510(k) · Cleared

Recalled · 2004

U & I America Spinal Hook System

K031595510(k) TraditionalCleared Jun 24, 200334-day reviewClass II21 CFR 888.3050Recalls 3

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

U&I Corp., America · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Jun 24, 2003 as substantially equivalent to K983904 (United States Surgical, A Division of Tyco Healthc, 1998) and 2 other predicates after a 34-day review. Its family tree reaches back 2 generations to 1988. 14 later devices descend from it. It has been recalled 3 times.

Decided: Jun 24, 2003
Review: 34 days
Class: Class II
Product code: KWP
Recalls: 3
Predicates: 3

Its longest line of descent runs back 2 generations to K884263 (1988). 8 ancestors in all. 14 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK884263 Rogozinski Spinal SystemRichards Medical Co., Inc. · 1988
1 generation backK983904 Rogozinski Spinal Rod SystemUnited States Surgical, A Division of Tyco Healthc · 1998
This deviceK031595 U & I America Spinal Hook SystemU&I Corp., America · 2003
Descendant · cites it directly · 6 of its ownK113324 Rexious Hook Fixation SystemsDio Medical Co., Ltd. · 2012
Descendant · cites it directly · 5 of its ownK123476 Mega 5.5 Spine SystemLsk Biopartners, Inc. · 2013
Descendant · 2 generations on · 4 of its ownK171497 Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
Descendant · 3 generations on · 3 of its ownK241657 MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti. · 2024
Descendant · 2 generations on · 2 of its ownK132365 Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine · 2013 · Recalled

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2011high 3 (2013) · low 0 (2015)2026

Most influential descendants

Showing 5 of 14 · See all

K113324Rexious Hook Fixation SystemsDio Medical Co., Ltd. · 2012 · cites it directly6descendants
K123476Mega 5.5 Spine SystemLsk Biopartners, Inc. · 2013 · cites it directly5descendants
K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017 · 2 generations on4descendants
K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti. · 2024 · 3 generations on3descendants
K132365Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine · 2013 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K884263	Rogozinski Spinal System	Richards Medical Co., Inc.	1988	—
−1	K983904	Rogozinski Spinal Rod System	United States Surgical, A Division of Tyco Healthc	1998	—
0 (this device)	K031595	U & I America Spinal Hook System	U&I Corp., America	2003	—
+1	K113324	Rexious Hook Fixation Systems	Dio Medical Co., Ltd.	2012	—
+1	K123476	Mega 5.5 Spine System	Lsk Biopartners, Inc.	2013	—
+2	K171497	Mikron Spinal Fixation System	Mikron Makina Sanayi Ticaret Co., Ltd.	2017	—
+3	K241657	MSFX Mikron Spinal Fixation System	Mikron Makina Sanayi VE Ticaret Ltd. Sti.	2024	—
+2	K132365	Spondylolisthesis Spinal Fixation, Spinal Pedicle Fixation	Accel Spine	2013	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1995	2	0
1996	1	0
1997	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	1	0
2013	3	0
2014	1	0
2017	1	0
2018	1	0
2022	1	0
2023	1	0
2024	1	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K031595, 1988–2026Source: 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

Get a 510(k) Report

What was it cleared against? (3)

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
*	K983904	Rogozinski Spinal Rod System Our reading of the summary gave K983804, FDA’s number for The Aptus (Automated) Application of the Ebv-EA Igg Elisa… (Zeus Scientific, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “United States Surgical Corporation, Rogozinski Spinal System”.	United States Surgical, A Division of Tyco Healthc	1998	—
*	K001319	Xia Spine System Hooks Summary page 1 …orporation, Rogozinski Spinal System - KWP, MNH, MNI, KWQ -- (K983804) Cotrel-Dubousset (CD'") Spinal system -- MNH, MNI, KWQ, KWP -- (K001319, K955807) The substantial equivalence of this device is based on equivalence in intended use…	Howmedica Osteonics Corp.	2000	—
*	K955807	Cotrel-Dubousset (CD) Spinal Summary page 1 …KWP, MNH, MNI, KWQ -- (K983804) Cotrel-Dubousset (CD'") Spinal system -- MNH, MNI, KWQ, KWP -- (K001319, K955807) The substantial equivalence of this device is based on equivalence in intended use, materials, designs and operat…	Sofamor Danek USA,Inc.	1996	—

Also cleared against K983904: 3 other devices →

What descends from it? (14)

See all 14

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K113324	Rexious Hook Fixation Systems	Dio Medical Co., Ltd.	2012	6
K123476	Mega 5.5 Spine System	Lsk Biopartners, Inc.	2013	5
K101374	Aaxter A3 Posterior Spinal System	Aaxter Co., Ltd.	2011	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 10, 2004	Not classified	Z-1438-04	Other	Threads on a set screw, as a component of a spinal fixation system, may break off during use.
Jan 14, 2004	Not classified	Z-0559-04	Other	Reports of hex driver tips breaking off or becoming worn or stripped.
Jan 14, 2004	Not classified	Z-0558-04	Other	Reports of hex driver tips breaking off or becoming worn or stripped.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
None of the 8 ancestors has a recall.
Of its descendants, K113324 (Dio Medical Co., Ltd., 2012) has gone furthest, with 6 descendants of its own.
3 other devices also cite its predicate K983904.

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.

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 U & I Spinal Hook and Rod System intended for use as a posterior, noncervical, nonpedicle system indicated for 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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The U & I Spinal Hook and Rod System can be used in conjunction with the OPTIMA Spinal System or the GLOBAL Spinal Fixation System.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031595 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031595: U & I America Spinal Hook System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031595

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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