510(k) Report

510(k) · Cleared

Cleared

Bi-Portal Bone Graft Delivery Device

K142661510(k) TraditionalCleared Dec 11, 201484-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

Spinal Surgical Strategies, LLC · FMF Syringe, Piston

Cleared on Dec 11, 2014 as substantially equivalent to K121476 (Pinnacle Spine Group, LLC, 2012) after an 84-day review. Its family tree reaches back 7 generations to 2002. 15 later devices descend from it.

Decided
Dec 11, 2014
Review
84 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
1

Its longest line of descent runs back 7 generations to K013966 (2002). 18 ancestors in all, the oldest K994337 (2000). 15 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 3 other ancestors2007: 1 other ancestor2004: 1 other ancestor2003: 1 other ancestor2001: 4 other ancestors2000: 1 other ancestor2024: 2 descendants cleared2017: 1 descendant cleared2023: 2 descendants cleared2021: 1 descendant cleared2020: 4 descendants cleared2022: 1 descendant cleared2025: 2 descendants cleared2018: 1 descendant 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 · 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 3 generations back: 1 other ancestor4 generations back: 1 other ancestor5 generations back: 5 other ancestors6 generations back: 4 other ancestors 1 generation forward: 4 descendants2 generations forward: 7 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant5 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 deviceK142661 Bi-Portal Bone Graft Delivery DeviceSpinal Surgical Strategies, LLC · 2014
  9. Descendant · cites it directly · 11 of its ownK170675 Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2017
  10. Descendant · 2 generations on · 6 of its ownK180937 Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2018
  11. Descendant · 3 generations on · 2 of its ownK201338 Allograft MIS Delivery SystemLifenet Health · 2020
  12. Descendant · 2 generations on · 1 of its ownK243580 GraftGun Universal Graft Delivery System (GDS)SurGenTec, LLC · 2025
  13. Descendant · 4 generations on · 1 of its ownK241426 GPS Advanced; 5 cc GPS Advanced CannulaProsidyan, Inc. · 2024

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2017: 12018: 12020: 42021: 12022: 12023: 22024: 22025: 22026: 1
2017high 4 (2020) · low 0 (2019)2026

Most influential descendants

Showing 5 of 15 · See all
  • K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2017 · cites it directly11descendants
  • K180937Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 2018 · 2 generations on6descendants
  • K201338Allograft MIS Delivery SystemLifenet Health · 2020 · 3 generations on2descendants
  • K243580GraftGun Universal Graft Delivery System (GDS)SurGenTec, LLC · 2025 · 2 generations on1descendant
  • K241426GPS Advanced; 5 cc GPS Advanced CannulaProsidyan, Inc. · 2024 · 4 generations on1descendant
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)K142661Bi-Portal Bone Graft Delivery DeviceSpinal Surgical Strategies, LLC2014—
+1K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC2017—
+2K180937Graftgun Universal Graft Delivery SystemSurGenTec, LLC2018—
+3K201338Allograft MIS Delivery SystemLifenet Health2020—
+2K243580GraftGun Universal Graft Delivery System (GDS)SurGenTec, LLC2025—
+4K241426GPS Advanced; 5 cc GPS Advanced CannulaProsidyan, Inc.2024—

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
201710
201810
202040
202110
202210
202320
202420
202520
202610
FIG. 1 — Lineage of K142661, 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? (1)

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
*K121476Infill Graft Delivery System
Summary page 4
…999 Driver Way Incline Village, NV 89451 Telephone: 408-702-7259 Predicate Device: K121476 - Infill™ Graft Delivery System (Pinnacle Spine Group, LLC) Indication for Use: The Bi-Portal…
Pinnacle Spine Group, LLC2012—

Also cleared against K121476: 3 other devices →

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC201711
K233368Allograft Delivery Device (OFAC-C)Bioventus, LLC20240
K231456Avitus® DragonWing Large Volume Autograft Delivery SystemAvitus Orthopaedics, Inc.20230
K230492Avitus® Precision Autograft Delivery SystemAvitus Orthopaedics, Inc.20230

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 18 ancestors have a recall of any class.
  • Of its descendants, K170675 (SurGenTec, LLC, 2017) has gone furthest, with 11 descendants of its own.
  • 3 other devices also cite its predicate K121476.

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 Bi-Portal Bone Graft Delivery Device is intended to be used for the delivery of

hydrated allograft or autograft to an orthopedic surgical site.

Indications for use as stated in the FDA summary.

Also cleared against K121476

3 other devices cite the same predicate.

  • K143488InFill Graft Delivery SystemPinnacle Spine Group, LLC · 2014
  • K140710Biomet Graft Delivery SyringesBiomet Spine (Aka Ebi, LLC) · 2014
  • K133021Mixing Syringe SystemZimmer Knee Creations, Inc. · 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/K142661 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142661: Bi-Portal Bone Graft Delivery Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142661

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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