510(k) · Cleared

Cleared

Transcorp Spinal Access System

K113352510(k) TraditionalCleared Apr 16, 2012154-day reviewClass II21 CFR 888.1100

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

Cleared on Apr 16, 2012 as substantially equivalent to K032891 (Trans1, Inc., 2004) after a 154-day review. Its family tree reaches back 1 generation to 2004.

Decided: Apr 16, 2012
Review: 154 days
Class: Class II
Product code: HRX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K032891 (2004). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK032891 TRANS1 Trans-Sacral Spinal Access and Preparation KitTrans1, Inc. · 2004
This deviceK113352 Transcorp Spinal Access SystemTranscorp, Inc. · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K032891	TRANS1 Trans-Sacral Spinal Access and Preparation Kit	Trans1, Inc.	2004	—
0 (this device)	K113352	Transcorp Spinal Access System	Transcorp, Inc.	2012	—

FIG. 1 — Lineage of K113352, 2004–2012Source: 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 HRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HRX device

#1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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
*	K032891	TRANS1 Trans-Sacral Spinal Access and Preparation Kit Summary page 1 …Set Classification: 21 CFR Section 888.1100, Arthroscope Product Code: HRX Substantially Eq~uivalent Device: K032891:- TranS 1 Trans-Sacral Spinal Access and Preparation Device Device Descrintion: The Transcorp Spinal Access S…	Trans1, Inc.	2004	—

Also cleared against K032891: 2 other devices →

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.
2 other devices also cite its predicate K032891.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · HRX

9in 2025

2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007high 249 (2023) · low 45 (2019)2026

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

Recalls per year · HRX

1in 2024

2007high 23 (2009) · low 0 (2012)2026

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

Adverse event reports per year · HRX

2,076in 2025

2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, 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	7	89	3	421
2008	9	115	13	441
2009	11	139	23	558
2010	9	114	12	612
2011	3	84	6	631
2012	11	102	0	778
2013	12	90	4	678
2014	9	140	0	802
2015	4	132	7	763
2016	8	89	0	469
2017	4	97	0	934
2018	12	101	1	1,581
2019	12	45	0	1,676
2020	7	141	0	1,706
2021	7	57	3	1,908
2022	3	89	0	1,406
2023	4	249	0	1,852
2024	6	110	1	2,427
2025	9	107	0	2,076
2026	7	217	0	—

What is it indicated for?

The Transcorp Spinal Access System is indicated for minimally invasive visualization and access to the anterior spine for assisting in various surgical procedures such as herniated disc repair, biopsy, and harvesting autogenous bone.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113352 · printed Nov 5, 2026

Cite this page

510(k) Report. “K113352: Transcorp Spinal Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113352

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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