510(k) Report

510(k) · Cleared

Cleared

Active Anterior Cervical Plate System

K073500510(k) TraditionalCleared Jul 3, 2008203-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

Sanacor · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jul 3, 2008 as substantially equivalent to K062371 (Alphaspine, Inc., 2006) and 8 other predicates after a 203-day review. Its family tree reaches back 4 generations to 1992.

Decided
Jul 3, 2008
Review
203 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
9

Its longest line of descent runs back 4 generations to K922087 (1992). 38 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 2 other ancestors2006: 1 other ancestor2005: 3 other ancestors2003: 2 other ancestors2001: 3 other ancestors1998: 4 other ancestors2004: 3 other ancestors2002: 1 other ancestor2000: 3 other ancestors1997: 5 other ancestors1995: 2 other ancestors1999: 3 other ancestors1993: 2 other ancestorsK922087 · Anterior Cervical Plate System · Sofamor Danek Mfg., Inc. · 1992K990005 · Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System · Spinal Concepts, Inc. · 1999 · recalledK013979 · SC-Acufix Thinline Anterior Cervical Plate System · Spinal Concepts, Inc. · 2002 · recalledK024326 · Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate System · Spinal Concepts, Inc. · 2003 · recalled19901995200020052010
Other ancestors, by generation 1 generation back: 8 other ancestors2 generations back: 14 other ancestors3 generations back: 10 other ancestors4 generations back: 2 other ancestors K024326 · Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate System · Spinal Concepts, Inc. · 2003 · recalledK013979 · SC-Acufix Thinline Anterior Cervical Plate System · Spinal Concepts, Inc. · 2002 · recalledK990005 · Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System · Spinal Concepts, Inc. · 1999 · recalledK922087 · Anterior Cervical Plate System · Sofamor Danek Mfg., Inc. · 19920
  1. Root · 4 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
  2. 3 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
  3. 2 generations backK013979 SC-Acufix Thinline Anterior Cervical Plate SystemSpinal Concepts, Inc. · 2002 · Recalled
  4. 1 generation backK024326 Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate SystemSpinal Concepts, Inc. · 2003 · Recalled
  5. This deviceK073500 Active Anterior Cervical Plate SystemSanacor · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K922087Anterior Cervical Plate SystemSofamor Danek Mfg., Inc.1992—
−3K990005Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc.19991
−2K013979SC-Acufix Thinline Anterior Cervical Plate SystemSpinal Concepts, Inc.20022
−1K024326Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate SystemSpinal Concepts, Inc.20034
0 (this device)K073500Active Anterior Cervical Plate SystemSanacor2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199320
199520
199750
199840
199930
200030
200130
200210
200320
200430
200530
200610
200720
FIG. 1 — Lineage of K073500, 1992–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (9)

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
*K062371Preview Anterior Cervical Plate System
Summary page 1
…y equivalent to the following systems which are currently marketed and distributed in the US: PreView Anterior Cervical Plate (K0623 7 1), Sanacor CSLP (K03 0866), Synthes DOC VCSS (K982443), DePuy Spine…
Alphaspine, Inc.2006—
*K030866Synthes Anterior CSLP System
Summary page 1
…which are currently marketed and distributed in the US: PreView Anterior Cervical Plate (K0623 7 1), Sanacor CSLP (K03 0866), Synthes DOC VCSS (K982443), DePuy Spine C-Jaws Cervical Compression Mini Frame (K06…
Synthes (Usa)2003—
*K982443Doc Ventral Cervical Stabilization System
Summary page 1
…uted in the US: PreView Anterior Cervical Plate (K0623 7 1), Sanacor CSLP (K03 0866), Synthes DOC VCSS (K982443), DePuy Spine C-Jaws Cervical Compression Mini Frame (K062 181 Medicrea Technologies…
Depuy Motech Acromed1998—
*K062181C-Jaws Cervical Compressive Mini Frame
Summary page 1
…anacor CSLP (K03 0866), Synthes DOC VCSS (K982443), DePuy Spine C-Jaws Cervical Compression Mini Frame (K062 181 Medicrea Technologies OSStaple Staple System (K061385), BioMedical Enterprises, Inc.…
Medicrea Technologies2007—
*K061385Osstaple, Ossplate, Ossforce
Summary page 1
…uy Spine C-Jaws Cervical Compression Mini Frame (K062 181 Medicrea Technologies OSStaple Staple System (K061385), BioMedical Enterprises, Inc. Pioneer Anterior Cervical Plate System (K043 066) Pion…
Biomedical Enterprises, Inc.2007—
*K043066Pioneer Anterior Cervical Plate System
Summary page 1
…Medicrea Technologies OSStaple Staple System (K061385), BioMedical Enterprises, Inc. Pioneer Anterior Cervical Plate System (K043 066) Pioneer Surgical Technology Ant-Cer Dynamic Anterior Cervical Plate System (K0243 26…
Pioneer Surgical Technology2005—
*K024326Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate System
Summary page 1
…Pioneer Anterior Cervical Plate System (K043 066) Pioneer Surgical Technology Ant-Cer Dynamic Anterior Cervical Plate System (K0243 26) Spinal Concepts, Inc. Synthes Vectra-T System (K05 1665), Synthes Spine…
Spinal Concepts, Inc.20034
*K051665Synthes Vectra-T System
Summary page 1
…Ant-Cer Dynamic Anterior Cervical Plate System (K0243 26) Spinal Concepts, Inc. Synthes Vectra-T System (K05 1665), Synthes Spine C3 Anterior CervicalPlate System (KO 128 8 1), Spine Vision…
Synthes Spine20052
*K012881C3 Anterior Cervical Plate System
Summary page 2
…Pioneer (K043066) - Compression applied to bone graft OSStaple (K061385), C-JAWS (K062181), C3 (K012881) All of these technologies are substantially equivalent to those found among the pre…
Spine Vision, Inc.2001—

Also cleared against K062371: 1 other device →

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 16 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
  • 8 of the 38 ancestors have a recall of any class.
  • 1 other device also cites its predicate K062371.

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. 2008, 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?

The Active TM Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1) with removal of the implants after the attainment of a solid fusion mass. The Active TM Anterior Cervical Plate System is intended for use under the following indications: · Degenerative disc disease (DDD)…

Read the full statement (118 words)

The Active TM Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1) with removal of the implants after the attainment of a solid fusion mass. The Active TM Anterior Cervical Plate System is intended for use under the following indications:

· Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient 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

* Failed previous fusion

Indications for use as stated in the FDA summary.

Also cleared against K062371

1 other device cites the same predicate.

  • K223627PreView-III™ Anterior Cervical Plate SystemNexus Spine, LLC · 2023

More from Sanacor

3 FDA decisions under this applicant name. See the company

  • K090477Alpine Pedicle Screw SystemSanacor · 2009
  • K070933Lowtop Pedicle Screw SystemSanacor · 2007

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/K073500 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073500: Active Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073500

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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