510(k) · Cleared
ClearedTerrace™ Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corelink, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jun 21, 2017 as substantially equivalent to K121514 (Corelink, LLC, 2012) and 4 other predicates after a 226-day review. Its family tree reaches back 7 generations to 1992. 18 later devices descend from it.
- Decided
- Jun 21, 2017
- Review
- 226 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K922087 (1992). 66 ancestors in all, the oldest K792352 (1979). 18 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 6 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 5 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 4 generations backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
- 3 generations backK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
- 2 generations backK050892 Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc. · 2005 · Recalled
- 1 generation backK100614 Hallmark Anterior Cervcial Plate System, Hallmark Five-Level…Blackstone Medical, Inc. · 2010
- This deviceK163104 Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017
- Descendant · cites it directly · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
- Descendant · 2 generations on · 9 of its ownK203065 Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK231743 F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody…Corelink, LLC · 2023
- Descendant · 3 generations on · 3 of its ownK223362 Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion…4Web Medical, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK231739 Cervical Spine Truss System (CSTS)4Web Medical, Inc. · 2023
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K190016Lateral Plate SystemCorelink, LLC · 2019 · cites it directly15descendants
- K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021 · 2 generations on9descendants
- K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC · 2023 · 2 generations on3descendants
- K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc. · 2023 · 3 generations on3descendants
- K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc. · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −6 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −5 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −4 | K012184 | Blackstone Iii Anterior Cervical Plating System | Blackstone Medical, Inc. | 2002 | — |
| −3 | K030595 | Blackstone Fusion Anterior Cervical Plating System | Blackstone Medical, Inc. | 2003 | — |
| −2 | K050892 | Hallmarktm Anterior Cervical Plate System | Blackstone Medical, Inc. | 2005 | 2 |
| −1 | K100614 | Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates | Blackstone Medical, Inc. | 2010 | — |
| 0 (this device) | K163104 | Terrace™ Anterior Cervical Plate System | Corelink, LLC | 2017 | — |
| +1 | K190016 | Lateral Plate System | Corelink, LLC | 2019 | — |
| +2 | K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS) | 4Web, Inc. | 2021 | — |
| +2 | K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and… | Corelink, LLC | 2023 | — |
| +3 | K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device | 4Web Medical, Inc. | 2023 | — |
| +3 | K231739 | Cervical Spine Truss System (CSTS) | 4Web Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 9 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2010 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 0 |
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 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K121514 | Anodyne Anterior Cervical Plate SystemSummary page 4…e Devices 510k Trade or Proprietary or Model Manufacturer Predicate Number Name Type K121514 ANODYNE® ACP System CoreLink, LLC Primary K102820 Trestle Luxe ACP Alpha… | 2012 |
| * | K102820 | Appliance, Fixation, Spinal Intervertebral BodySummary page 4…Predicate Number Name Type K121514 ANODYNE® ACP System CoreLink, LLC Primary K102820 Trestle Luxe ACP Alphatec Additional K100614 Anterior Cervical Plating System Or… | 2010 |
| * | K100614 | Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesSummary page 4…Type K121514 ANODYNE® ACP System CoreLink, LLC Primary K102820 Trestle Luxe ACP Alphatec Additional K100614 Anterior Cervical Plating System Orthofix Additional K130202 IRIS™ ACP Li… | 2010 |
| * | K130202 | Iris Anterior Cervical PlateSummary page 4…ry K102820 Trestle Luxe ACP Alphatec Additional K100614 Anterior Cervical Plating System Orthofix Additional K130202 IRIS™ ACP Life Spine Additional K133475 Struxxure Ne… | 2013 |
| * | K133475 | Struxxure Anterior Cervical Plate and ScrewsSummary page 4…al K100614 Anterior Cervical Plating System Orthofix Additional K130202 IRIS™ ACP Life Spine Additional K133475 Struxxure Next Spine Additional… | 2013 |
What descends from it? (18)
See all 183 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 7 of the 66 ancestors have a recall of any class.
- Of its descendants, K190016 (Corelink, LLC, 2019) has gone furthest, with 15 descendants of its own.
- 1 other device also cites its predicate K121514.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The CoreLink TERRACE™ Anterior Cervical Plate System is intended for anterior fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the evolution of cervical fusions in patients with degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions. The intended levels for treatment range from C2 – T1.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163104 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163104: Terrace™ Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163104
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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