510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Appliance, Fixation, Spinal Intervertebral Body

K102820510(k) TraditionalCleared Nov 5, 201038-day reviewClass II21 CFR 888.3060Recalls 2

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

Alphatec Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Nov 5, 2010 as substantially equivalent to K070681 (Alphatec Spine, Inc., 2007) and 2 other predicates after a 38-day review. Its family tree reaches back 4 generations to 1998. 38 later devices descend from it. It has been recalled 2 times.

Decided
Nov 5, 2010
Review
38 days
Class
Class II
Product code
KWQ
Recalls
2
Predicates
3

Its longest line of descent runs back 4 generations to K973854 (1998). 14 ancestors in all, the oldest K792352 (1979). 38 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2001: 1 other ancestor2004: 2 other ancestors2000: 1 other ancestor1995: 1 other ancestor2002: 1 other ancestor1997: 1 other ancestor1980: 1 other ancestor1979: 1 other ancestor2011: 2 descendants cleared2020: 3 descendants cleared2015: 1 descendant cleared2017: 2 descendants cleared2014: 1 descendant cleared2013: 1 descendant cleared2023: 5 descendants cleared2019: 2 descendants cleared2021: 2 descendants cleared2024: 6 descendants cleared2025: 9 descendants cleared2022: 1 descendant cleared2026: 3 descendants clearedK973854 · Orion Anterior Cervical Plate System · Sofamor Danek USA,Inc. · 1998×2: 2 generations cleared close together, K042235 (2004), K042922 (2004) K061274 · Venture Anterior Cervical Plate System · Medtronic Sofamor Danek · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 2 other ancestors4 generations back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 7 descendants3 generations forward: 8 descendants4 generations forward: 10 descendants5 generations forward: 7 descendants6 generations forward: 1 descendant K061274 · Venture Anterior Cervical Plate System · Medtronic Sofamor Danek · 2006K042922 · Venture Anterior Cervical Plating System · Medtronic Sofamor Danek, Inc. · 2004K042235 · Orion Anterior Cervical Plating System · Medtronic Sofamor Danek · 2004K973854 · Orion Anterior Cervical Plate System · Sofamor Danek USA,Inc. · 19980+5
  1. Root · 4 generations backK973854 Orion Anterior Cervical Plate SystemSofamor Danek USA,Inc. · 1998
  2. 3 generations backK042235 Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek · 2004
  3. 2 generations backK042922 Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc. · 2004
  4. 1 generation backK061274 Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2006
  5. This deviceK102820 Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc. · 2010
  6. Descendant · cites it directly · 18 of its ownK163104 Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017
  7. Descendant · 2 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
  8. Descendant · 3 generations on · 9 of its ownK203065 Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021
  9. Descendant · cites it directly · 7 of its ownK200995 Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc. · 2020 · Recalled
  10. Descendant · 2 generations on · 6 of its ownK213443 Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc. · 2021

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2011: 22013: 12014: 12015: 12017: 22019: 22020: 32021: 22022: 12023: 52024: 62025: 92026: 3
2011high 9 (2025) · low 0 (2012)2026

Most influential descendants

Showing 5 of 38 · See all
  • K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017 · cites it directly18descendants
  • K190016Lateral Plate SystemCorelink, LLC · 2019 · 2 generations on15descendants
  • K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021 · 3 generations on9descendants
  • K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc. · 2020 · cites it directly7descendants
  • K213443Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc. · 2021 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K973854Orion Anterior Cervical Plate SystemSofamor Danek USA,Inc.1998—
−3K042235Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek2004—
−2K042922Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc.2004—
−1K061274Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek2006—
0 (this device)K102820Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc.2010—
+1K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC2017—
+2K190016Lateral Plate SystemCorelink, LLC2019—
+3K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.2021—
+1K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.202029
+2K213443Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
199510
199710
200010
200110
200210
200420
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201310
201410
201510
201720
201920
202030
202120
202210
202350
202460
202590
202630
FIG. 1 — Lineage of K102820, 1998–2026Source: 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
*K070681Next Generation Anterior Cervical Plating System
Summary page 2
…y/Model Name Manufacturer 510(k) f Next Generation (Trestle) Anterior Cervical Plating System Alphatec Spine, Inc K070681 Slim-Loc System Codman & Shurtleff, Inc K013877 Venture Anterior Cervical Pla…
Alphatec Spine, Inc.20071
*K013877Codman Slim-Loc System
Summary page 2
…le) Anterior Cervical Plating System Alphatec Spine, Inc K070681 Slim-Loc System Codman & Shurtleff, Inc K013877 Venture Anterior Cervical Plate System Medtronic, Inc K061274 Technological Characteristi…
Codman & Shurtleff, Inc.2001—
*K061274Venture Anterior Cervical Plate System
Summary page 2
…Codman & Shurtleff, Inc K013877 Venture Anterior Cervical Plate System Medtronic, Inc K061274 Technological Characteristics Comparison: The Trestle Luxe Anterior Cervical Plating System is substantially equivalent to the…
Medtronic Sofamor Danek2006—

Also cleared against K070681: 1 other device →

What descends from it? (38)

See all 38

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718
K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.20207
K103137Venus Anterior Cervical PlateVerticor, Ltd.20115
K152193Renovis Anterior Cervical Plate SystemRenovis Surgical Technologies, Inc.20154
K111132Genesys Spine Anterior Cervical Plate SystemGenesys Spine20114

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 10, 2015Class IIZ-1547-2015Employee errorDuring a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been both laser marked and labeled as a 14mm Trestle Luxe Screw (4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm). As a result the firm…
May 29, 2012Class IIZ-2273-2012Device DesignOn May 9th 2012 Alphatec Spine received a complaint which reported that the distal tip of the Trestle Luxe Slide Alignment Tool (Part Number 71721), does not properly fit into the hexalobe screw on the Trestle Luxe Plate.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
  • 2 of the 14 ancestors have a recall of any class.
  • Of its descendants, K163104 (Corelink, LLC, 2017) has gone furthest, with 18 descendants of its own.
  • 1 other device also cites its predicate K070681.

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. 2010, 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?

It is intended that this device, in any system configuration, be removed after the development of solid fusion mass of spinal segments in skeletally mature patients. The Trestle Luxe Anterior Cervical Plate System is intended for use in anterior cervical decompression and fusion (ACDF) surgery (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following…

Read the full statement (114 words)

It is intended that this device, in any system configuration, be removed after the development of solid fusion mass of spinal segments in skeletally mature patients.

The Trestle Luxe Anterior Cervical Plate System is intended for use in anterior cervical decompression and fusion (ACDF) surgery (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions:

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

* spondylolisthesis

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

* spinal stenosis

* pseudoarthrosis

* tumor

* and failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K070681

1 other device cites the same predicate.

  • K112533Zavation Cervical Plate SystemZavation, LLC · 2011

More from Alphatec Spine, Inc.

96 FDA decisions under this applicant name. See the company

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc. · 2026
  • K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc. · 2026
  • K253615Invictus Bands SystemAlphatec Spine, Inc. · 2026
  • K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)Alphatec Spine, Inc. · 2026

Recent decisions in KWQ

The KWQ category page

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  • 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/K102820 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102820: Appliance, Fixation, Spinal Intervertebral Body.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102820

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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