510(k) · Cleared
Recalled · Class II · 2012Pioneer Posterior Cervico Thoracic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Mar 12, 2012 as substantially equivalent to K092295 (Pioneer Surgical Technology, 2010) after a 172-day review. Its family tree reaches back 6 generations to 1985. 18 later devices descend from it. It has been recalled once.
- Decided
- Mar 12, 2012
- Review
- 172 days
- Class
- Class II
- Product code
- KWP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K853033 (1985). 13 ancestors in all. 18 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 5 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 4 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 3 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 2 generations backK070638 Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC · 2007
- 1 generation backK092295 Pioneer Posterior Cervico-Thoracic SystemPioneer Surgical Technology · 2010
- This deviceK112757 Pioneer Posterior Cervico Thoracic SystemPioneer Surgical Technology, Inc. · 2012
- Descendant · cites it directly · 17 of its ownK121725 Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc. · 2012
- Descendant · 2 generations on · 8 of its ownK171369 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2017
- Descendant · 3 generations on · 6 of its ownK200130 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020
- Descendant · 4 generations on · 3 of its ownK200936 Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- Descendant · 2 generations on · 3 of its ownK133374 Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I · 2014
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc. · 2012 · cites it directly17descendants
- K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2017 · 2 generations on8descendants
- K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020 · 3 generations on6descendants
- K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 4 generations on3descendants
- K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I · 2014 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −5 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −4 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −3 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −2 | K070638 | Theken Atoll Cervico-Thoracic System | Theken Spine, LLC | 2007 | — |
| −1 | K092295 | Pioneer Posterior Cervico-Thoracic System | Pioneer Surgical Technology | 2010 | — |
| 0 (this device) | K112757 | Pioneer Posterior Cervico Thoracic System | Pioneer Surgical Technology, Inc. | 2012 | — |
| +1 | K121725 | Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System | Pioneer Surgical Technology, Inc. | 2012 | — |
| +2 | K171369 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | 2017 | — |
| +3 | K200130 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | 2020 | — |
| +4 | K200936 | Invictus™ CT Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| +2 | K133374 | Streamline Oct Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Rti Surgical, I | 2014 | — |
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 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2022 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K092295 | Pioneer Posterior Cervico-Thoracic SystemSummary page 2…ns Class I manual surgical instruments and cases that are considered exempt from premarket notification. PREDICATE DEVICES Posterior Cervico-Thoracic System (K092295), Pioneer Surgical Technology, Inc. COMPARISON TO MARKETED DEVICE Equivalency of this device is based on similarities in inte… | 2010 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121725 | Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System | 2012 | 17 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 10, 2012 | Class II | Z-2573-2014 | Nonconforming Material/Component | Some set screw thread profiles were found not to be within specifications. |
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 2.7 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K121725 (Pioneer Surgical Technology, Inc., 2012) has gone furthest, with 17 descendants of its own.
- 1 other device also cites its predicate K092295.
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 Pioneer Posterior Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1-13). 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 (135 words)
The Pioneer Posterior Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1-13). 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 (T I-T3) in treating thoracic conditions only. Thie 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 (CI -T3) spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112757 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112757: Pioneer Posterior Cervico Thoracic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112757
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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