510(k) · Cleared

Cleared

Rogozinski Spinal Rod System

K983904510(k) TraditionalCleared Dec 22, 199849-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

United States Surgical, A Division of Tyco Healthc · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Dec 22, 1998 as substantially equivalent to K884263 (Richards Medical Co., Inc., 1988) and 4 other predicates after a 49-day review. Its family tree reaches back 1 generation to 1988. 27 later devices descend from it.

Decided: Dec 22, 1998
Review: 49 days
Class: Class II
Product code: KWP
Recalls: None
Predicates: 6

Its longest line of descent runs back 1 generation to K884263 (1988). 5 ancestors in all. 27 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK884263 Rogozinski Spinal SystemRichards Medical Co., Inc. · 1988
This deviceK983904 Rogozinski Spinal Rod SystemUnited States Surgical, A Division of Tyco Healthc · 1998
Descendant · cites it directly · 14 of its ownK031595 U & I America Spinal Hook SystemU&I Corp., America · 2003 · Recalled
Descendant · cites it directly · 9 of its ownK100757 Tilock Pedicle Screw SystemGenesys Spine · 2010 · Recalled
Descendant · 2 generations on · 8 of its ownK103671 Genesys Spine Tilock SystemGenesys Spine · 2011
Descendant · 2 generations on · 7 of its ownK152039 Genesys Spine TiLock2 Spinal SystemGenesys Spine · 2015
Descendant · 2 generations on · 6 of its ownK113324 Rexious Hook Fixation SystemsDio Medical Co., Ltd. · 2012

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2003high 4 (2013) · low 0 (2004)2026

Most influential descendants

Showing 5 of 27 · See all

K031595U & I America Spinal Hook SystemU&I Corp., America · 2003 · cites it directly14descendants
K100757Tilock Pedicle Screw SystemGenesys Spine · 2010 · cites it directly9descendants
K103671Genesys Spine Tilock SystemGenesys Spine · 2011 · 2 generations on8descendants
K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine · 2015 · 2 generations on7descendants
K113324Rexious Hook Fixation SystemsDio Medical Co., Ltd. · 2012 · 2 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K884263	Rogozinski Spinal System	Richards Medical Co., Inc.	1988	—
0 (this device)	K983904	Rogozinski Spinal Rod System	United States Surgical, A Division of Tyco Healthc	1998	—
+1	K031595	U & I America Spinal Hook System	U&I Corp., America	2003	3
+1	K100757	Tilock Pedicle Screw System	Genesys Spine	2010	1
+2	K103671	Genesys Spine Tilock System	Genesys Spine	2011	—
+2	K152039	Genesys Spine TiLock2 Spinal System	Genesys Spine	2015	—
+2	K113324	Rexious Hook Fixation Systems	Dio Medical Co., Ltd.	2012	—

Other ancestors by year cleared

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2010	1	0
2011	3	0
2012	1	0
2013	4	0
2014	1	0
2015	1	0
2016	1	0
2017	3	0
2018	1	0
2020	1	0
2022	1	0
2023	1	0
2024	1	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K983904, 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

