | Ortho-Pro Cannulated Bone Screws | Ortho-Pro, LLC | 2004 | — |
| 0 (this device) | K061620 | Ifs Cannulated Bone Screw | Internal Fixation Systems, Inc. | 2006 | — |
| +1 | K063589 | Gso Bone Fixation Fasteners | Gold Standard Orthopaedics, LLC | 2007 | — |
| +2 | K071035 | Ifs Bone Fixation Devices | Internal Fixation Systems, Inc. | 2007 | — |
| +1 | K130613 | Cannulated Screw and Kirschner (Kwire) System | Laura Cattabriga | 2014 | — |
| +2 | K252758 | Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. | 2025 | — |
| +1 | K140216 | Orthopedic Fixation Systems | Impact Medical, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2005 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2014 | 2 | 0 |
| 2025 | 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? (6)
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 |
|---|---|---|---|
| * | K050754 | Precimed Cannulated Screw SystemSummary page 1…Manufacturer Trade Name 510(k) Number Equivalent Devices: Precimed, Inc. Precimed Cannulated K050754 Screw System Nexa Orthopedics Nexa Bone S… | 2005 |
| * | K053394 | Nexa Bone Screw SystemSummary page 1…K050754 Screw System Nexa Orthopedics Nexa Bone Screw System K053394 aap Implants, Inc. aap Cannulated Screw K990776… | 2005 |
| * | K990776 | Aap Cannulated Screw, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MMSummary page 1…Nexa Orthopedics Nexa Bone Screw System K053394 aap Implants, Inc. aap Cannulated Screw K990776 Ortho-Pro LLC Cannulated Bone Screws K042310… | 1999 |
| * | K042310 | Ortho-Pro Cannulated Bone ScrewsSummary page 1…aap Implants, Inc. aap Cannulated Screw K990776 Ortho-Pro LLC Cannulated Bone Screws K042310 Vilex, Inc. Vilex Cannulated Screws K991151… | 2004 |
| * | K991151 | Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated Bone ScrewSummary page 1…Ortho-Pro LLC Cannulated Bone Screws K042310 Vilex, Inc. Vilex Cannulated Screws K991151 K991197 Device Description:… | 1999 |
| * | K991197 | Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX…Summary page 1…Vilex, Inc. Vilex Cannulated Screws K991151 K991197 Device Description: The IFS Cannulated Screw is a self-tapping, self-drilling screw INTERNAL F/AXrTIO… | 1999 |
What descends from it? (5)
3 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 7 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K063589 (Gold Standard Orthopaedics, LLC, 2007) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K050754.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Intended Use of the IFS Cannulated Bone Screw is for the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsals and phalangeal osteotomies and arthrodses of the hand and foot.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061620 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061620: Ifs Cannulated Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061620
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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