510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Impix Lumbar Interbody Device

K100544510(k) SpecialCleared Jul 22, 2010147-day reviewClass II21 CFR 888.3080Recalls 1

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 Jul 22, 2010 as substantially equivalent to K072226 (Medicrea Technologies, 2007) and 3 other predicates after a 147-day review. Its family tree reaches back 10 generations to 1984. It has been recalled once.

Decided
Jul 22, 2010
Review
147 days
Class
Class II
Product code
MAX
Recalls
1
Predicates
4

Its longest line of descent runs back 10 generations to K841189 (1984). 40 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2007: 5 other ancestors2006: 1 other ancestor2005: 2 other ancestors2001: 6 other ancestors1999: 2 other ancestors1996: 1 other ancestor2004: 5 other ancestors2002: 4 other ancestors2000: 1 other ancestor2003: 2 other ancestorsK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K073177 · Pioneer Intervertebral Fusion Device System · Pioneer Surgical Technology · 2008 · recalled1980198519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 8 other ancestors3 generations back: 5 other ancestors4 generations back: 5 other ancestors5 generations back: 5 other ancestors6 generations back: 3 other ancestors7 generations back: 1 other ancestor K073177 · Pioneer Intervertebral Fusion Device System · Pioneer Surgical Technology · 2008 · recalledK072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−10−50
  1. Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 6 generations between
  3. 3 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  4. 2 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  5. 1 generation backK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
  6. This deviceK100544 Impix Lumbar Interbody DeviceMedicrea Technologies · 2010
Show all 10 generations
  1. Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 5 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 4 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 3 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 2 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 1 generation backK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
  11. This deviceK100544 Impix Lumbar Interbody DeviceMedicrea Technologies · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−9K990148Stackable Cage SystemDepuy Motech Acromed1999—
−8K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−7K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−6K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−5K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−4K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−3K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−2K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−1K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20081
0 (this device)K100544Impix Lumbar Interbody DeviceMedicrea Technologies2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199920
200010
200160
200240
200320
200450
200520
200610
200750
200810
FIG. 1 — Lineage of K100544, 1984–2010Source: 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 MAX? 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
Get a 510(k) Report

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
*K072226Impix Spacer
Summary page 1
…ntervertebral body fusion device - lumbar 3. Predicate or legally marketed devices which are substantially equivalent: • The IMPIX-L Lumbar Cages (MEDICREA, K072226) * The ORACLE Spacer (Synthes, K072797) *•TheCROSS-FUSE (Pioneer, K073177) * The Vu-a-Pod (Theken spine,…
Medicrea Technologies2007—
*K072791Oracle Spacer, Opal Spacer
Our reading of the summary gave K072797, FDA’s number for GE Logiq I Comapact Ultrasound, GE Logiq E Compact… (General Electric Co.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ORACLE Spacer”.
Synthes Spine20071
*K073177Pioneer Intervertebral Fusion Device System
Summary page 1
…ich are substantially equivalent: • The IMPIX-L Lumbar Cages (MEDICREA, K072226) * The ORACLE Spacer (Synthes, K072797) *•TheCROSS-FUSE (Pioneer, K073177) * The Vu-a-Pod (Theken spine, K080822) 4. Description of the device: The purpose of this submission…
Pioneer Surgical Technology20081
*K080822VU Apod Intervertabral Body Fusion Device
Summary page 1
…IMPIX-L Lumbar Cages (MEDICREA, K072226) * The ORACLE Spacer (Synthes, K072797) *•TheCROSS-FUSE (Pioneer, K073177) * The Vu-a-Pod (Theken spine, K080822) 4. Description of the device: The purpose of this submission is to submit the new Lumbar Interbody device: I…
Theken Spine, LLC20081

Also cleared against K072226: 10 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Jul 12, 2023Class IIZ-2455-2023Under Investigation by firmThere is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 26 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
  • 9 of the 40 ancestors have a recall of any class.
  • 10 other devices also cite its predicate K072226.

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. 2010, 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 DLIF Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels from L2-S1. DDID 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 DLIF 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 K072226

10 other devices cite the same predicate.

  • K163595IMPIX 3D Print CagesMedicrea International SA · 20172 recalls
  • K141187Impix Alif S/aMedicrea International SA · 20151 recall
  • K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd. · 2014
  • K130853Idys (TM) CClariance · 2013
  • K110067LP CageMedyssey Co, Ltd. · 2011
  • K083798Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar IbfMedicrea Technologies · 20102 recalls

More from Medicrea Technologies

14 FDA decisions under this applicant name. See the company

  • K102406Pass Anterior Spinal SystemMedicrea Technologies · 2011
  • 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
  • K083308Pass LP Spinal SystemMedicrea Technologies · 2008

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/K100544 · printed Nov 5, 2026

Cite this page

510(k) Report. “K100544: Impix Lumbar Interbody Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100544

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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