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 Apr 29, 2015 as substantially equivalent to K122292 (Reliance Medical Systems, LLC, 2012) and 1 other predicate after a 210-day review. Its family tree reaches back 13 generations to 1985. 3 later devices descend from it.
- Decided
- Apr 29, 2015
- Review
- 210 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K853033 (1985). 46 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 9 generations between
- 3 generations backK080526 Sierra SystemSeaspine, Inc. · 2008
- 2 generations backK133698 Synapse SystemSynthes USA Products, LLC · 2014
- 1 generation backK141897 Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC · 2014
- This deviceK142867 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 13 generations
- Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 12 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 11 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 10 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 9 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 8 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 7 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 6 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 5 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 4 generations backK062934 SierraSeaspine, Inc. · 2006
- 3 generations backK080526 Sierra SystemSeaspine, Inc. · 2008
- 2 generations backK133698 Synapse SystemSynthes USA Products, LLC · 2014
- 1 generation backK141897 Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC · 2014
- This deviceK142867 Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −12 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −11 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −10 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −9 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −8 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −7 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −6 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −5 | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −4 | K062934 | Sierra | Seaspine, Inc. | 2006 | — |
| −3 | K080526 | Sierra System | Seaspine, Inc. | 2008 | — |
| −2 | K133698 | Synapse System | Synthes USA Products, LLC | 2014 | — |
| −1 | K141897 | Synapse System, Synthes OC Fusion System | Synthes USA Products, LLC | 2014 | — |
| 0 (this device) | 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 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K122292 | Reliance Posterior Cervical- Thoracic SystemSummary page 4…88.3050) Product Code: KWP Substantial Equivalence The Reliance Posterior Cervical-Thoracic System is substantially equivalent to itself (K122292), primary predicate device and the secondary predicate device, Synthes Synapse System & OC Fusion System (K141897), in terms of m… | 2012 |
| * | K141897 | Synapse System, Synthes OC Fusion SystemSummary page 4…-Thoracic System is substantially equivalent to itself (K122292), primary predicate device and the secondary predicate device, Synthes Synapse System & OC Fusion System (K141897), in terms of material, intended use, levels of attachment, size range, and strength. Device Description The Reliance Posterior C… | 2014 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213394 | Vy Spine™ VySpan™ PCT System | 2021 | 2 |
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 30 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 46 ancestors have a recall of any class.
- Of its descendants, K213394 (Vy Spine, LLC, 2021) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K122292.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 (C1-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 polyaxial screws is limited to…
Read the full statement (155 words)
The Reliance Posterior Cervical-Thoracic System is intended to promote fusion of the cervical spine and cervicothoracic junction (C1-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 polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the system 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/dislocation or trauma in the cervical/upper thoracic (C1-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 T1-T3 as a means of anchoring the system.
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/K142867 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142867: Reliance Posterior Cervical-Thoracic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142867
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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