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What was it cleared against? (6)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K884263	Rogozinski Spinal System Summary page 1 …xation Orthosis Spondylelisthesis Spinal Fixation Device System Spinal Rod System Rogczinski Spinal Rod System USSC's Surgical Dynamics™ Rogozinski Spinal Rod System - K884263, K896106, K930298, K950865, K854696, K965224 The Rogozinski Spinal Rod System consists of stainless steel rods attached to the s…	Richards Medical Co., Inc.	1988	—
*	K896106	Rogozinski Spinal System, Add'l Components Summary page 1 …thosis Spondylelisthesis Spinal Fixation Device System Spinal Rod System Rogczinski Spinal Rod System USSC's Surgical Dynamics™ Rogozinski Spinal Rod System - K884263, K896106, K930298, K950865, K854696, K965224 The Rogozinski Spinal Rod System consists of stainless steel rods attached to the spinal col…	Richards Medical Co., Inc.	1990	—
*	K930298	Rogozinski Spinal Rod System Screw Summary page 1 …ondylelisthesis Spinal Fixation Device System Spinal Rod System Rogczinski Spinal Rod System USSC's Surgical Dynamics™ Rogozinski Spinal Rod System - K884263, K896106, K930298, K950865, K854696, K965224 The Rogozinski Spinal Rod System consists of stainless steel rods attached to the spinal column throu…	Smith & Nephew Richards, Inc.	1995	—
*	K950865	Rogozinski Spinal Rod System Rod-to-Bolt (Universal) Connector for Use with the Simmons… Summary page 1 …thesis Spinal Fixation Device System Spinal Rod System Rogczinski Spinal Rod System USSC's Surgical Dynamics™ Rogozinski Spinal Rod System - K884263, K896106, K930298, K950865, K854696, K965224 The Rogozinski Spinal Rod System consists of stainless steel rods attached to the spinal column through the us…	Smith & Nephew Richards, Inc.	1995	—
Kept off the family tree	K854696	FDA’s K854696 is OP II Visible Light Curing System Our OCR of the scanned summary read K854696, FDA’s number for OP II Visible Light Curing System (Almore Intl., Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “USSC's Surgical Dynamics™ Rogozinski Spinal Rod System”. Kept off the family tree. Summary page 1 …inal Fixation Device System Spinal Rod System Rogczinski Spinal Rod System USSC's Surgical Dynamics™ Rogozinski Spinal Rod System - K884263, K896106, K930298, K950865, K854696, K965224 The Rogozinski Spinal Rod System consists of stainless steel rods attached to the spinal column through the use of inte…	Almore Intl., Inc.	1986	—
*	K965224	Empower Anterior Direct Screws Summary page 1 …tion Device System Spinal Rod System Rogczinski Spinal Rod System USSC's Surgical Dynamics™ Rogozinski Spinal Rod System - K884263, K896106, K930298, K950865, K854696, K965224 The Rogozinski Spinal Rod System consists of stainless steel rods attached to the spinal column through the use of interlaminal…	Smith & Nephew Richards, Inc.	1997	—

Also cleared against K884263: 1 other device →

What descends from it? (27)

See all 27

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

Number	Device	Applicant	Decided	Descendants
K031595	U & I America Spinal Hook System	U&I Corp., America	2003	14
K100757	Tilock Pedicle Screw System	Genesys Spine	2010	9
K132644	Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…	Corentec Co., Ltd.	2013	0
K110046	Athena Pedicle Screw System	Royal Oak Medical Devices	2011	0

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?

None of the 5 ancestors has a recall.
Of its descendants, K031595 (U&I Corp., America, 2003) has gone furthest, with 14 descendants of its own.
1 other device also cites its predicate K884263.

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?

Non-Pedicle Screw Fixation Whan used as an anterior spinal system the Rogozinski Spinal Rod System is intended for the treatement of DDD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, stenosis, deformities (scoliosis, Kyphosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Rogozinski Spinal Red…

Read the full statement (293 words)

Non-Pedicle Screw Fixation

Whan used as an anterior spinal system the Rogozinski Spinal Rod System is intended for the treatement of DDD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, stenosis, deformities (scoliosis, Kyphosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Rogozinski Spinal Red System is limited to non-cervical use.

When used as a posterior, non-pedicle spinal system (consisting of hooks and sacralflliac scraws), the Rogozinski Spinal Rod System is intended for the treatement of ODD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, stenosis, deformities (scoliosis, kyphosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Rogozinski Spinal Rod System is limited to non-cervical use.

Pedicle Screw Fixation

When used as a pedicle screw system, in the spine of skeletally mature patients, the Rogozinski Spinal Rod System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Rogozinski Spinal Rod System is intended to provide immabilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilites of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neuroclogic impairment, fracture, dislocation, scofiosis, kyphosis, spinal tumor, and failed previous fusion (pseudarhrosis).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K983904 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983904: Rogozinski Spinal Rod System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983904

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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