510(k) Report

510(k) · Cleared

Cleared

White Pearl Preferred Angle Anterior Cervical Plate

K160522510(k) TraditionalCleared Apr 26, 201661-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

Osseus Fusion Systems, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Apr 26, 2016 as substantially equivalent to K132012 (Zimmer Spine, Inc., 2013) and 6 other predicates after a 61-day review. Its family tree reaches back 15 generations to 2001.

Decided
Apr 26, 2016
Review
61 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
7

Its longest line of descent runs back 15 generations to K003155 (2001). 112 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2013: 1 other ancestor2010: 1 other ancestor2008: 8 other ancestors2006: 5 other ancestors2004: 17 other ancestors2000: 4 other ancestors2012: 1 other ancestor2011: 2 other ancestors2003: 13 other ancestors2002: 7 other ancestors2001: 8 other ancestors1992: 1 other ancestor2009: 5 other ancestors2007: 4 other ancestors2005: 7 other ancestors1999: 2 other ancestors1998: 2 other ancestors1997: 2 other ancestors1995: 1 other ancestor1996: 2 other ancestors1993: 1 other ancestor1984: 1 other ancestor1980: 1 other ancestor1979: 1 other ancestorK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×3: 3 generations cleared close together, K021791 (2002), K023570 (2002), K030601 (2003) ×2: 2 generations cleared close together, K040536 (2004), K041556 (2004) K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K060719 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K062133 · Modification to Verte-Stack Spinal System · Medtronic Spinal and Biologics Div · 2006K070173 · Verte-Stack Spinal System · Medtronic Sofamor Danek, Inc. · 2007K073285 · Peek Prevail Cervical Interbody Device · Medtronic Sofamor Danek USA, Inc. · 2008K094042 · Peek Prevail Cervical Interbody Device · Medtronic Sofamor Danek · 2010K112388 · Lanx Cervical SA · Lanx, Inc. · 2011K132894 · Optio-C Anterior Cervical System · Zimmer Spine, Inc. · 20141980199020002010
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 11 other ancestors3 generations back: 22 other ancestors4 generations back: 23 other ancestors5 generations back: 13 other ancestors6 generations back: 10 other ancestors7 generations back: 8 other ancestors8 generations back: 4 other ancestors K132894 · Optio-C Anterior Cervical System · Zimmer Spine, Inc. · 2014K112388 · Lanx Cervical SA · Lanx, Inc. · 2011K094042 · Peek Prevail Cervical Interbody Device · Medtronic Sofamor Danek · 2010K073285 · Peek Prevail Cervical Interbody Device · Medtronic Sofamor Danek USA, Inc. · 2008K070173 · Verte-Stack Spinal System · Medtronic Sofamor Danek, Inc. · 2007K062133 · Modification to Verte-Stack Spinal System · Medtronic Spinal and Biologics Div · 2006K060719 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K041556 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K040536 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K030601 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K023570 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K021791 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K012254 · VBR · Osteotech, Inc. · 2001K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001−15−10−50
  1. Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 11 generations between
  3. 3 generations backK094042 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek · 2010
  4. 2 generations backK112388 Lanx Cervical SALanx, Inc. · 2011
  5. 1 generation backK132894 Optio-C Anterior Cervical SystemZimmer Spine, Inc. · 2014
  6. This deviceK160522 White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC · 2016
Show all 15 generations
  1. Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 14 generations backK012254 VBROsteotech, Inc. · 2001
  3. 13 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 12 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 11 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 10 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 9 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 8 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 7 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 6 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
  11. 5 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
  12. 4 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
  13. 3 generations backK094042 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek · 2010
  14. 2 generations backK112388 Lanx Cervical SALanx, Inc. · 2011
  15. 1 generation backK132894 Optio-C Anterior Cervical SystemZimmer Spine, Inc. · 2014
  16. This deviceK160522 White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−15K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−14K012254VBROsteotech, Inc.2001—
−13K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−12K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−11K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−10K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−9K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−8K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−7K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−6K062133Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div2006—
−5K070173Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2007—
−4K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008—
−3K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2010—
−2K112388Lanx Cervical SALanx, Inc.2011—
−1K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.2014—
0 (this device)K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
198410
199210
199310
199510
199620
199720
199820
199920
200040
200180
200270
2003130
2004170
200570
200650
200740
200880
200950
201010
201120
201210
201310
FIG. 1 — Lineage of K160522, 2001–2016Source: 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
Get a 510(k) Report

