510(k) Report

510(k) · Cleared

Recalled · 2007

PCCS Graft Delivery System

K021071510(k) TraditionalCleared Jul 1, 200290-day reviewClass II21 CFR 880.5860Recalls 1

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

Biomet, Inc. · FMF Syringe, Piston

Cleared on Jul 1, 2002 as substantially equivalent to K003286 (Depuyacromed, 2001) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 2001. 49 later devices descend from it. It has been recalled once.

Decided
Jul 1, 2002
Review
90 days
Class
Class II
Product code
FMF
Recalls
1
Predicates
3

Its longest line of descent runs back 1 generation to K003286 (2001). 3 ancestors in all. 49 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2007: 1 descendant cleared2003: 1 descendant cleared2014: 6 descendants cleared2010: 1 descendant 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 clearedK003286 · Symphony Graft Delivery System · Depuyacromed · 2001200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 2 descendants4 generations forward: 3 descendants5 generations forward: 3 descendants6 generations forward: 7 descendants7 generations forward: 12 descendants8 generations forward: 10 descendants9 generations forward: 4 descendants10 generations forward: 1 descendant K003286 · Symphony Graft Delivery System · Depuyacromed · 20010+5+10
  1. Root · 1 generation backK003286 Symphony Graft Delivery SystemDepuyacromed · 2001
  2. This deviceK021071 PCCS Graft Delivery SystemBiomet, Inc. · 2002
  3. Descendant · cites it directly · 47 of its ownK072330 Controlled Delivery for Osteoplasty (Cdo System) and Graft…Biomet, Inc. · 2007
  4. Descendant · 2 generations on · 45 of its ownK100754 Graft Delivery System Model SA-6115Micromedics, Inc. · 2010
  5. Descendant · 3 generations on · 41 of its ownK111632 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011
  6. Descendant · 4 generations on · 40 of its ownK121476 Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012
  7. Descendant · 4 generations on · 32 of its ownK133021 Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

2003: 12007: 12010: 12011: 22012: 12014: 62015: 22016: 32017: 22018: 32019: 22020: 72021: 22022: 22023: 62024: 52025: 22026: 1
2003high 7 (2020) · low 0 (2004)2026

Most influential descendants

Showing 5 of 49 · See all
  • K072330Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation SystemBiomet, Inc. · 2007 · cites it directly47descendants
  • K100754Graft Delivery System Model SA-6115Micromedics, Inc. · 2010 · 2 generations on45descendants
  • K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2011 · 3 generations on41descendants
  • K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC · 2012 · 4 generations on40descendants
  • K133021Mixing Syringe SystemZimmer Knee Creations, Inc. · 2014 · 4 generations on32descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003286Symphony Graft Delivery SystemDepuyacromed2001—
0 (this device)K021071PCCS Graft Delivery SystemBiomet, Inc.2002—
+1K072330Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation SystemBiomet, Inc.2007—
+2K100754Graft Delivery System Model SA-6115Micromedics, Inc.2010—
+3K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC2011—
+4K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC2012—
+4K133021Mixing Syringe SystemZimmer Knee Creations, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200710
201010
201120
201210
201460
201520
201630
201720
201830
201920
202070
202120
202220
202360
202450
202520
202610
FIG. 1 — Lineage of K021071, 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), 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
*K003286Symphony Graft Delivery SystemDepuyacromed2001—
*K011032Smartjet Bone Graft Liquid Applicator (Spray Tip), Model SK/S, Smartjet Bone Graft…Harvest Technologies, Corp.2001—
*K012868Micromedics Fibrijet Aerosol Applicator
Summary page 3
…Symphony FibriJet (KO03 286) (This submission) Harvest Tech. (K012868) Smartjet (KO11032)…
Micromedics, Inc.2001—

Also cleared against K003286: 6 other devices →

What descends from it? (49)

See all 49

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

NumberDeviceApplicantDecidedDescendants
K072330Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation SystemBiomet, Inc.200747
K140710Biomet Graft Delivery SyringesBiomet Spine (Aka Ebi, LLC)20141
K030555GPS Platelet Separation Kit with Anticoagulant Acd-aBiomet, Inc.20030

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 11, 2007Not classifiedZ-0993-2007OtherThe syringe assembly has an obstruction in the tube that prevents the plunger from being depressed.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K072330 (Biomet, Inc., 2007) has gone furthest, with 47 descendants of its own.
  • 6 other devices also cite its predicate K003286.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

This device is intended for use iflthe delivery of allograft and autograft bone matefials to an orthopedic sttrgical site. In addition, it is designed to facilitate pre-mixing ofbone graft materials with J.V. fluids, blood, plasma, plateiet rich plasma, bone marrow or other specific blood components as deemed necessary by the clinical use requirements.

Indications for use as stated in the FDA summary.

Also cleared against K003286

6 other devices cite the same predicate.

  • K081758Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010, 276175015Depuy Spine, Inc. · 2008
  • K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc. · 2006
  • K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc. · 2006
  • K043261Harvest Graft Delivery SyringeHarvest Technologies, Corp. · 20052 recalls
  • K022246Modification to Symphony Graft Delivery SystemDepuyacromed · 2002
  • K012738Symphony Graft Delivery System (GDS)Depuyacromed · 2001

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

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/K021071 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021071: PCCS Graft Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021071

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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