510(k) Report

510(k) · Cleared

Cleared

Smartjet Bone Graft Liquid Applicator (Spray Tip), Model SK/S, Smartjet Bone Graft Liquid Applicator (Dual Lumen Cannula

K011032510(k) TraditionalCleared Jul 3, 200189-day reviewClass II21 CFR 872.3930

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

Harvest Technologies, Corp. · LYC Bone Grafting Material, Synthetic

Cleared on Jul 3, 2001 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 53 later devices descend from it.

Decided
Jul 3, 2001
Review
89 days
Class
Class II
Product code
LYC
Recalls
None
Predicates
0

53 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared2010: 2 descendants cleared2004: 1 descendant cleared2007: 1 descendant cleared2003: 1 descendant cleared2014: 6 descendants cleared2015: 2 descendants cleared2016: 3 descendants cleared2011: 2 descendants cleared2012: 1 descendant 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 cleared200020052010201520202025
  1. This deviceK011032 Smartjet Bone Graft Liquid Applicator (Spray Tip), Model SK/S…Harvest Technologies, Corp. · 2001
  2. Descendant · cites it directly · 49 of its ownK021071 PCCS Graft Delivery SystemBiomet, Inc. · 2002 · Recalled
  3. Descendant · 2 generations on · 47 of its ownK072330 Controlled Delivery for Osteoplasty (Cdo System) and Graft…Biomet, Inc. · 2007
  4. Descendant · 3 generations on · 45 of its ownK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
  5. Descendant · 4 generations on · 41 of its ownK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
  6. Descendant · 5 generations on · 40 of its ownK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012

Showing 5 of 53 descendants. See all descendants

Descendants cleared per year

2002: 22003: 12004: 12007: 12010: 22011: 22012: 12014: 62015: 22016: 32017: 22018: 32019: 22020: 72021: 22022: 22023: 62024: 52025: 22026: 1
2002high 7 (2020) · low 0 (2005)2026

Most influential descendants

Showing 5 of 53 · See all
  • K021071PCCS Graft Delivery SystemBiomet, Inc. · 2002 · cites it directly49descendants
  • K072330Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation SystemBiomet, Inc. · 2007 · 2 generations on47descendants
  • K100754Graft Delivery System Model SA-6115Micromedics, Inc. · 2010 · 3 generations on45descendants
  • K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011 · 4 generations on41descendants
  • K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012 · 5 generations on40descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011032Smartjet Bone Graft Liquid Applicator (Spray Tip), Model SK/S, Smartjet Bone…Harvest Technologies, Corp.2001—
+1K021071PCCS Graft Delivery SystemBiomet, Inc.20021
+2K072330Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation SystemBiomet, Inc.2007—
+3K100754Graft Delivery System Model SA-6115Micromedics, Inc.2010—
+4K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC2011—
+5K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200310
200410
200710
201020
201120
201210
201460
201520
201630
201720
201830
201920
202070
202120
202220
202360
202450
202520
202610
FIG. 1 — Lineage of K011032, 2001–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LYC? 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 LYC device

  1. #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (53)

See all 53

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

NumberDeviceApplicantDecidedDescendants
K021071PCCS Graft Delivery SystemBiomet, Inc.200249
K020252Smartjet Grafting Liquid Applicator, Models SK/S & LK/2Harvest Technologies, Corp.20022
K091722Coaxial Applicator SystemBiomet, Inc.20100

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?

  • Of its descendants, K021071 (Biomet, Inc., 2002) has gone furthest, with 49 descendants of its own.

How does its category compare?

All LYC devices

LYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYC

3in 2025

2007: 132008: 82009: 142010: 132011: 92012: 52013: 22014: 12016: 22020: 32022: 22025: 32026 (partial year): 3
2007high 14 (2009) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYC

267in 2025

2007: 80 days median2008: 73 days median2009: 100 days median2010: 164 days median2011: 224 days median2012: 120 days median2020: 156 days median2025: 267 days median2026 (partial year): 266 days median
2007high 267 (2025) · low 73 (2008)2026

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

Recalls per year · LYC

1in 2018

2009: 12010: 22012: 22016: 22018: 1
2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LYC

2in 2025

2007: 232008: 252009: 252010: 282011: 212012: 102013: 122014: 92015: 142016: 1402017: 192018: 142019: 152020: 52021: 122022: 62023: 92024: 62025: 2
2007high 140 (2016) · low 2 (2025)2025

MAUDE reports naming product code LYC, 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
20071380023
2008873025
200914100125
201013164228
20119224021
20125120210
20132—012
20141—09
20150—014
20162—2140
20170—019
20180—114
20190—015
2020315605
20210—012
20222—06
20230—09
20240—06
2025326702
202632660—

More from Harvest Technologies, Corp.

6 FDA decisions under this applicant name. See the company

  • K121005Adiprep Adipose Transfer SystemHarvest Technologies, Corp. · 20121 recall
  • K103340SMARTPREP2 Bmac System, Smartprep Platelet Concentration SystemHarvest Technologies, Corp. · 20102 recalls
  • K052925SMARTPREP2 Centrifuge SystemHarvest Technologies, Corp. · 20062 recalls
  • K043261Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 20052 recalls
  • K020252Smartjet Grafting Liquid Applicator, Models SK/S & LK/2Harvest Technologies, Corp. · 2002

Recent decisions in LYC

The LYC category page

  • K253317Cytrans™ ElashieldGC America, Inc. · 2026
  • K253883Bonalive MaxillofacialBonalive, Ltd. · 2026
  • K251818Bontree PlusHudens Bio Co., Ltd. · 2026
  • K244006FG Bone Graft MFull Golden Biotech Co., Ltd. · 2025
  • K243745FG Bone Graft BFull Golden Biotech Corporation · 2025

https://510kreport.com/device/K011032 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011032: Smartjet Bone Graft Liquid Applicator (Spray Tip), Model SK/S, Smartjet Bone Graft Liquid Applicator (Dual Lumen Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011032

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026