510(k) · Cleared
ClearedFlow-Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flow-Fx, LLC · HWC Screw, Fixation, Bone
Cleared on Mar 23, 2015 as substantially equivalent to K962823 (Synthes (Usa), 1996) and 3 other predicates after a 178-day review. Its family tree reaches back 12 generations to 1996. 1 later device descends from it.
- Decided
- Mar 23, 2015
- Review
- 178 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K960978 (1996). 80 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 8 generations between
- 3 generations backK101557 Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp. · 2010
- 2 generations backK102528 N-Force Fixation SystemInnovision, Inc. · 2011
- 1 generation backK132244 N-Force Fixation SystemInnovision, Inc. · 2014
- This deviceK142776 Flow-ScrewFlow-Fx, LLC · 2015
- Descendant · cites it directly · 0 of its ownK173556 Injection ScrewBiedermann Medtech, Inc. · 2018
Show all 12 generations
- Root · 12 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 11 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 10 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 9 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 8 generations backK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
- 7 generations backK081439 Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008
- 6 generations backK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008
- 5 generations backK090855 Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009
- 4 generations backK093447 CarrigenEtex Corp. · 2010
- 3 generations backK101557 Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp. · 2010
- 2 generations backK102528 N-Force Fixation SystemInnovision, Inc. · 2011
- 1 generation backK132244 N-Force Fixation SystemInnovision, Inc. · 2014
- This deviceK142776 Flow-ScrewFlow-Fx, LLC · 2015
Most influential descendants
Showing 1 of 1 · See all- K173556Injection ScrewBiedermann Medtech, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −11 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −10 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −9 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −8 | K072184 | Vitoss Bioactive Foam Bone Graft Substitute | Orthovita, Inc. | 2007 | — |
| −7 | K081439 | Vitoss Bioactive Foam Pack Bone Graft Substitute | Orthovita, Inc. | 2008 | — |
| −6 | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam &… | Orthovita, Inc. | 2008 | — |
| −5 | K090855 | Equivabone Osteoinductive Bone Graft Substitute | Etex Corp. | 2009 | — |
| −4 | K093447 | Carrigen | Etex Corp. | 2010 | — |
| −3 | K101557 | Gamma-BSM, Beta-BSM, Equivabone, Carigen | Etex Corp. | 2010 | — |
| −2 | K102528 | N-Force Fixation System | Innovision, Inc. | 2011 | — |
| −1 | K132244 | N-Force Fixation System | Innovision, Inc. | 2014 | — |
| 0 (this device) | K142776 | Flow-Screw | Flow-Fx, LLC | 2015 | — |
| +1 | K173556 | Injection Screw | Biedermann Medtech, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 7 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 8 | 0 |
| 2004 | 5 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 6 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSummary page 4…6 or stainless steel conforming to ASTM F138 or ASTM F2229. Predicate Devices: The Flow-Screw was shown to be substantially equivalent to the Synthes Cannulated Screws (K962823 and K962011) and the N-Force Fixation System (K102528 and K132244). Substantial Equivalence: The table below summarizes the subs… | 1996 |
| * | K962011 | Synthes 7.0/7.3 MM Cannulated ScrewsSummary page 4…ss steel conforming to ASTM F138 or ASTM F2229. Predicate Devices: The Flow-Screw was shown to be substantially equivalent to the Synthes Cannulated Screws (K962823 and K962011) and the N-Force Fixation System (K102528 and K132244). Substantial Equivalence: The table below summarizes the substantial equi… | 1996 |
| * | K102528 | N-Force Fixation SystemSummary page 4…2229. Predicate Devices: The Flow-Screw was shown to be substantially equivalent to the Synthes Cannulated Screws (K962823 and K962011) and the N-Force Fixation System (K102528 and K132244). Substantial Equivalence: The table below summarizes the substantial equivalence of the Flow-Screw to predicate dev… | 2011 |
| * | K132244 | N-Force Fixation SystemSummary page 4…cate Devices: The Flow-Screw was shown to be substantially equivalent to the Synthes Cannulated Screws (K962823 and K962011) and the N-Force Fixation System (K102528 and K132244). Substantial Equivalence: The table below summarizes the substantial equivalence of the Flow-Screw to predicate devices with re… | 2014 |
| † | K062630 | Ossipro Bone Substitute Material | 2007 |
| † | K072355 | Ossifuse Bone Substitute Material | 2007 |
| † | K090242 | Gamma-BSM, Beta-BSM | 2009 |
| † | K101557 | Gamma-BSM, Beta-BSM, Equivabone, Carigen | 2010 |
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 |
|---|---|---|---|
| K173556 | Injection Screw | 2018 | 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 19 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 7 of the 80 ancestors have a recall of any class.
- Of its descendants, K173556 (Biedermann Medtech, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 19 other devices also cite its predicate K962823.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Flow-Screw is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the Flow-Screw can also be used to deliver injectable bone void fillers to a surgical site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142776 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142776: Flow-Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142776
Report an extraction error
Are you the manufacturer?
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