510(k) Report

510(k) · Cleared

Cleared

Biomet Graft Delivery Syringes

K140710510(k) TraditionalCleared Sep 4, 2014167-day reviewClass II21 CFR 880.5860

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomet Spine (Aka Ebi, LLC) · FMF Syringe, Piston

Cleared on Sep 4, 2014 as substantially equivalent to K072330 (Biomet, Inc., 2007) and 4 other predicates after a 167-day review. Its family tree reaches back 7 generations to 2002. 1 later device descends from it.

Decided
Sep 4, 2014
Review
167 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
5

Its longest line of descent runs back 7 generations to K013966 (2002). 24 ancestors in all, the oldest K994337 (2000). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2007: 1 other ancestor2002: 3 other ancestors2006: 2 other ancestors2003: 2 other ancestors2001: 6 other ancestors2004: 1 other ancestor2000: 1 other ancestor2016: 1 descendant clearedK013966 · Apatight-TCP Bone Graft Substitute · Cerabio, LLC · 2002K022629 · WMT-TCP Bone Graft Substitute · Wrightmedicaltechnologyinc · 2002K031817 · Cellplex TCP Synthetic Cancellous Bone · Wrightmedicaltechnologyinc · 2003K043261 · Harvest Graft Delivery Syringe · Harvest Technologies, Corp. · 2005 · recalledK100754 · Graft Delivery System Model SA-6115 · Micromedics, Inc. · 2010K111632 · Infill Graft Delivery System · Pinnacle Spine Group, LLC · 2011K121476 · Infill Graft Delivery System · Pinnacle Spine Group, LLC · 2012200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 9 other ancestors3 generations back: 4 other ancestors5 generations back: 1 other ancestor 1 generation forward: 1 descendant K121476 · Infill Graft Delivery System · Pinnacle Spine Group, LLC · 2012K111632 · Infill Graft Delivery System · Pinnacle Spine Group, LLC · 2011K100754 · Graft Delivery System Model SA-6115 · Micromedics, Inc. · 2010K043261 · Harvest Graft Delivery Syringe · Harvest Technologies, Corp. · 2005 · recalledK031817 · Cellplex TCP Synthetic Cancellous Bone · Wrightmedicaltechnologyinc · 2003K022629 · WMT-TCP Bone Graft Substitute · Wrightmedicaltechnologyinc · 2002K013966 · Apatight-TCP Bone Graft Substitute · Cerabio, LLC · 2002−50
  1. Root · 7 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
  2. 6 generations backK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
  3. 5 generations backK031817 Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc · 2003
  4. 4 generations backK043261 Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · Recalled
  5. 3 generations backK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
  6. 2 generations backK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
  7. 1 generation backK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
  8. This deviceK140710 Biomet Graft Delivery SyringesBiomet Spine (Aka Ebi, LLC) · 2014
  9. Descendant · cites it directly · 0 of its ownK160978 LITe BIO Delivery SystemStryker Corporation · 2016

Most influential descendants

Showing 1 of 1 · See all
  • K160978LITe BIO Delivery SystemStryker Corporation · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K013966Apatight-TCP Bone Graft SubstituteCerabio, LLC2002—
−6K022629WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc2002—
−5K031817Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc2003—
−4K043261Harvest Graft Delivery SyringeHarvest Technologies, Corp.20052
−3K100754Graft Delivery System Model SA-6115Micromedics, Inc.2010—
−2K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC2011—
−1K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC2012—
0 (this device)K140710Biomet Graft Delivery SyringesBiomet Spine (Aka Ebi, LLC)2014—
+1K160978LITe BIO Delivery SystemStryker Corporation2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200160
200230
200320
200410
200620
200710
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
FIG. 1 — Lineage of K140710, 2002–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K072330Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation System
Summary page 4
…rials to all orthopedic surgical sites. Substantial Equivalence: The Biomet Graft Delivery System is substantially equivalent to the CDO™ and Graft Preparation Systems (K072330), the Arthrex Mixing and Delivery System (K121124), the InFill™ Graft Delivery System (K121476 & K111632) and Biomet’s Graft Deli…
Biomet, Inc.2007—
*K121124Arthrex Mixing and Delivery System
Summary page 4
…al Equivalence: The Biomet Graft Delivery System is substantially equivalent to the CDO™ and Graft Preparation Systems (K072330), the Arthrex Mixing and Delivery System (K121124), the InFill™ Graft Delivery System (K121476 & K111632) and Biomet’s Graft Delivery System (K021071). The technological character…
Arthrex, Inc.2012—
*K121476Infill Graft Delivery System
Summary page 4
…tem is substantially equivalent to the CDO™ and Graft Preparation Systems (K072330), the Arthrex Mixing and Delivery System (K121124), the InFill™ Graft Delivery System (K121476 & K111632) and Biomet’s Graft Delivery System (K021071). The technological characteristics of the subject Biomet Graft Delivery S…
Pinnacle Spine Group, LLC2012—
*K111632Infill Graft Delivery System
Summary page 4
…stantially equivalent to the CDO™ and Graft Preparation Systems (K072330), the Arthrex Mixing and Delivery System (K121124), the InFill™ Graft Delivery System (K121476 & K111632) and Biomet’s Graft Delivery System (K021071). The technological characteristics of the subject Biomet Graft Delivery System is t…
Pinnacle Spine Group, LLC2011—
*K021071PCCS Graft Delivery System
Summary page 4
…reparation Systems (K072330), the Arthrex Mixing and Delivery System (K121124), the InFill™ Graft Delivery System (K121476 & K111632) and Biomet’s Graft Delivery System (K021071). The technological characteristics of the subject Biomet Graft Delivery System is the same as, or similar to, the predicate devi…
Biomet, Inc.20021

