510(k) · Cleared
ClearedTransom Anterior Cervical Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurostructures, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Nov 18, 2014 as substantially equivalent to K131374 (Neurostructures, LLC, 2013) and 6 other predicates after a 112-day review. Its family tree reaches back 7 generations to 1992. 19 later devices descend from it.
- Decided
- Nov 18, 2014
- Review
- 112 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 7 generations to K922087 (1992). 28 ancestors in all. 19 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 deviceK142060 Transom Anterior Cervical PlateNeurostructures, Inc. · 2014
- Descendant · cites it directly · 15 of its ownK173521 SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation · 2018
- Descendant · 2 generations on · 14 of its ownK202064 Admiral ACP SystemSeaSpine Orthopedics Corporation · 2020
- Descendant · 2 generations on · 7 of its ownK211903 Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation · 2021
- Descendant · 2 generations on · 6 of its ownK212139 Admiral ACP SystemSeaSpine Orthopedics Corporation · 2021
- Descendant · 3 generations on · 5 of its ownK233640 Segmental Plating System (SPS);IdentiTi SPS Interbody…Alphatec Spine, Inc. · 2024
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation · 2018 · cites it directly15descendants
- K202064Admiral ACP SystemSeaSpine Orthopedics Corporation · 2020 · 2 generations on14descendants
- K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation · 2021 · 2 generations on7descendants
- K212139Admiral ACP SystemSeaSpine Orthopedics Corporation · 2021 · 2 generations on6descendants
- K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc. · 2024 · 3 generations on5descendants
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) | K142060 | Transom Anterior Cervical Plate | Neurostructures, Inc. | 2014 | — |
| +1 | K173521 | SeaSpine Cabo ACP (Anterior Cervical Plate) System | SeaSpine Orthopedics Corporation | 2018 | — |
| +2 | K202064 | Admiral ACP System | SeaSpine Orthopedics Corporation | 2020 | — |
| +2 | K211903 | Shoreline Threaded TruProfile® Plate | SeaSpine Orthopedics Corporation | 2021 | — |
| +2 | K212139 | Admiral ACP System | SeaSpine Orthopedics Corporation | 2021 | — |
| +3 | K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec… | Alphatec Spine, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K131374 | Tempus (TM) Cervical Plate SystemSummary page 4…nd/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. The indications for use for the Transom™ is the same as the Tempus™ Cervical Plate System (K120515, K131374). TECHNOLOGICAL CHARACTERISTICS Transom™ Cervical Plate System is made from titanium alloy that conforms to ASTM F136. Titanium… | 2013 |
| * | K120515 | Tempus Cervical Plate SystemSummary page 4…phosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. The indications for use for the Transom™ is the same as the Tempus™ Cervical Plate System (K120515, K131374). TECHNOLOGICAL CHARACTERISTICS Transom™ Cervical Plate System is made from titanium alloy that conforms to ASTM F136.… | 2012 |
| * | K974885 | Blackstone Medical Inc. Anterior Cervical Plate SystemSummary page 5…ructures, Inc. (Primary Predicate) K120515 Tempus™ Cervical Plate System Neurostructures, Inc. K974885, K012184, Anterior Cervical Plating System Orthofix K030595, K050892, K100614 PERFORMANCE DATA The Tr… | 1998 |
| * | K012184 | Blackstone Iii Anterior Cervical Plating SystemSummary page 5…Inc. (Primary Predicate) K120515 Tempus™ Cervical Plate System Neurostructures, Inc. K974885, K012184, Anterior Cervical Plating System Orthofix K030595, K050892, K100614 PERFORMANCE DATA The Transom™ ha… | 2002 |
| * | K030595 | Blackstone Fusion Anterior Cervical Plating SystemSummary page 5…Tempus™ Cervical Plate System Neurostructures, Inc. K974885, K012184, Anterior Cervical Plating System Orthofix K030595, K050892, K100614 PERFORMANCE DATA The Transom™ has been tested in the following test modes: • Static axial compression… | 2003 |
| * | K050892 | Hallmarktm Anterior Cervical Plate SystemSummary page 5…Tempus™ Cervical Plate System Neurostructures, Inc. K974885, K012184, Anterior Cervical Plating System Orthofix K030595, K050892, K100614 PERFORMANCE DATA The Transom™ has been tested in the following test modes: • Static axial compression bending… | 2005 |
| * | K100614 | Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesSummary page 5…Tempus™ Cervical Plate System Neurostructures, Inc. K974885, K012184, Anterior Cervical Plating System Orthofix K030595, K050892, K100614 PERFORMANCE DATA The Transom™ has been tested in the following test modes: • Static axial compression bending per modif… | 2010 |
What descends from it? (19)
See all 193 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 22 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 28 ancestors have a recall of any class.
- Of its descendants, K173521 (SeaSpine Orthopedics Corporation, 2018) has gone furthest, with 15 descendants of its own.
- 3 other devices also cite its predicate K131374.
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. 2014, 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 Transom™ is intended for anterior cervical fixation (C2-T1) for the following indications: 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142060: Transom 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/K142060
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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