510(k) · Cleared
ClearedPioneer Posterior Cervico-Thoracic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Feb 19, 2010 as substantially equivalent to K070638 (Theken Spine, LLC, 2007) and 4 other predicates after a 205-day review. Its family tree reaches back 5 generations to 1985. 24 later devices descend from it.
- Decided
- Feb 19, 2010
- Review
- 205 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K853033 (1985). 12 ancestors in all. 24 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 4 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 3 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 2 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 1 generation backK070638 Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC · 2007
- This deviceK092295 Pioneer Posterior Cervico-Thoracic SystemPioneer Surgical Technology · 2010
- Descendant · cites it directly · 18 of its ownK112757 Pioneer Posterior Cervico Thoracic SystemPioneer Surgical Technology, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 17 of its ownK121725 Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc. · 2012
- Descendant · 3 generations on · 8 of its ownK171369 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2017
- Descendant · 4 generations on · 6 of its ownK200130 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020
- Descendant · cites it directly · 4 of its ownK122292 Reliance Posterior Cervical- Thoracic SystemReliance Medical Systems, LLC · 2012
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K112757Pioneer Posterior Cervico Thoracic SystemPioneer Surgical Technology, Inc. · 2012 · cites it directly18descendants
- K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc. · 2012 · 2 generations on17descendants
- K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2017 · 3 generations on8descendants
- K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020 · 4 generations on6descendants
- K122292Reliance Posterior Cervical- Thoracic SystemReliance Medical Systems, LLC · 2012 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −4 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −3 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −2 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −1 | K070638 | Theken Atoll Cervico-Thoracic System | Theken Spine, LLC | 2007 | — |
| 0 (this device) | K092295 | Pioneer Posterior Cervico-Thoracic System | Pioneer Surgical Technology | 2010 | — |
| +1 | K112757 | Pioneer Posterior Cervico Thoracic System | Pioneer Surgical Technology, Inc. | 2012 | 1 |
| +2 | K121725 | Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System | Pioneer Surgical Technology, Inc. | 2012 | — |
| +3 | K171369 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | 2017 | — |
| +4 | K200130 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | 2020 | — |
| +1 | K122292 | Reliance Posterior Cervical- Thoracic System | Reliance Medical Systems, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 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? (5)
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 2…neer Posterior Cervico-Thoracic System Determination: are similar to the following predicate devices: 1. Atoll Cervico-Thoracic System (K07063 8), Theken Spine, SE date 05/30/2007. 2. Summit OCT Spinal System (K002733), DePuy… | 2007 |
| * | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemSummary page 2…1. Atoll Cervico-Thoracic System (K07063 8), Theken Spine, SE date 05/30/2007. 2. Summit OCT Spinal System (K002733), DePuy AcroMed, Inc., SE date 12/15/2000. 3. VERTEXTm Reconstruction System (K00… | 2000 |
| * | K003780 | Vertex Reconstruction SystemSummary page 2…2. Summit OCT Spinal System (K002733), DePuy AcroMed, Inc., SE date 12/15/2000. 3. VERTEXTm Reconstruction System (K003780), Medtronic Sofamor Danek USA, Inc., SE date 09/28/2001. 4. Spine Oasys System (K… | 2001 |
| * | K032394 | Stryker Spine Oasys SystemSummary page 2…. VERTEXTm Reconstruction System (K003780), Medtronic Sofamor Danek USA, Inc., SE date 09/28/2001. 4. Spine Oasys System (K032394), Stryker, SE date 2/20/2004 5. Cervifix/ Starlock System (K990965) Synthes (USA), SE date… | 2004 |
| * | K990965 | Synthes Cervifix SystemSummary page 2…USA, Inc., SE date 09/28/2001. 4. Spine Oasys System (K032394), Stryker, SE date 2/20/2004 5. Cervifix/ Starlock System (K990965) Synthes (USA), SE date 7/1/1999. Equivalence for Pioneer Posterior Cervico-Thora… | 1999 |
What descends from it? (24)
See all 242 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 25 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K112757 (Pioneer Surgical Technology, Inc., 2012) has gone furthest, with 18 descendants of its own.
- 5 other devices also cite its predicate K070638.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Pioneer Posterior 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 defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - Spondylolisthesis - Spinal Stenosis - Fracture! Dislocation - Deformities or Curvature - Tumors - Pseudoarthrosis - Revision…
Read the full statement (134 words)
The Pioneer Posterior 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 defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis
- Spinal Stenosis
- Fracture! Dislocation
- Deformities or Curvature
- 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 (Tl-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 (Cl-T3) spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092295: Pioneer Posterior 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/K092295
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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