Also cleared against K072330: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K160978LITe BIO Delivery SystemStryker Corporation20160

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 12 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
  • 2 of the 24 ancestors have a recall of any class.
  • Of its descendants, K160978 (Stryker Corporation, 2016) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K072330.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · FMF

13in 2025

2007: 232008: 92009: 142010: 112011: 162012: 92013: 122014: 132015: 112016: 122017: 132018: 82019: 112020: 152021: 202022: 242023: 222024: 142025: 132026 (partial year): 9
2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007: 90 days median2008: 74 days median2009: 94 days median2010: 130 days median2011: 109 days median2012: 86 days median2013: 154 days median2014: 84 days median2015: 87 days median2016: 146 days median2017: 135 days median2018: 87 days median2019: 146 days median2020: 107 days median2021: 175 days median2022: 211 days median2023: 173 days median2024: 130 days median2025: 114 days median2026 (partial year): 239 days median
2007high 239 (2026) · low 74 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMF

19in 2023

2007: 62008: 112009: 152010: 122011: 32012: 62013: 12014: 12015: 22017: 32018: 22019: 12020: 22021: 12022: 22023: 19, 18 Class I2026 (partial year): 2, 1 Class I
2007high 19 (2023) · low 0 (2016)2026

Class I (19 since 2007) Class II/III not classified

Adverse event reports per year · FMF

4,181in 2025

2007: 6742008: 6912009: 9132010: 6792011: 1862012: 3072013: 3262014: 2442015: 2732016: 6842017: 1,8582018: 3,9522019: 5,8632020: 5,3342021: 5,8742022: 5,2332023: 5,2142024: 5,1222025: 4,181
2007high 5,874 (2021) · low 186 (2011)2025

MAUDE reports naming product code FMF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200723906674
200897411691
2009149415913
20101113012679
2011161093186
20129866307
2013121541326
201413841244
201511872273
2016121460684
20171313531,858
201888723,952
20191114615,863
20201510725,334
20212017515,874
20222421125,233
20232217319 (18)5,214
20241413005,122
20251311404,181
202692392 (1)—

What is it indicated for?

The Biomet Graft Delivery Syringes are intended to deliver autograft, allograft or synthetic bone grafting materials to all orthopedic surgical sites.

Indications for use as stated in the FDA summary.

Also cleared against K072330

3 other devices cite the same predicate.

  • K151543Graft Delivery Device with Integrated StyletMicromedics, Inc. (D/B/A Nordson Medical) · 2015
  • K141762Perfuse Percutaneous Decompression SystemBiomet, Inc. · 20141 recall
  • K100754Graft Delivery System Model SA-6115Micromedics, Inc. · 2010

More from Biomet Spine (Aka Ebi, LLC)

13 FDA decisions under this applicant name. See the company

  • K133518Maxan Anterior Cervical Plate SystemBiomet Spine (Aka Ebi, LLC) · 20141 recall
  • K132373Biomet Access SystemBiomet Spine (Aka Ebi, LLC) · 2014
  • K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 20141 recall
  • K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
  • K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC) · 20132 recalls

Recent decisions in FMF

The FMF category page

  • K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC · 2026
  • K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc. · 2026
  • K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd. · 2026
  • K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC · 2026
  • K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc. · 2026

https://510kreport.com/device/K140710 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140710: Biomet Graft Delivery Syringes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140710

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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