510(k) · Cleared
ClearedCannulated Screw and Kirschner (Kwire) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laura Cattabriga · HWC Screw, Fixation, Bone
Cleared on Jan 22, 2014 as substantially equivalent to K071035 (Internal Fixation Systems, Inc., 2007) and 1 other predicate after a 321-day review. Its family tree reaches back 7 generations to 1976. 1 later device descends from it.
- Decided
- Jan 22, 2014
- Review
- 321 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K761228 (1976). 41 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 6 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 5 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 4 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 3 generations backK023260 1.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp. · 2002
- 2 generations backK063589 Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC · 2007
- 1 generation backK071035 Ifs Bone Fixation DevicesInternal Fixation Systems, Inc. · 2007
- This deviceK130613 Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga · 2014
- Descendant · cites it directly · 0 of its ownK252758 Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −6 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −5 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −4 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −3 | K023260 | 1.2MM Osteomed Auto-Drive Screw System | Osteomed Corp. | 2002 | — |
| −2 | K063589 | Gso Bone Fixation Fasteners | Gold Standard Orthopaedics, LLC | 2007 | — |
| −1 | K071035 | Ifs Bone Fixation Devices | Internal Fixation Systems, Inc. | 2007 | — |
| 0 (this device) | K130613 | Cannulated Screw and Kirschner (Kwire) System | Laura Cattabriga | 2014 | — |
| +1 | K252758 | Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K071035 | Ifs Bone Fixation DevicesSummary page 2…with respect to design and material and dimensional comparison. Substantial Equivalence: * Internal Fixation Systems, Inc. Bone Fixation Devices (K071035) * Internal Fixation Systems, Inc Cannulated Bone Screw (K06 1620) DEPARTMENT OF HEALTH & HUMAN SERVIC… | 2007 |
| * | K061620 | Ifs Cannulated Bone ScrewSummary page 2…Substantial Equivalence: * Internal Fixation Systems, Inc. Bone Fixation Devices (K071035) * Internal Fixation Systems, Inc Cannulated Bone Screw (K06 1620) DEPARTMENT OF HEALTH & HUMAN SERVICESPulcHat me *0… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252758 | Cannulated Screw and Kirschner (K wire) System | 2025 | 0 |
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 38 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 41 ancestors has a recall of any class.
- Of its descendants, K252758 (Orthonovis, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K071035.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Intended Use of the Cannulated Screw and Kirschner (Kwire) System is for the treatment and fixation of bone fractures and osteoitomies of various bones including the acetabulum, pelvis, humerus, radius, ulna, femur, tibia, phalanges, carpals, metacarpals, tarsals, metatarsals and fibula
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130613: Cannulated Screw and Kirschner (Kwire) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130613
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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