510(k) · Cleared
ClearedTheken Atoll Cervico-Thoracic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theken Spine, LLC · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on May 30, 2007 as substantially equivalent to K990965 (Synthes (Usa), 1999) and 2 other predicates after an 84-day review. Its family tree reaches back 4 generations to 1985. 59 later devices descend from it.
- Decided
- May 30, 2007
- Review
- 84 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K853033 (1985). 10 ancestors in all. 59 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 3 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 2 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 1 generation backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- This deviceK070638 Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC · 2007
- Descendant · cites it directly · 24 of its ownK092295 Pioneer Posterior Cervico-Thoracic SystemPioneer Surgical Technology · 2010
- Descendant · cites it directly · 21 of its ownK083863 Theken Atoll Oct Spinal SystemTheken Spine, LLC · 2009
- Descendant · 2 generations on · 18 of its ownK112757 Pioneer Posterior Cervico Thoracic SystemPioneer Surgical Technology, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 17 of its ownK121725 Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc. · 2012
- Descendant · 2 generations on · 13 of its ownK141222 Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K092295Pioneer Posterior Cervico-Thoracic SystemPioneer Surgical Technology · 2010 · cites it directly24descendants
- K083863Theken Atoll Oct Spinal SystemTheken Spine, LLC · 2009 · cites it directly21descendants
- K112757Pioneer Posterior Cervico Thoracic SystemPioneer Surgical Technology, Inc. · 2012 · 2 generations on18descendants
- K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc. · 2012 · 3 generations on17descendants
- K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −3 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −2 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −1 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| 0 (this device) | K070638 | Theken Atoll Cervico-Thoracic System | Theken Spine, LLC | 2007 | — |
| +1 | K092295 | Pioneer Posterior Cervico-Thoracic System | Pioneer Surgical Technology | 2010 | — |
| +1 | K083863 | Theken Atoll Oct Spinal System | Theken Spine, LLC | 2009 | — |
| +2 | K112757 | Pioneer Posterior Cervico Thoracic System | Pioneer Surgical Technology, Inc. | 2012 | 1 |
| +3 | K121725 | Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System | Pioneer Surgical Technology, Inc. | 2012 | — |
| +2 | K141222 | Nautilus Spinal System and Solstice Oct System | Life Spine, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 7 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 10 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990965 | Synthes Cervifix SystemSummary page 1…ixation Orthosis MNI 888.3070(b)(1) - Pedicle Screw Spinal System Predicate Device: Synthes (USA) - Cervifix System (K990965)fStarlock System Medtronic Sofamor Danek USA, Inc. - VERTEX… | 1999 |
| * | K003780 | Vertex Reconstruction SystemSummary page 1…System Medtronic Sofamor Danek USA, Inc. - VERTEX Reconstruction System (K003780) DePuy-AcroMed, Inc.-Summit Occipito-Crevico-Thoracic (OCT)… | 2001 |
| * | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemSummary page 1…truction System (K003780) DePuy-AcroMed, Inc.-Summit Occipito-Crevico-Thoracic (OCT) Spinal System (K002733) Material Composition: Implant Grade Titanium Alloy (Ti-6AI-4V) per ASTM F136 and… | 2000 |
What descends from it? (59)
See all 596 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092295 | Pioneer Posterior Cervico-Thoracic System | 2010 | 24 |
| K083863 | Theken Atoll Oct Spinal System | 2009 | 21 |
| K080790 | Modification to Theken Atoll Cervico-Thoracic System | 2008 | 9 |
| K083073 | Theken Atoll Cervico-Thoracic System | 2009 | 8 |
| K182508 | Saxxony™ Posterior Cervical Thoracic System | 2018 | 4 |
| K133214 | Blackbird Spinal System | 2014 | 3 |
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 6.5 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K092295 (Pioneer Surgical Technology, 2010) has gone furthest, with 24 descendants of its own.
- 2 other devices also cite its predicate K990965.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1-T3). The intended indications are as follows: degenerative disc disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; tumors; pseudoarthrosis; and revision of previous cervical and upper thoracic…
Read the full statement (119 words)
The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1-T3). The intended indications are as follows: degenerative disc disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; tumors; pseudoarthrosis; and revision of previous cervical and upper thoracic spine surgery.
The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K070638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070638: Theken Atoll Cervico-Thoracic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070638
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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