510(k) · Cleared
ClearedN-Force Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovision, Inc. · HWC Screw, Fixation, Bone
Cleared on Jul 28, 2011 as substantially equivalent to K083912 (Treu-Instrumente GmbH, 2009) and 4 other predicates after a 328-day review. Its family tree reaches back 10 generations to 1996. 5 later devices descend from it.
- Decided
- Jul 28, 2011
- Review
- 328 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K960978 (1996). 77 ancestors in all, the oldest K792022 (1979). 5 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 6 generations between
- 3 generations backK090855 Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009
- 2 generations backK093447 CarrigenEtex Corp. · 2010
- 1 generation backK101557 Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp. · 2010
- This deviceK102528 N-Force Fixation SystemInnovision, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK132244 N-Force Fixation SystemInnovision, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK151146 N-Force Fixation SystemInnovision, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK142776 Flow-ScrewFlow-Fx, LLC · 2015
- Descendant · 2 generations on · 0 of its ownK173556 Injection ScrewBiedermann Medtech, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK160791 AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc. · 2016
Show all 10 generations
- Root · 10 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 9 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 8 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 7 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 6 generations backK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
- 5 generations backK081439 Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008
- 4 generations backK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008
- 3 generations backK090855 Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009
- 2 generations backK093447 CarrigenEtex Corp. · 2010
- 1 generation backK101557 Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp. · 2010
- This deviceK102528 N-Force Fixation SystemInnovision, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K132244N-Force Fixation SystemInnovision, Inc. · 2014 · cites it directly3descendants
- K151146N-Force Fixation SystemInnovision, Inc. · 2015 · cites it directly1descendant
- K142776Flow-ScrewFlow-Fx, LLC · 2015 · cites it directly1descendant
- K173556Injection ScrewBiedermann Medtech, Inc. · 2018 · 2 generations on0descendants
- K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −9 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −8 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −7 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −6 | K072184 | Vitoss Bioactive Foam Bone Graft Substitute | Orthovita, Inc. | 2007 | — |
| −5 | K081439 | Vitoss Bioactive Foam Pack Bone Graft Substitute | Orthovita, Inc. | 2008 | — |
| −4 | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam &… | Orthovita, Inc. | 2008 | — |
| −3 | K090855 | Equivabone Osteoinductive Bone Graft Substitute | Etex Corp. | 2009 | — |
| −2 | K093447 | Carrigen | Etex Corp. | 2010 | — |
| −1 | K101557 | Gamma-BSM, Beta-BSM, Equivabone, Carigen | Etex Corp. | 2010 | — |
| 0 (this device) | K102528 | N-Force Fixation System | Innovision, Inc. | 2011 | — |
| +1 | K132244 | N-Force Fixation System | Innovision, Inc. | 2014 | — |
| +1 | K151146 | N-Force Fixation System | Innovision, Inc. | 2015 | — |
| +1 | K142776 | Flow-Screw | Flow-Fx, LLC | 2015 | — |
| +2 | K173556 | Injection Screw | Biedermann Medtech, Inc. | 2018 | — |
| +1 | K160791 | AmorChem Titanium Porous Fixation Device | Amorchem Holdings, Inc. | 2016 | — |
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 | 6 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsSummary page 1…Predicate Devices: The N-Force Fixation System was shown to be substantially equivalent to previously cleared screw devices including Treu Bone Fixation Screws and Pins (K083912) and S&N 4.0mmn Cannulated Screws (K993 106); the Haig Nail System (K961213 and K991889) which, like the… | 2009 |
| * | K993106 | Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)Summary page 1…tem was shown to be substantially equivalent to previously cleared screw devices including Treu Bone Fixation Screws and Pins (K083912) and S&N 4.0mmn Cannulated Screws (K993 106); the Haig Nail System (K961213 and K991889) which, like the… | 1999 |
| * | K961213 | Alta Dome and Plunger (Mec Hip Bolt)Summary page 1…equivalent to previously cleared screw devices including Treu Bone Fixation Screws and Pins (K083912) and S&N 4.0mmn Cannulated Screws (K993 106); the Haig Nail System (K961213 and K991889) which, like the K102528… | 1996 |
| * | K991889 | Ultimax Haig II Nail SystemSummary page 1…to previously cleared screw devices including Treu Bone Fixation Screws and Pins (K083912) and S&N 4.0mmn Cannulated Screws (K993 106); the Haig Nail System (K961213 and K991889) which, like the K102528 - Page 2 of… | 1999 |
| * | K101557 | Gamma-BSM, Beta-BSM, Equivabone, CarigenSummary page 2…ew, is a fracture fixation device that temporarily serves as a surgical instrument; and the delivery systems used with ETEX Beta-bsm and ETEX CarriGen bone void fillers (K101 557). Substantial Equivalence: Testing performed on the N-Force Screw indicates that it is substantially equivalent to predicate de… | 2010 |
What descends from it? (5)
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 15 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 7 of the 77 ancestors have a recall of any class.
- Of its descendants, K132244 (Innovision, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 10 other devices also cite its predicate K083912.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 N-Force Fixation System is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the N-Force Fixation System can also be used to deliver the following bone void fillers to a surgical site:
Beta-bsm (ETEX Corporation)
CarriGen (ETEX Corporation)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102528: N-Force Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102528
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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