510(k) Report

510(k) · Cleared

Cleared

Medicrea International Anterior Lumbar Plate

K121323510(k) TraditionalCleared Jul 18, 201277-day reviewClass II21 CFR 888.3060

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

Medicrea International · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jul 18, 2012 as substantially equivalent to K101255 (Alphatec Spine, Inc., 2010) and 2 other predicates after a 77-day review. Its family tree reaches back 7 generations to 1993.

Decided
Jul 18, 2012
Review
77 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
3

Its longest line of descent runs back 7 generations to K922543 (1993). 17 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2007: 1 other ancestor2006: 2 other ancestors2002: 3 other ancestors2001: 1 other ancestor2000: 1 other ancestor1997: 1 other ancestorK922543 · Z-Plate Anterior Fixation System · Sofamor Danek Mfg., Inc. · 1993K013665 · Pyramid Anterior Plate Fixation System · Medtronic Sofamor Danek, Inc. · 2002K043548 · Blackstone Unity Anterior Lumbar Plate Fixation System · Blackstone Medical, Inc. · 2005K061229 · Unity LX Anterolateral Lumbar Plate Fixation System · Blackstone Medical, Inc. · 2006K070922 · Modification to Spinal Usa VBR System · Spinal USA · 2007K091044 · Spinal Usa Anterior Lumbar Plate System · Spinal USA · 2009K101255 · Alphatec Spine Anterior Lumbar Plating System · Alphatec Spine, Inc. · 201019901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 6 other ancestors4 generations back: 2 other ancestors K101255 · Alphatec Spine Anterior Lumbar Plating System · Alphatec Spine, Inc. · 2010K091044 · Spinal Usa Anterior Lumbar Plate System · Spinal USA · 2009K070922 · Modification to Spinal Usa VBR System · Spinal USA · 2007K061229 · Unity LX Anterolateral Lumbar Plate Fixation System · Blackstone Medical, Inc. · 2006K043548 · Blackstone Unity Anterior Lumbar Plate Fixation System · Blackstone Medical, Inc. · 2005K013665 · Pyramid Anterior Plate Fixation System · Medtronic Sofamor Danek, Inc. · 2002K922543 · Z-Plate Anterior Fixation System · Sofamor Danek Mfg., Inc. · 1993−50
  1. Root · 7 generations backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
  2. 6 generations backK013665 Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
  3. 5 generations backK043548 Blackstone Unity Anterior Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2005
  4. 4 generations backK061229 Unity LX Anterolateral Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2006
  5. 3 generations backK070922 Modification to Spinal Usa VBR SystemSpinal USA · 2007
  6. 2 generations backK091044 Spinal Usa Anterior Lumbar Plate SystemSpinal USA · 2009
  7. 1 generation backK101255 Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc. · 2010
  8. This deviceK121323 Medicrea International Anterior Lumbar PlateMedicrea International · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K922543Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc.1993—
−6K013665Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc.2002—
−5K043548Blackstone Unity Anterior Lumbar Plate Fixation SystemBlackstone Medical, Inc.2005—
−4K061229Unity LX Anterolateral Lumbar Plate Fixation SystemBlackstone Medical, Inc.2006—
−3K070922Modification to Spinal Usa VBR SystemSpinal USA2007—
−2K091044Spinal Usa Anterior Lumbar Plate SystemSpinal USA2009—
−1K101255Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc.2010—
0 (this device)K121323Medicrea International Anterior Lumbar PlateMedicrea International2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200010
200110
200230
200620
200710
200810
FIG. 1 — Lineage of K121323, 1993–2012Source: 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 KWQ? 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 KWQ device

  1. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 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
*K101255Alphatec Spine Anterior Lumbar Plating System
Summary page 1
…tervertebral Body. 3. Predicate or legally marketed devices which are substantially equivalent: * The Alphatec Spine Anterior Lumbar Plating System, (Alphatec Spine, K101255) * The Spinal USA Anterior Lumbar Plate System (Spinal USA, K091044) * The Pyramido +4 Anterior Lumbar Plate System (MEDTRO…
Alphatec Spine, Inc.2010—
*K091044Spinal Usa Anterior Lumbar Plate System
Summary page 1
…substantially equivalent: * The Alphatec Spine Anterior Lumbar Plating System, (Alphatec Spine, K101255) * The Spinal USA Anterior Lumbar Plate System (Spinal USA, K091044) * The Pyramido +4 Anterior Lumbar Plate System (MEDTRONIC, K080429) 4. Description of the device: The MEDICREA® Anterior Lu…
Spinal USA2009—
*K080429Modificaton to: Pyramid +4 Anterior Lumbar Plate System
Summary page 1
…ng System, (Alphatec Spine, K101255) * The Spinal USA Anterior Lumbar Plate System (Spinal USA, K091044) * The Pyramido +4 Anterior Lumbar Plate System (MEDTRONIC, K080429) 4. Description of the device: The MEDICREA® Anterior Lumbo sacral Plate system is a stabilization device for use as an adjunct…
Medtronic Sofamor Danek USA, Inc.2008—

Also cleared against K101255: 2 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)

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 19 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
  • 1 of the 17 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K101255.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

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

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, 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
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

What is it indicated for?

MEDICREAS INTERNATIONAL anterior lumbo-sacral plate system is designed to be used at L5/S1 level. It is intended for use as anteriorly placed supplemental fixation device via the anterior surgical approach below the great vessel bifurcation. The device is intended as a temporary fixation device until fusion is achieved. MEDICREA® INTERNATIONAL anterior lumbo-sacral plate system is intended for anterior lumbar spine at L5/S1 level, for the following…

Read the full statement (168 words)

MEDICREAS INTERNATIONAL anterior lumbo-sacral plate system is designed to be used at L5/S1 level. It is intended for use as anteriorly placed supplemental fixation device via the anterior surgical approach below the great vessel bifurcation. The device is intended as a temporary fixation device until fusion is achieved.

MEDICREA® INTERNATIONAL anterior lumbo-sacral plate system is intended for anterior lumbar spine at L5/S1 level, for the following indications:

1. Degenerative Disc Disease (ODD) at L5/SI level. (ODD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies)

2. Pseudoarthrosis

3. Spondylolysis

4. Trauma (i.e., fracture or dislocation)

5. Spinal stenosis

6. Deformities and or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)

7. Tumor

8. Failed previous fusion.

MEDICREAS INTERNATIONAL anterior lumbo-sacral plate is intended to be used with autograft and or allograft as an adjunct to fusion.

Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage and a lumbo-sacral plate for degenerative conditions.

Indications for use as stated in the FDA summary.

Also cleared against K101255

2 other devices cite the same predicate.

  • K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
  • K182808Aspida® Anterior Lumbar Plating SystemAlphatec Spine, Inc. · 2018

More from Medicrea International

17 FDA decisions under this applicant name. See the company

  • K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International · 2022
  • K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International · 2022
  • K180091UNiD Spine AnalyzerMedicrea International · 2018
  • K170172UNiD Spine AnalyzerMedicrea International · 2017
  • K153169PASS OCT Patient Specific RodsMedicrea International · 2016

Recent decisions in KWQ

The KWQ category page

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https://510kreport.com/device/K121323 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121323: Medicrea International Anterior Lumbar Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121323

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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