510(k) Report

510(k) · Cleared

Cleared

Impix Spacer

K072226510(k) TraditionalCleared Dec 10, 2007122-day reviewClass II21 CFR 888.3080

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

Medicrea Technologies · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Dec 10, 2007 as substantially equivalent to P980048 (Sulzer Spine-Tech, 2001) and 3 other predicates after a 122-day review. Its family tree reaches back 1 generation to 1996. 1 of the 817 devices in its family, counting itself, has a Class I recall. 812 later devices descend from it.

Decided
Dec 10, 2007
Review
122 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to P950002 (1996). 4 ancestors in all. 812 later devices descend from it, 11 citing it directly. 1 of the 817 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1999: 2 other ancestors2009: 1 descendant cleared2013: 8 descendants cleared2015: 22 descendants cleared2008: 3 descendants cleared2010: 4 descendants cleared2017: 54 descendants cleared2014: 16 descendants cleared2011: 5 descendants cleared2012: 4 descendants cleared2021: 69 descendants cleared, 1 with a Class I recall12022: 74 descendants cleared2018: 50 descendants cleared2019: 60 descendants cleared2024: 95 descendants cleared2016: 36 descendants cleared2020: 80 descendants cleared2025: 78 descendants cleared2023: 88 descendants cleared2026: 65 descendants clearedP950002 · Bak Interbody Fusion System · Zimmer Spine, Inc. · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 11 descendants2 generations forward: 26 descendants3 generations forward: 45 descendants4 generations forward: 79 descendants5 generations forward: 144 descendants6 generations forward: 188 descendants, 1 with a Class I recall17 generations forward: 163 descendants8 generations forward: 81 descendants9 generations forward: 47 descendants10 generations forward: 19 descendants11 generations forward: 7 descendants12 generations forward: 2 descendants P950002 · Bak Interbody Fusion System · Zimmer Spine, Inc. · 19960+5+10
  1. Root · 1 generation backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
  2. This deviceK072226 Impix SpacerMedicrea Technologies · 2007
  3. Descendant · cites it directly · 775 of its ownK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
  4. Descendant · 2 generations on · 604 of its ownK112496 Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc. · 2011
  5. Descendant · 2 generations on · 598 of its ownK133623 C-PLUSPioneer Surgical Technology, Inc. · 2014
  6. Descendant · 2 generations on · 596 of its ownK133455 Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc. · 2014 · Recalled
  7. Descendant · 3 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015

Showing 5 of 812 descendants. See all descendants

Descendants cleared per year

2008: 32009: 12010: 42011: 52012: 42013: 82014: 162015: 222016: 362017: 542018: 502019: 602020: 802021: 692022: 742023: 882024: 952025: 782026: 65
2008high 95 (2024) · low 1 (2009)2026

Class I recalls in this family

  • K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 812 · See all
  • K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · cites it directly775descendants
  • K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc. · 2011 · 2 generations on604descendants
  • K133623C-PLUSPioneer Surgical Technology, Inc. · 2014 · 2 generations on598descendants
  • K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc. · 2014 · 2 generations on596descendants
  • K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 3 generations on588descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1P950002Bak Interbody Fusion SystemZimmer Spine, Inc.1996—
0 (this device)K072226Impix SpacerMedicrea Technologies2007—
+1K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20081
+2K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011—
+2K133623C-PLUSPioneer Surgical Technology, Inc.2014—
+2K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20141
+3K141665NuVasive CoRoent SystemNuvasive, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199920
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200830
200910
201040
201150
201240
201380
2014160
2015220
2016360
2017540
2018500
2019600
2020800
2021691
2022740
2023880
2024950
2025780
2026650
FIG. 1 — Lineage of K072226, 1996–2026Source: 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.

1 device in this family has a Class I recall. 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 MAX device

  1. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (4)

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
*P980048Bak/Cervical (Bak/C) Interbody Fusion System
Summary page 1
…Orthopedic Legally marketed predicate 1. BAK'C Vista Interbody Fusion - peek-optima Iti, Zimmer Spine, Inc devices (P980048 S003) 2. BRANTIGEN I/F CAGE, DePuy Spine Inc, (P960025) 3. LT-C…
Sulzer Spine-Tech2001—
*P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws
Summary page 1
…usion - peek-optima Iti, Zimmer Spine, Inc devices (P980048 S003) 2. BRANTIGEN I/F CAGE, DePuy Spine Inc, (P960025) 3. LT-CAGE PEEK LUMBAR - peek-optima Iti, Medtronic (P970015…
Depuy Spine, Inc.1999—
*P970015Inter Fix Threaded Fusion Device
Summary page 1
…2. BRANTIGEN I/F CAGE, DePuy Spine Inc, (P960025) 3. LT-CAGE PEEK LUMBAR - peek-optima Iti, Medtronic (P970015 S022) 4. BAK INTERBODY LUMBAR FUSION - 65% peek optima/35%…
Sofamor Danek19991
*P950002Bak Interbody Fusion System
Summary page 1
…S022) 4. BAK INTERBODY LUMBAR FUSION - 65% peek optima/35% carbon fiber, Zimmer Spine (P950002 S011i) Submitter MEDICREA TM Technologies Z.i. Chef de Bale…
Zimmer Spine, Inc.1996—

Also cleared against P980048: 53 other devices →

What descends from it? (812)

See all 812

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

NumberDeviceApplicantDecidedDescendants
K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology2008775
K083798Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar IbfMedicrea Technologies201032
K163595IMPIX 3D Print CagesMedicrea International SA201728
K110067LP CageMedyssey Co, Ltd.201115
K083167Phenix Cervical Interbody DeviceSpinal Devices, LLC200914
K081196Spinal Usa VBR SystemSpinal USA200813
K130853Idys (TM) CClariance20132
K141187Impix Alif S/aMedicrea International SA20150
K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140
K100544Impix Lumbar Interbody DeviceMedicrea Technologies20100

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K073177 (Pioneer Surgical Technology, 2008) has gone furthest, with 775 descendants of its own.
  • 53 other devices also cite its predicate P980048.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

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

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, 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
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

IMPIX-C Cervical Interbody Device is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C3-C7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is to be used with autogenous bone graft. IMPIX-C Cervical Interbody Device is to be used with supplemental fixation. Patients should have…

Read the full statement (188 words)

IMPIX-C Cervical Interbody Device is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C3-C7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is to be used with autogenous bone graft.

IMPIX-C Cervical Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

IMPIX-L Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft.

IMPIX-L Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Indications for use as stated in the FDA summary.

Also cleared against P980048

53 other devices cite the same predicate.

  • K253260ORIO-3D Cage SystemSpineCraft · 2026
  • K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC · 2021
  • K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
  • K182477Cervical SpacerAdditive Implants, LLC · 2019
  • K181471ACCUFUSE Cervical SystemAbsolute Advantage Medical, LLC · 2018
  • K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018

More from Medicrea Technologies

14 FDA decisions under this applicant name. See the company

  • K102406Pass Anterior Spinal SystemMedicrea Technologies · 2011
  • K100544Impix Lumbar Interbody DeviceMedicrea Technologies · 20101 recall
  • K083798Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar IbfMedicrea Technologies · 20102 recalls
  • K100297Pass LP Spinal SystemMedicrea Technologies · 2010
  • K083810Pass LP Spinal SystemMedicrea Technologies · 2009

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K072226 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072226: Impix Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072226

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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