510(k) Report

510(k) · Cleared

Cleared

MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System

K162194510(k) TraditionalCleared Dec 8, 2016125-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 SA · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Dec 8, 2016 as substantially equivalent to K133518 (Biomet Spine (Aka Ebi, LLC), 2014) and 3 other predicates after a 125-day review. Its family tree reaches back 6 generations to 1995.

Decided
Dec 8, 2016
Review
125 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K953730 (1995). 16 ancestors in all, the oldest K914362 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor2005: 1 other ancestor2003: 1 other ancestor2008: 1 other ancestor2004: 2 other ancestors2007: 1 other ancestor2006: 1 other ancestor1997: 1 other ancestor1992: 1 other ancestorK953730 · Codman Anterior Cervical Plate System · Johnson & Johnson Professionals, Inc. · 1995K013877 · Codman Slim-Loc System · Codman & Shurtleff, Inc. · 2001K040655 · Swift Anterior Cervical Plate System · Depuy Spine, Inc. · 2004K072546 · Swift Plus Anterior Cervical Plate System · Depuy Spine, Inc. · 2007K080646 · C-Tek Maxan Anterior Cervical Plate System · Biomet Spine · 2008 · recalledK133518 · Maxan Anterior Cervical Plate System · Biomet Spine (Aka Ebi, LLC) · 2014 · recalled199019952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors3 generations back: 4 other ancestors K133518 · Maxan Anterior Cervical Plate System · Biomet Spine (Aka Ebi, LLC) · 2014 · recalledK080646 · C-Tek Maxan Anterior Cervical Plate System · Biomet Spine · 2008 · recalledK072546 · Swift Plus Anterior Cervical Plate System · Depuy Spine, Inc. · 2007K040655 · Swift Anterior Cervical Plate System · Depuy Spine, Inc. · 2004K013877 · Codman Slim-Loc System · Codman & Shurtleff, Inc. · 2001K953730 · Codman Anterior Cervical Plate System · Johnson & Johnson Professionals, Inc. · 1995−50
  1. Root · 6 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
  2. 5 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
  3. 4 generations backK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
  4. 3 generations backK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
  5. 2 generations backK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
  6. 1 generation backK133518 Maxan Anterior Cervical Plate SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
  7. This deviceK162194 MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K953730Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc.1995—
−5K013877Codman Slim-Loc SystemCodman & Shurtleff, Inc.2001—
−4K040655Swift Anterior Cervical Plate SystemDepuy Spine, Inc.2004—
−3K072546Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc.2007—
−2K080646C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine20082
−1K133518Maxan Anterior Cervical Plate SystemBiomet Spine (Aka Ebi, LLC)20141
0 (this device)K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199710
200310
200420
200510
200610
200710
200810
201010
FIG. 1 — Lineage of K162194, 1995–2016Source: 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
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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
*K133518Maxan Anterior Cervical Plate System
Summary page 4
…de: KWQ Class Il 3. Predicate or legally marketed devices which are substantially equivalent: Primary predicate: e MaxAn Anterior Cervical Plate System, (BIOMET SPINE, K133518) Additional predicate: e Stella Cervical Plate, (SCIENT’X, K052763) e Synthes Spine Anterior CSLP System (SYNTHES SPINE, KO308…
Biomet Spine (Aka Ebi, LLC)20141
*K052763Stella Cervical Plate
Summary page 4
…substantially equivalent: Primary predicate: e MaxAn Anterior Cervical Plate System, (BIOMET SPINE, K133518) Additional predicate: e Stella Cervical Plate, (SCIENT’X, K052763) e Synthes Spine Anterior CSLP System (SYNTHES SPINE, KO30866) e Uniplate Anterior Cervical Plate System (DEPUY SPINE, K100070)…
Scient'X2005—
*K030866Synthes Anterior CSLP System
Summary page 6
…NT’X Device Anterior Cervical Anterior CSLP c Ar_rtenc;: STELLA Locking Plate | Cervical System ervical Plate | coryical plate System Plate System 510(k) Unknown K133518 K030866 K100070 K132012 number Intended use Anterior Yes Yes Yes Yes Yes Cervical Components 1-Level Plate 1-Level Plate | 1-Level Plate…
Synthes (Usa)2003—
*K100070Uniplate Anterior Cervical Plate System
Summary page 4
…ate: e Stella Cervical Plate, (SCIENT’X, K052763) e Synthes Spine Anterior CSLP System (SYNTHES SPINE, KO30866) e Uniplate Anterior Cervical Plate System (DEPUY SPINE, K100070) No reference devices were used in this submission. 4. Description of the device: MEDICREA INTERNATIONAL Anterior Cervical Loc…
Depuy Spine, Inc.2010—

Also cleared against K133518: 11 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 21 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
  • 2 of the 16 ancestors have a recall of any class.
  • 11 other devices also cite its predicate K133518.

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. 2016, 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?

MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is intended for anterior interbody screw/plate fixation of the cervical spine until the bone fusion occurs. The MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is indicated for use in the temporary stabilization of the anterior cervical (C2 to T1) spine during development of a solid fusion in patients with the following conditions: • degenerative disc disease (DDD)…

Read the full statement (141 words)

MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is intended for anterior interbody screw/plate fixation of the cervical spine until the bone fusion occurs.

The MEDICREA INTERNATIONAL S.A. Anterior Cervical Locking Plate System is indicated for use in the temporary stabilization of the anterior cervical (C2 to T1) spine during development of a solid fusion in patients with the following conditions:

• degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),

• spondylolisthesis,

• trauma (i.e., fracture or dislocation),

• spinal stenosis,

• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

• tumor,

• pseudoarthrosis,

• and failed previous fusion

This implant has to be used with an appropriate bone graft.

Patients should have been unresponsive for a minimum six (6) weeks to conservative treatment before the surgery.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K133518

11 other devices cite the same predicate.

  • K240515uNion® MAX Cervical Plate SystemUlrich Medical USA, Inc. · 2024
  • K221053Magnes-C Anterior Cervical Plate SystemFellowship of Orthopaedic Researchers, Inc. · 2023
  • K200927Transept Cervical Plate SystemNeurostructures, Inc. · 2020
  • K201029Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemSpinal Elements, Inc. · 2020
  • K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc. · 202029 recalls
  • K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc. · 2019

More from Medicrea International SA

25 FDA decisions under this applicant name. See the company

  • K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA · 2022
  • K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA · 2022
  • K210470C-CURVE Interbody Fusion DeviceMedicrea International SA · 2021
  • K200316UNiD IB3D ALIFMedicrea International SA · 2020
  • K191134IB3D AlifMedicrea International SA · 2019

Recent decisions in KWQ

The KWQ category page

  • K262149corra® cervical plating systemCarlsmed, Inc. · 2026
  • K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026
  • K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
  • K260570corra™ cervical plating systemCarlsmed, Inc. · 2026

https://510kreport.com/device/K162194 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162194: MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162194

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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