510(k) · Cleared
ClearedLITe BIO Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · FMF Syringe, Piston
Cleared on Jul 8, 2016 as substantially equivalent to K121124 (Arthrex, Inc., 2012) and 2 other predicates after a 92-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Jul 8, 2016
- Review
- 92 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K960978 (1996). 50 ancestors in all, the oldest K852682 (1985). No later device cites it as a predicate yet.
- Root · 9 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 5 generations between
- 3 generations backK101860 Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010
- 2 generations backK110368 Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- 1 generation backK112773 Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- This deviceK160978 LITe BIO Delivery SystemStryker Corporation · 2016
Show all 9 generations
- Root · 9 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 8 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 7 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 6 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 5 generations backK080009 Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC · 2008
- 4 generations backK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
- 3 generations backK101860 Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010
- 2 generations backK110368 Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- 1 generation backK112773 Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC · 2011
- This deviceK160978 LITe BIO Delivery SystemStryker Corporation · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −8 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −7 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −6 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −5 | K080009 | Novabone Putty- Bioactive Synthetic Graft | Novabone Products, LLC | 2008 | — |
| −4 | K082672 | Novabone Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2008 | — |
| −3 | K101860 | Novabone Putty- Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2010 | — |
| −2 | K110368 | Novabone Putty - Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2011 | — |
| −1 | K112773 | Novabne Putty Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2011 | — |
| 0 (this device) | K160978 | LITe BIO Delivery System | Stryker Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K121124 | Arthrex Mixing and Delivery SystemSummary page 4…21 CFR § 880.5860 Codification Product Codes FMF Predicate Devices Primary Predicate: • Arthrex Mixing and Delivery System - K121124 Additional Predicates: • Biomet Graft Delivery Syringes - K140710… | 2012 |
| * | K140710 | Biomet Graft Delivery SyringesSummary page 4…• Arthrex Mixing and Delivery System - K121124 Additional Predicates: • Biomet Graft Delivery Syringes - K140710 • NovaBone MIS Cartridge Delivery System - K112773 Reference Devices:… | 2014 |
| * | K112773 | Novabne Putty Bioactive Synthetic Bone GraftSummary page 4…Additional Predicates: • Biomet Graft Delivery Syringes - K140710 • NovaBone MIS Cartridge Delivery System - K112773 Reference Devices: • Imbibe Bone Marrow Aspiration Syringe – K023074… | 2011 |
| † | K023074 | Imbibe Bone Marrow Aspiration Syringe | 2003 |
| † | K133328 | Aero-AL Lumbar Cage System | 2014 |
| † | K152532 | AERO -C Cervical Cage 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 20 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 50 ancestors have a recall of any class.
- 4 other devices also cite its predicate K121124.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The LITe® BIO Delivery System is intended to deliver autograft, allograft, or synthetic bone grafting materials to all orthopedic surgical sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160978 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160978: LITe BIO Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160978
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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