510(k) · Cleared
ClearedInfill Graft Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pinnacle Spine Group, LLC · FMF Syringe, Piston
Cleared on Aug 11, 2011 as substantially equivalent to K023088 (Wrightmedicaltechnologyinc, 2002) and 1 other predicate after a 59-day review. Its family tree reaches back 5 generations to 2002. 41 later devices descend from it.
- Decided
- Aug 11, 2011
- Review
- 59 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K013966 (2002). 16 ancestors in all, the oldest K994337 (2000). 41 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 4 generations backK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
- 3 generations backK031817 Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc · 2003
- 2 generations backK043261 Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · Recalled
- 1 generation backK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
- This deviceK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
- Descendant · cites it directly · 40 of its ownK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
- Descendant · cites it directly · 32 of its ownK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
- Descendant · 2 generations on · 31 of its ownK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
- Descendant · 3 generations on · 21 of its ownK161568 Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016
- Descendant · 2 generations on · 15 of its ownK142661 Bi-Portal Bone Graft Delivery DeviceSpinal Surgical Strategies, LLC · 2014
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012 · cites it directly40descendants
- K133021Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014 · cites it directly32descendants
- K141245Etex Mixing and Delivery SystemEtex Corporation · 2014 · 2 generations on31descendants
- K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016 · 3 generations on21descendants
- K142661Bi-Portal Bone Graft Delivery DeviceSpinal Surgical Strategies, LLC · 2014 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K013966 | Apatight-TCP Bone Graft Substitute | Cerabio, LLC | 2002 | — |
| −4 | K022629 | WMT-TCP Bone Graft Substitute | Wrightmedicaltechnologyinc | 2002 | — |
| −3 | K031817 | Cellplex TCP Synthetic Cancellous Bone | Wrightmedicaltechnologyinc | 2003 | — |
| −2 | K043261 | Harvest Graft Delivery Syringe | Harvest Technologies, Corp. | 2005 | 2 |
| −1 | K100754 | Graft Delivery System Model SA-6115 | Micromedics, Inc. | 2010 | — |
| 0 (this device) | K111632 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2011 | — |
| +1 | K121476 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2012 | — |
| +1 | K133021 | Mixing Syringe System | Zimmer Knee Creations, Inc. | 2014 | — |
| +2 | K141245 | Etex Mixing and Delivery System | Etex Corporation | 2014 | — |
| +3 | K161568 | Bone Solutions Mixing and Delivery System | Bone Solutions, Inc. | 2016 | — |
| +2 | K142661 | Bi-Portal Bone Graft Delivery Device | Spinal Surgical Strategies, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K023088 | Bone Graft Syringe, Model 8600-00X0Summary page 1…11 CLASSIFICATION: REGULATION 880.5860 NUMBER PRODUCT CODE FMF PREDICATE DEVICES: Wright Medical Bone Graft Syringe, K023088 FibirJet Graft Delivery System Ki 00754 Substantially Equivalent To: The InFillTm Graft Delivery… | 2002 |
| * | K100754 | Graft Delivery System Model SA-6115 | 2010 |
What descends from it? (41)
See all 413 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 9 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K121476 (Pinnacle Spine Group, LLC, 2012) has gone furthest, with 40 descendants of its own.
- 4 other devices also cite its predicate K023088.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 InFillTM Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111632 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111632: Infill Graft Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111632
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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