What was it cleared against? (7)

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
*K132012Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior Cervical Plate…
Summary page 4
…FR Section 21 CFR section 888.3060 Device Panel Orthopedic Primary Predicate Zimmer Trinica/Trinica Select Anterior Cervical Plate System (K132012) Device Spinal USA Slimpicity Anterior Cervical Plate System (K060025) Additional Predicate Synthes A…
Zimmer Spine, Inc.2013—
*K060025Slimplicity Anterior Cervical Plate System
Summary page 4
…dicate Zimmer Trinica/Trinica Select Anterior Cervical Plate System (K132012) Device Spinal USA Slimpicity Anterior Cervical Plate System (K060025) Additional Predicate Synthes Anterior CSLP System (K000536) Devices DePuy UNIPLATE Anterior Cervical Plate (K…
Spinal USA2006—
*K000536Synthes Anterior CSLP System
Summary page 4
…ate System (K132012) Device Spinal USA Slimpicity Anterior Cervical Plate System (K060025) Additional Predicate Synthes Anterior CSLP System (K000536) Devices DePuy UNIPLATE Anterior Cervical Plate (K042544 / K082273 / K100070) Zimmer Opti…
Synthes Spine20001
*K042544Uniplate Anterior Cervical Plate System
Summary page 4
…y Anterior Cervical Plate System (K060025) Additional Predicate Synthes Anterior CSLP System (K000536) Devices DePuy UNIPLATE Anterior Cervical Plate (K042544 / K082273 / K100070) Zimmer Optio-C Anterior Cervical System (K132894) The White…
Depuy Spine, Inc.2004—
*K082273Uniplate Anterior Cervical Plate System
Summary page 4
…Cervical Plate System (K060025) Additional Predicate Synthes Anterior CSLP System (K000536) Devices DePuy UNIPLATE Anterior Cervical Plate (K042544 / K082273 / K100070) Zimmer Optio-C Anterior Cervical System (K132894) The White Pearl Pre…
Depuy Spine, Inc.2008—
*K100070Uniplate Anterior Cervical Plate System
Summary page 4
…Plate System (K060025) Additional Predicate Synthes Anterior CSLP System (K000536) Devices DePuy UNIPLATE Anterior Cervical Plate (K042544 / K082273 / K100070) Zimmer Optio-C Anterior Cervical System (K132894) The White Pearl Preferred Ang…
Depuy Spine, Inc.2010—
*K132894Optio-C Anterior Cervical System
Summary page 4
…m (K000536) Devices DePuy UNIPLATE Anterior Cervical Plate (K042544 / K082273 / K100070) Zimmer Optio-C Anterior Cervical System (K132894) The White Pearl Preferred Angle Anterior Cervical Plate consist of cervical pla…
Zimmer Spine, Inc.2014—

Also cleared against K132012: 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 15 years and passes through 8 companies; a new generation was cleared every 10 months on median.
  • 8 of the 112 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K132012.

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?

The White Pearl Preferred Angle Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with…

Read the full statement (114 words)

The White Pearl Preferred Angle Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

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

• spondylolisthesis,

• trauma (i.e. fractures or dislocations),

• tumors,

• deformity (defined as kyphosis, lordosis, or scoliosis),

• pseudarthrosis,

• failed previous fusion,

• spinal stenosis

Indications for use as stated in the FDA summary.

Also cleared against K132012

2 other devices cite the same predicate.

  • K160702ZION Anterior Cervical Fixation SystemAstura Medical · 2016
  • K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix…Zimmer Spine, Inc. · 2015

More from Osseus Fusion Systems, LLC

5 FDA decisions under this applicant name. See the company

  • K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC · 2022
  • K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
  • K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC · 2017
  • K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC · 2013

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/K160522 · printed Nov 6, 2026

Cite this page

510(k) Report. “K160522: White Pearl Preferred Angle Anterior Cervical Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160522

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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