510(k) · Cleared
ClearedControlled Delivery for Osteoplasty (Cdo System) and Graft Preparation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · FMF Syringe, Piston
Cleared on Dec 6, 2007 as substantially equivalent to K030208 (Orthovita, Inc., 2003) and 2 other predicates after a 108-day review. Its family tree reaches back 2 generations to 2001. 47 later devices descend from it.
- Decided
- Dec 6, 2007
- Review
- 108 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K003286 (2001). 7 ancestors in all. 47 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK003286 Symphony Graft Delivery SystemDepuyacromed · 2001
- 1 generation backK021071 PCCS Graft Delivery SystemBiomet, Inc. · 2002 · Recalled
- This deviceK072330 Controlled Delivery for Osteoplasty (Cdo System) and Graft…Biomet, Inc. · 2007
- Descendant · cites it directly · 45 of its ownK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
- Descendant · 2 generations on · 41 of its ownK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
- Descendant · 3 generations on · 40 of its ownK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
- Descendant · 3 generations on · 32 of its ownK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
- Descendant · 4 generations on · 31 of its ownK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K100754Graft Delivery System Model SA-6115Micromedics, Inc. · 2010 · cites it directly45descendants
- K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011 · 2 generations on41descendants
- K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012 · 3 generations on40descendants
- K133021Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014 · 3 generations on32descendants
- K141245Etex Mixing and Delivery SystemEtex Corporation · 2014 · 4 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003286 | Symphony Graft Delivery System | Depuyacromed | 2001 | — |
| −1 | K021071 | PCCS Graft Delivery System | Biomet, Inc. | 2002 | 1 |
| 0 (this device) | K072330 | Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation System | Biomet, Inc. | 2007 | — |
| +1 | K100754 | Graft Delivery System Model SA-6115 | Micromedics, Inc. | 2010 | — |
| +2 | K111632 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2011 | — |
| +3 | K121476 | Infill Graft Delivery System | Pinnacle Spine Group, LLC | 2012 | — |
| +3 | K133021 | Mixing Syringe System | Zimmer Knee Creations, Inc. | 2014 | — |
| +4 | K141245 | Etex Mixing and Delivery System | Etex Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 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 16.2 · 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 |
|---|---|---|---|
| * | K030208 | Imbibe II SyringeSummary page 1…mon Name: Piston Syringe Classification Name: FMF (21 CRIF 880.5860) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: CDO' m System K030208 IMBIBE II Syringe (Orthovia, Inc., Malvern, PA) K022246 Symphony Graft Delivery System (DePuy AcroMed, Raynham, MA)… | 2003 |
| * | K022246 | Modification to Symphony Graft Delivery SystemSummary page 1…FMF (21 CRIF 880.5860) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: CDO' m System K030208 IMBIBE II Syringe (Orthovia, Inc., Malvern, PA) K022246 Symphony Graft Delivery System (DePuy AcroMed, Raynham, MA) Graft Preparation System K021071 Graft Delivery Syste… | 2002 |
| * | K021071 | PCCS Graft Delivery SystemSummary page 1…System K030208 IMBIBE II Syringe (Orthovia, Inc., Malvern, PA) K022246 Symphony Graft Delivery System (DePuy AcroMed, Raynham, MA) Graft Preparation System K021071 Graft Delivery System (Biomet Biologics, Inc., Warsaw, IN) Device Description: CDO TM System The CDO TM System consists… | 2002 |
What descends from it? (47)
See all 474 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 6 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K100754 (Micromedics, Inc., 2010) has gone furthest, with 45 descendants of its own.
- 6 other devices also cite its predicate K030208.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
CDO TM System The CDO TM System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft material with I.V. fluids, blood, plasma concentrate, platelet-rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements. Graft Preparation System The Graft…
Read the full statement (126 words)
CDO TM System
The CDO TM System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft material with I.V. fluids, blood, plasma concentrate, platelet-rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.
Graft Preparation System
The Graft Preparation System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft material with I.V. fluids, blood, plasma concentrate, platelet-rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072330 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072330: Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072330
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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