510(k) · Cleared
ClearedInjection Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biedermann Medtech, Inc. · HWC Screw, Fixation, Bone
Cleared on Jul 13, 2018 as substantially equivalent to K142776 (Flow-Fx, LLC, 2015) and 4 other predicates after a 238-day review. Its family tree reaches back 13 generations to 1996.
- Decided
- Jul 13, 2018
- Review
- 238 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 13 generations to K960978 (1996). 203 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 13 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 9 generations between
- 3 generations backK102528 N-Force Fixation SystemInnovision, Inc. · 2011
- 2 generations backK132244 N-Force Fixation SystemInnovision, Inc. · 2014
- 1 generation backK142776 Flow-ScrewFlow-Fx, LLC · 2015
- This deviceK173556 Injection ScrewBiedermann Medtech, Inc. · 2018
Show all 13 generations
- Root · 13 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 12 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 11 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 10 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 9 generations backK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
- 8 generations backK081439 Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008
- 7 generations backK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008
- 6 generations backK090855 Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009
- 5 generations backK093447 CarrigenEtex Corp. · 2010
- 4 generations backK101557 Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp. · 2010
- 3 generations backK102528 N-Force Fixation SystemInnovision, Inc. · 2011
- 2 generations backK132244 N-Force Fixation SystemInnovision, Inc. · 2014
- 1 generation backK142776 Flow-ScrewFlow-Fx, LLC · 2015
- This deviceK173556 Injection ScrewBiedermann Medtech, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −12 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −11 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −10 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −9 | K072184 | Vitoss Bioactive Foam Bone Graft Substitute | Orthovita, Inc. | 2007 | — |
| −8 | K081439 | Vitoss Bioactive Foam Pack Bone Graft Substitute | Orthovita, Inc. | 2008 | — |
| −7 | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam &… | Orthovita, Inc. | 2008 | — |
| −6 | K090855 | Equivabone Osteoinductive Bone Graft Substitute | Etex Corp. | 2009 | — |
| −5 | K093447 | Carrigen | Etex Corp. | 2010 | — |
| −4 | K101557 | Gamma-BSM, Beta-BSM, Equivabone, Carigen | Etex Corp. | 2010 | — |
| −3 | K102528 | N-Force Fixation System | Innovision, Inc. | 2011 | — |
| −2 | K132244 | N-Force Fixation System | Innovision, Inc. | 2014 | — |
| −1 | K142776 | Flow-Screw | Flow-Fx, LLC | 2015 | — |
| 0 (this device) | K173556 | Injection Screw | Biedermann Medtech, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 17 | 0 |
| 1997 | 5 | 0 |
| 1998 | 10 | 0 |
| 1999 | 8 | 0 |
| 2000 | 15 | 0 |
| 2001 | 17 | 0 |
| 2002 | 8 | 0 |
| 2003 | 15 | 0 |
| 2004 | 20 | 0 |
| 2005 | 15 | 0 |
| 2006 | 8 | 0 |
| 2007 | 8 | 0 |
| 2008 | 8 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K142776 | Flow-ScrewSummary page 4…rimary: 21 CFR section 888.3040 – Smooth or threaded metallic bone fixation fastener Predicate Device: Primary K142776 Flow-Fx Flow-Screw Secondary K151146 N-Force Fixation System… | 2015 |
| * | K151146 | N-Force Fixation SystemSummary page 4…bone fixation fastener Predicate Device: Primary K142776 Flow-Fx Flow-Screw Secondary K151146 N-Force Fixation System Miami Device Solutions Cannulated… | 2015 |
| * | K161058 | Cannulated ScrewSummary page 4…K151146 N-Force Fixation System Miami Device Solutions Cannulated Secondary K161058 Screw K132502,… | 2016 |
| * | K132502 | Variax 2 SystemSummary page 4…lutions Cannulated Secondary K161058 Screw K132502, Secondary Variax 2 System Bone Screws K1407… | 2013 |
| * | K140769 | Variax 2 SystemSummary page 4…K132502, Secondary Variax 2 System Bone Screws K140769 Reference Devices: Paragon 28, Inc.; The Monster Screw System: Instrument Reprocessing Instructions… | 2014 |
| † | K151418 | Monster Screw System | 2015 |
| † | K161292 | Distal Radius Plating System | 2016 |
| † | K162635 | Distal Radius Plating System | 2016 |
| † | K101557 | Gamma-BSM, Beta-BSM, Equivabone, Carigen | 2010 |
| † | K141493 | Proximal Humerus Plating System | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 29 of the 203 ancestors have a recall of any class.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 MDS Injection Screw is intended for the fixation of bone fractures and bone reconstructions of the humerus. The MDS Injection Screws can be used to deliver injectable bone void fillers to a surgical site and are compatible with applicable MDS plating systems.
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/K173556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173556: Injection Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173556
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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