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 · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Mar 13, 2009 as substantially equivalent to K070638 (Theken Spine, LLC, 2007) and 2 other predicates after a 149-day review. Its family tree reaches back 9 generations to 1985. 8 later devices descend from it.
- Decided
- Mar 13, 2009
- Review
- 149 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K853033 (1985). 18 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 5 generations between
- 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- This deviceK083073 Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC · 2009
- Descendant · cites it directly · 4 of its ownK122292 Reliance Posterior Cervical- Thoracic SystemReliance Medical Systems, LLC · 2012
- Descendant · 2 generations on · 3 of its ownK142867 Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
- Descendant · 2 generations on · 2 of its ownK213394 Vy Spine™ VySpan™ PCT SystemVy Spine, LLC · 2021
- Descendant · 3 generations on · 1 of its ownK223852 VySpan™ PCT SystemVy Spine, LLC · 2023
- Descendant · cites it directly · 1 of its ownK120998 Solstice Cross ConnectorLife Spine · 2012
Show all 9 generations
- Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 8 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 7 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 6 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 5 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 4 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- This deviceK083073 Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC · 2009
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K122292Reliance Posterior Cervical- Thoracic SystemReliance Medical Systems, LLC · 2012 · cites it directly4descendants
- K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015 · 2 generations on3descendants
- K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC · 2021 · 2 generations on2descendants
- K223852VySpan™ PCT SystemVy Spine, LLC · 2023 · 3 generations on1descendant
- K120998Solstice Cross ConnectorLife Spine · 2012 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −8 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −7 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −6 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −5 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −4 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −3 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −2 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −1 | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| 0 (this device) | K083073 | Theken Atoll Cervico-Thoracic System | Theken Spine, LLC | 2009 | — |
| +1 | K122292 | Reliance Posterior Cervical- Thoracic System | Reliance Medical Systems, LLC | 2012 | — |
| +2 | K142867 | Reliance Posterior Cervical-Thoracic System | Reliance Medical Systems, LLC | 2015 | — |
| +2 | K213394 | Vy Spine™ VySpan™ PCT System | Vy Spine, LLC | 2021 | — |
| +3 | K223852 | VySpan™ PCT System | Vy Spine, LLC | 2023 | — |
| +1 | K120998 | Solstice Cross Connector | Life Spine | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 MNI? 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 |
|---|---|---|---|
| * | K070638 | Theken Atoll Cervico-Thoracic SystemSummary page 1…is MNI 888.3070(b) (1) - Pedicle Screw Spinal System Predicate Devices: Theken - Atoll Cervico-Thoracic System (K070638, K080790) Comparable Device: DePuy Spine (USA) - Mountaineer OCT Spinal System (K080828) Material Composition:… | 2007 |
| * | K080790 | Modification to Theken Atoll Cervico-Thoracic SystemSummary page 1…MNI 888.3070(b) (1) - Pedicle Screw Spinal System Predicate Devices: Theken - Atoll Cervico-Thoracic System (K070638, K080790) Comparable Device: DePuy Spine (USA) - Mountaineer OCT Spinal System (K080828) Material Composition:… | 2008 |
| * | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal SystemSummary page 2…ing predicate devices: 1. Atoll Cervico-Thoracic System (K070638, K080790) manufactured by Theken Spine. 2. Mountaineer OCT Spinal System (K042508) manufactured by DePuy Spine. Equivalence for the Atoll Cervico-Thoracic System is based on similarities of intended use, des… | 2004 |
What descends from it? (8)
3 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 24 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K122292 (Reliance Medical Systems, LLC, 2012) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K070638.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 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 (Cl - 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 · Revision of previous cervical and upper…
Read the full statement (151 words)
The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (Cl - 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
· 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 (C I-T3) spine.
The Atoll Cervico-Thoracic System can also be linked to the Theken Coral Spinal System with the use of
transitional rods and rod connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083073 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083073: 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/K083073
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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