510(k) · Cleared

Cleared

Pioneer Spinal Process Fusion Plate

K110367510(k) SpecialCleared Mar 23, 201143-day reviewClass II21 CFR 888.3050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pioneer Surgical Technology, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Mar 23, 2011 as substantially equivalent to K101525 (Pioneer Surgical Technology, 2010) after a 43-day review. Its family tree reaches back 1 generation to 2010.

Decided: Mar 23, 2011
Review: 43 days
Class: Class II
Product code: KWP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K101525 (2010). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK101525 Pioneer Spinous Process Fusion PlatePioneer Surgical Technology · 2010
This deviceK110367 Pioneer Spinal Process Fusion PlatePioneer Surgical Technology, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K101525	Pioneer Spinous Process Fusion Plate	Pioneer Surgical Technology	2010	—
0 (this device)	K110367	Pioneer Spinal Process Fusion Plate	Pioneer Surgical Technology, Inc.	2011	—

FIG. 1 — Lineage of K110367, 2010–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K101525	Pioneer Spinous Process Fusion Plate Summary page 1 …rocess Fusion Plate Product Cade/ KWP/ 888.3050 - Spinal Interlaminal Fixation Orthosis Classification: Predicate Device: Pioneer Spinous Process Fusion Plate (K101525, SE date 10/22/2010) Description: The Pioneer Spinous Process Fusion Plate is a plate with spacer system designed to…	Pioneer Surgical Technology	2010	—

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · KWP

9in 2015

2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007high 186 (2010) · low 50 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWP

2in 2022

2007high 23 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWP

494in 2025

2007high 1,379 (2016) · low 210 (2007)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 BacFuse Device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Pioneer BacFuse Device is intended for use with bone graft material (i.e. allograft or autograft), not intended for stand-alone use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110367 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110367: Pioneer Spinal Process Fusion Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110367

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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