510(k) Report

510(k) · Cleared

Cleared

Mixing Syringe System

K133021510(k) TraditionalCleared Jan 13, 2014109-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

Zimmer Knee Creations, Inc. · FMF Syringe, Piston

Cleared on Jan 13, 2014 as substantially equivalent to K121124 (Arthrex, Inc., 2012) and 2 other predicates after a 109-day review. Its family tree reaches back 7 generations to 2002. 32 later devices descend from it.

Decided
Jan 13, 2014
Review
109 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
3

Its longest line of descent runs back 7 generations to K013966 (2002). 24 ancestors in all, the oldest K994337 (2000). 32 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2006: 2 other ancestors2002: 3 other ancestors2001: 6 other ancestors2007: 1 other ancestor2004: 1 other ancestor2003: 2 other ancestors2000: 1 other ancestor2014: 1 descendant cleared2016: 2 descendants cleared2019: 2 descendants cleared2017: 2 descendants cleared2023: 4 descendants cleared2020: 7 descendants cleared2018: 3 descendants cleared2021: 2 descendants cleared2022: 2 descendants cleared2025: 2 descendants cleared2026: 1 descendant cleared2024: 4 descendants 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: 1 other ancestor2 generations back: 4 other ancestors3 generations back: 8 other ancestors4 generations back: 1 other ancestor5 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 6 descendants4 generations forward: 15 descendants5 generations forward: 5 descendants6 generations forward: 1 descendant7 generations 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+5
  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 deviceK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014
  9. Descendant · cites it directly · 31 of its ownK141245 Etex Mixing and Delivery SystemEtex Corporation · 2014
  10. Descendant · 2 generations on · 21 of its ownK161568 Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016
  11. Descendant · 3 generations on · 11 of its ownK170675 Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2017
  12. Descendant · 2 generations on · 10 of its ownK161447 HydroSet XTOrthovita, Inc. · 2016 · Recalled
  13. Descendant · 3 generations on · 7 of its ownK181255 PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2014: 12016: 22017: 22018: 32019: 22020: 72021: 22022: 22023: 42024: 42025: 22026: 1
2014high 7 (2020) · low 0 (2015)2026

Most influential descendants

Showing 5 of 32 · See all
  • K141245Etex Mixing and Delivery SystemEtex Corporation · 2014 · cites it directly31descendants
  • K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. · 2016 · 2 generations on21descendants
  • K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2017 · 3 generations on11descendants
  • K161447HydroSet XTOrthovita, Inc. · 2016 · 2 generations on10descendants
  • K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc · 2018 · 3 generations on7descendants
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)K133021Mixing Syringe SystemZimmer Knee Creations, Inc.2014—
+1K141245Etex Mixing and Delivery SystemEtex Corporation2014—
+2K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc.2016—
+3K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC2017—
+2K161447HydroSet XTOrthovita, Inc.20162
+3K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc2018—

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
201410
201620
201720
201830
201920
202070
202120
202220
202340
202440
202520
202610
FIG. 1 — Lineage of K133021, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K121124Arthrex Mixing and Delivery System
Summary page 1
…vice: The Mixing Syringe System has the same indications for use, design, function, materials, and is substantially equivalent to the Arthrex Mixing and Delivery System (K121 124) and InFill graft Delivery System (K121476, KI 11632).…
Arthrex, Inc.2012—
*K121476Infill Graft Delivery System
Summary page 1
…indications for use, design, function, materials, and is substantially equivalent to the Arthrex Mixing and Delivery System (K121 124) and InFill graft Delivery System (K121476, KI 11632). K(133021…
Pinnacle Spine Group, LLC2012—
*K111632Infill Graft Delivery System
Summary page 2
…ce. Therefore, the Mixing Syringe System is substantially equivalent to the Arthrex Mixing and Delivery System (K 121 124) and InFill graft Delivery System (K 121476, KI 111632). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Heaitih Service…
Pinnacle Spine Group, LLC2011—

Also cleared against K121124: 4 other devices →

What descends from it? (32)

See all 32

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

NumberDeviceApplicantDecidedDescendants
K141245Etex Mixing and Delivery SystemEtex Corporation201431

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, K141245 (Etex Corporation, 2014) has gone furthest, with 31 descendants of its own.
  • 4 other devices also cite its predicate K121124.

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 Mixing Syringe 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.

Also cleared against K121124

4 other devices cite the same predicate.

  • K160978LITe BIO Delivery SystemStryker Corporation · 2016
  • K142535ConMed Mixing and Delivery KitConmed Corporation · 2015
  • K140710Biomet Graft Delivery SyringesBiomet Spine (Aka Ebi, LLC) · 2014
  • K141245Etex Mixing and Delivery SystemEtex Corporation · 2014

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/K133021 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133021: Mixing Syringe System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133021

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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