510(k) · Cleared
ClearedReliance Posterior Cervical- Thoracic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reliance Medical Systems, LLC · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Oct 24, 2012 as substantially equivalent to K003780 (Medtronic Sofamor Danek, Inc., 2001) and 3 other predicates after an 85-day review. Its family tree reaches back 10 generations to 1985. 4 later devices descend from it.
- Decided
- Oct 24, 2012
- Review
- 85 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K853033 (1985). 22 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 6 generations between
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK083073 Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC · 2009
- This deviceK122292 Reliance Posterior Cervical- Thoracic SystemReliance Medical Systems, LLC · 2012
- Descendant · cites it directly · 3 of its ownK142867 Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
- Descendant · cites it directly · 2 of its ownK213394 Vy Spine™ VySpan™ PCT SystemVy Spine, LLC · 2021
- Descendant · 2 generations on · 1 of its ownK223852 VySpan™ PCT SystemVy Spine, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK232167 VySpan™ PCT SystemVy Spine, LLC · 2023
Show all 10 generations
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 9 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 8 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 7 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 6 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 5 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 4 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK083073 Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC · 2009
- This deviceK122292 Reliance Posterior Cervical- Thoracic SystemReliance Medical Systems, LLC · 2012
Most influential descendants
Showing 4 of 4 · See all- K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015 · cites it directly3descendants
- K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC · 2021 · cites it directly2descendants
- K223852VySpan™ PCT SystemVy Spine, LLC · 2023 · 2 generations on1descendant
- K232167VySpan™ PCT SystemVy Spine, LLC · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −9 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −8 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −7 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −6 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −5 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −4 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −3 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −1 | K083073 | Theken Atoll Cervico-Thoracic System | Theken Spine, LLC | 2009 | — |
| 0 (this device) | K122292 | Reliance Posterior Cervical- Thoracic System | Reliance Medical Systems, LLC | 2012 | — |
| +1 | K142867 | Reliance Posterior Cervical-Thoracic System | Reliance Medical Systems, LLC | 2015 | — |
| +1 | K213394 | Vy Spine™ VySpan™ PCT System | Vy Spine, LLC | 2021 | — |
| +2 | K223852 | VySpan™ PCT System | Vy Spine, LLC | 2023 | — |
| +3 | K232167 | VySpan™ PCT System | Vy Spine, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 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? (4)
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 |
|---|---|---|---|
| * | K003780 | Vertex Reconstruction SystemSummary page 1…MNI Substantial Equivalence The Reliance Posterior Cervical-Thoracic System is substantially eqjuivalent to the legally marketed Medtronic Vertex Reconstruction System (K003780), Pioneer Surgical Posterior Cervical Thoracic System (K092295), the Theken Atoll Cervico-Thoracic System (K083073), and the Alph… | 2001 |
| * | K092295 | Pioneer Posterior Cervico-Thoracic SystemSummary page 1…oracic System is substantially eqjuivalent to the legally marketed Medtronic Vertex Reconstruction System (K003780), Pioneer Surgical Posterior Cervical Thoracic System (K092295), the Theken Atoll Cervico-Thoracic System (K083073), and the Alphatec Solanas Posterior Stabilization System (K05220 1). The Rel… | 2010 |
| * | K083073 | Theken Atoll Cervico-Thoracic SystemSummary page 1…gally marketed Medtronic Vertex Reconstruction System (K003780), Pioneer Surgical Posterior Cervical Thoracic System (K092295), the Theken Atoll Cervico-Thoracic System (K083073), and the Alphatec Solanas Posterior Stabilization System (K05220 1). The Reliance Posterior Cervical-Thoracic System is equivale… | 2009 |
| * | K052201 | Solanas Posterior Stabilization SystemSummary page 1…oneer Surgical Posterior Cervical Thoracic System (K092295), the Theken Atoll Cervico-Thoracic System (K083073), and the Alphatec Solanas Posterior Stabilization System (K05220 1). The Reliance Posterior Cervical-Thoracic System is equivalent to these commercially available devices in terms of material, int… | 2005 |
What descends from it? (4)
2 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 27 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K142867 (Reliance Medical Systems, LLC, 2015) has gone furthest, with 3 descendants of its own.
- 20 other devices also cite its predicate K003780.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Reliance Posterior Cervical-Thoracic System is intended to promote fusion of the cervical spine and cervicothoracic junction (C I-T3), and is indicated for the following: * ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) * spondylolisthesis * spinal stenosis * fracture/dislocation * revision of previous cervical spine surgery *tumors The use of the mini polyaxial screws is…
Read the full statement (165 words)
The Reliance Posterior Cervical-Thoracic System is intended to promote fusion of the cervical spine and cervicothoracic junction (C I-T3), and is indicated for the following:
* ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
* spondylolisthesis
* spinal stenosis
* fracture/dislocation
* revision of previous cervical spine surgery
*tumors
The use of the mini polyaxial screws is limited to placement in the upper thoracic spine JTI - T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dis location or trauma in the cervical/upper thoracic (C]-T3) spine.
WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine. Pedicle screws are intended for placement only in TI-T3 as a means of anchoring the system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122292: Reliance Posterior Cervical- 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/K122292
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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