510(k) · Cleared
ClearedTether Acfs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theken Surgical,Llc · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 16, 2001 as substantially equivalent to K970048 (Synthes (Usa), 1997) after an 89-day review. Its family tree reaches back 2 generations to 1993. 43 later devices descend from it.
- Decided
- May 16, 2001
- Review
- 89 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K926453 (1993). 4 ancestors in all. 43 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
- 1 generation backK970048 Synthes (Usa)Titanium Locking Plate System (Tilps)Synthes (Usa) · 1997
- This deviceK010466 Tether AcfsTheken Surgical,Llc · 2001
- Descendant · cites it directly · 21 of its ownK121514 Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012
- Descendant · 2 generations on · 18 of its ownK163104 Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017
- Descendant · 3 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
- Descendant · cites it directly · 12 of its ownK040003 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004
- Descendant · 2 generations on · 11 of its ownK043181 Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012 · cites it directly21descendants
- K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017 · 2 generations on18descendants
- K190016Lateral Plate SystemCorelink, LLC · 2019 · 3 generations on15descendants
- K040003Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004 · cites it directly12descendants
- K043181Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae Plate | Synthes (Usa) | 1993 | — |
| −1 | K970048 | Synthes (Usa)Titanium Locking Plate System (Tilps) | Synthes (Usa) | 1997 | — |
| 0 (this device) | K010466 | Tether Acfs | Theken Surgical,Llc | 2001 | — |
| +1 | K121514 | Anodyne Anterior Cervical Plate System | Corelink, LLC | 2012 | — |
| +2 | K163104 | Terrace™ Anterior Cervical Plate System | Corelink, LLC | 2017 | — |
| +3 | K190016 | Lateral Plate System | Corelink, LLC | 2019 | — |
| +1 | K040003 | Vertebron SCP Cervical Plate System | Vertebron, Inc. | 2004 | — |
| +2 | K043181 | Modification to Vertebron SCP Cervical Plate System | Vertebron, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 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? (1)
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 |
|---|---|---|---|
| * | K970048 | Synthes (Usa)Titanium Locking Plate System (Tilps)Summary page 1…to C7 during the time interval required for arthrodesis. Substantial Equivalence: Synthes (USA) Titanium Locking Plate System (TILPS) (K970048) ftawý. G4 DEPARTMENTOF HEALTH& HUMAN SERVICES… | 1997 |
What descends from it? (43)
See all 436 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121514 | Anodyne Anterior Cervical Plate System | 2012 | 21 |
| K040003 | Vertebron SCP Cervical Plate System | 2004 | 12 |
| K112809 | Blue Mountain Cervical Plate | 2012 | 2 |
| K170342 | Ocata Anterior Cervical System | 2017 | 1 |
| K071990 | Valeo Cervical Plate System | 2007 | 1 |
| K080690 | Manta Ray Anterior Cervical Plate System | 2008 | 0 |
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 8 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K121514 (Corelink, LLC, 2012) has gone furthest, with 21 descendants of its own.
- 6 other devices also cite its predicate K970048.
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.
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 Tether T""ACFS is indicated for trauma, deformity (lordosis, kyphosis and
scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor,
degenerative disk disease (DDD is defined as back pain of discogenic origin with
degeneration of the disc confirmed by history and radiographic studies.),
spondylolisthesis; and spinal stenosis.
The Tether T"°ACFS is indicated for temporary stabilization of the spine from C2 to
C7 during the time interval required for arthrodesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K010466 · printed Nov 5, 2026
Cite this page
510(k) Report. “K010466: Tether Acfs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K010466
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026