510(k) Report

510(k) · Cleared

Cleared

Graft Delivery System Model SA-6115

K100754510(k) TraditionalCleared Jun 9, 201084-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

Micromedics, Inc. · FMF Syringe, Piston

Cleared on Jun 9, 2010 as substantially equivalent to K072330 (Biomet, Inc., 2007) and 1 other predicate after an 84-day review. Its family tree reaches back 4 generations to 2002. 45 later devices descend from it.

Decided
Jun 9, 2010
Review
84 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K013966 (2002). 15 ancestors in all, the oldest K994337 (2000). 45 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2004: 1 other ancestor2003: 1 other ancestor2002: 3 other ancestors2001: 4 other ancestors2000: 1 other ancestor2011: 2 descendants cleared2015: 2 descendants cleared2012: 1 descendant cleared2014: 5 descendants cleared2016: 3 descendants cleared2019: 2 descendants cleared2024: 5 descendants cleared2017: 2 descendants cleared2023: 6 descendants cleared2020: 7 descendants cleared2018: 3 descendants cleared2021: 2 descendants cleared2022: 2 descendants cleared2025: 2 descendants cleared2026: 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 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 6 other ancestors3 generations back: 4 other ancestors 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 4 descendants4 generations forward: 7 descendants5 generations forward: 12 descendants6 generations forward: 10 descendants7 generations forward: 4 descendants8 generations forward: 1 descendant K043261 · 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 · 20020+5
  1. Root · 4 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
  2. 3 generations backK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
  3. 2 generations backK031817 Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc · 2003
  4. 1 generation backK043261 Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 2005 · Recalled
  5. This deviceK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
  6. Descendant · cites it directly · 41 of its ownK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
  7. Descendant · 2 generations on · 40 of its ownK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
  8. Descendant · 2 generations on · 32 of its ownK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
  9. Descendant · 3 generations on · 31 of its ownK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
  10. Descendant · 4 generations on · 21 of its ownK161568 Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016

Showing 5 of 45 descendants. See all descendants

Descendants cleared per year

2011: 22012: 12014: 52015: 22016: 32017: 22018: 32019: 22020: 72021: 22022: 22023: 62024: 52025: 22026: 1
2011high 7 (2020) · low 0 (2013)2026

Most influential descendants

Showing 5 of 45 · See all
  • K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011 · cites it directly41descendants
  • K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012 · 2 generations on40descendants
  • K133021Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014 · 2 generations on32descendants
  • K141245Etex Mixing and Delivery SystemEtex Corporation · 2014 · 3 generations on31descendants
  • K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016 · 4 generations on21descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K013966Apatight-TCP Bone Graft SubstituteCerabio, LLC2002—
−3K022629WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc2002—
−2K031817Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc2003—
−1K043261Harvest Graft Delivery SyringeHarvest Technologies, Corp.20052
0 (this device)K100754Graft Delivery System Model SA-6115Micromedics, Inc.2010—
+1K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC2011—
+2K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC2012—
+2K133021Mixing Syringe SystemZimmer Knee Creations, Inc.2014—
+3K141245Etex Mixing and Delivery SystemEtex Corporation2014—
+4K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200140
200230
200310
200410
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201210
201450
201520
201630
201720
201830
201920
202070
202120
202220
202360
202450
202520
202610
FIG. 1 — Lineage of K100754, 2002–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K072330Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation System
Summary page 1
…Fibri Jet®g Graft Delivery System COMMON NAME: Piston Syringe PRO CODE: FMF SUBSTANTIALLY EQUIVALENT PREDICATE DEVICES: K072330 Curved Delivery Option & Graft Preparation System (Biomet Biologics, Warsaw, IN) K043261 Harvest Graft Delivery System (Har…
Biomet, Inc.2007—
*K043261Harvest Graft Delivery Syringe
Summary page 1
…CODE: FMF SUBSTANTIALLY EQUIVALENT PREDICATE DEVICES: K072330 Curved Delivery Option & Graft Preparation System (Biomet Biologics, Warsaw, IN) K043261 Harvest Graft Delivery System (Harvest Technologies Corp., Plymouth, MA) DEVICE DESCRIPTION: The Fibri Jet® Graft Delivery Sy…
Harvest Technologies, Corp.20052

Also cleared against K072330: 3 other devices →

What descends from it? (45)

See all 45

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC201141
K110787Tripore TDD (HA), Tripore TDD (BP90), Tripore TDD (BP15)Orthogem Limited20111
K151543Graft Delivery Device with Integrated StyletMicromedics, Inc. (D/B/A Nordson Medical)20150

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 8 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
  • 2 of the 15 ancestors have a recall of any class.
  • Of its descendants, K111632 (Pinnacle Spine Group, LLC, 2011) has gone furthest, with 41 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. 2010, 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?

FibriJet® Graft Delivery System is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as 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.

Also cleared against K072330

3 other devices cite the same predicate.

  • K151543Graft Delivery Device with Integrated StyletMicromedics, Inc. (D/B/A Nordson Medical) · 2015
  • K140710Biomet Graft Delivery SyringesBiomet Spine (Aka Ebi, LLC) · 2014
  • K141762Perfuse Percutaneous Decompression SystemBiomet, Inc. · 20141 recall

More from Micromedics, Inc.

29 FDA decisions under this applicant name. See the company

  • K241739Endoscopic Applicator, 41 cmMicromedics, Inc. · 2024
  • K123847Malleable Tip Endoscopic ApplicatorMicromedics, Inc. · 2013
  • K122526360 Gas Assisted Endoscopic ApplicatorMicromedics, Inc. · 2012
  • K120608Endoscopic ApplicatorMicromedics, Inc. · 2012
  • K102563Single Cannula Extended ApplicatorMicromedics, Inc. · 2011

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/K100754 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100754: Graft Delivery System Model SA-6115.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100754

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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