510(k) · Decided

Decided

DSS Stabilization System

K113625510(k) SpecialDecided Jan 10, 201233-day reviewClass II21 CFR 888.3070

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

Paradigm Spine, LLC · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jan 10, 2012 as substantially equivalent to K022949 (Synthes (Usa), 2003) and 7 other predicates after a 33-day review. Its family tree reaches back 7 generations to 1990. 1 later device descends from it.

Decided: Jan 10, 2012
Review: 33 days
Class: Class II
Product code: NKB
Recalls: None
Predicates: 8

Its longest line of descent runs back 7 generations to K901587 (1990). 41 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 7 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
6 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
5 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
4 generations backK080241 DDS Stabilization SystemParadigm Spine, LLC · 2008
3 generations backK090408 Modification to: DSS Stabilization SystemParadigm Spine, LLC · 2009
2 generations backK091944 Modification to: DSS Stabilization SystemParadigm Spine, LLC · 2009
1 generation backK101083 DSS Stabilization SystemParadigm Spine, LLC · 2010
This deviceK113625 DSS Stabilization SystemParadigm Spine, LLC · 2012
Descendant · cites it directly · 0 of its ownK120491 DSS Stabilization System-RigidParadigm Spine, LLC · 2012

Most influential descendants

Showing 1 of 1 · See all

K120491DSS Stabilization System-RigidParadigm Spine, LLC · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K901587	TSRH Sacral L-Connector	Danek Medical, Inc.	1990	—
−6	K950099	Synergy (TM) TI Posterior Spinal System	Buckman Co., Inc.	1997	—
−5	K973836	Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross…	Cross Medical Products, Inc.	1998	—
−4	K080241	DDS Stabilization System	Paradigm Spine, LLC	2008	—
−3	K090408	Modification to: DSS Stabilization System	Paradigm Spine, LLC	2009	—
−2	K091944	Modification to: DSS Stabilization System	Paradigm Spine, LLC	2009	—
−1	K101083	DSS Stabilization System	Paradigm Spine, LLC	2010	—
0 (this device)	K113625	DSS Stabilization System	Paradigm Spine, LLC	2012	—
+1	K120491	DSS Stabilization System-Rigid	Paradigm Spine, LLC	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1992	5	0
1993	2	0
1994	1	0
1995	2	0
1997	1	0
1998	1	0
1999	3	0
2000	4	0
2002	2	0
2003	4	0
2004	2	0
2005	1	0
2007	2	0
2008	2	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

FIG. 1 — Lineage of K113625, 1990–2012Source: 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 NKB? 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 NKB device

#1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (8)

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
*	K022949	Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss Summary page 2 …tal scientific technology of the device. Predicate Device(s): DSSTM Stabilization System - Rigid was shown to be substantially equivalent to previously cleared devices (K022949, K024096, K042962, K072022, K08024 I, K090099, K090408, K090408, and K101083) and has the same indications for use, design, funct…	Synthes (Usa)	2003	—
*	K024096	Optima, Spinal System Summary page 2 …tific technology of the device. Predicate Device(s): DSSTM Stabilization System - Rigid was shown to be substantially equivalent to previously cleared devices (K022949, K024096, K042962, K072022, K08024 I, K090099, K090408, K090408, and K101083) and has the same indications for use, design, function, and…	U&I Corp., America	2003	3
*	K042962	Modification to CD Horizon Spinal System Summary page 2 …hnology of the device. Predicate Device(s): DSSTM Stabilization System - Rigid was shown to be substantially equivalent to previously cleared devices (K022949, K024096, K042962, K072022, K08024 I, K090099, K090408, K090408, and K101083) and has the same indications for use, design, function, and materials…	Medtronic Sofamor Danek	2004	—
*	K072022	Valeo Pedicle Screw Spinal System Summary page 2 …f the device. Predicate Device(s): DSSTM Stabilization System - Rigid was shown to be substantially equivalent to previously cleared devices (K022949, K024096, K042962, K072022, K08024 I, K090099, K090408, K090408, and K101083) and has the same indications for use, design, function, and materials used. S…	Amedica Corp.	2007	—
*	K080241	DDS Stabilization System	Paradigm Spine, LLC	2008	—
*	K090099	DSS Stabilization System Summary page 2 …icate Device(s): DSSTM Stabilization System - Rigid was shown to be substantially equivalent to previously cleared devices (K022949, K024096, K042962, K072022, K08024 I, K090099, K090408, K090408, and K101083) and has the same indications for use, design, function, and materials used. Substantial Equivale…	Paradigm Spine, LLC	2009	—
*	K090408	Modification to: DSS Stabilization System Summary page 2 …ice(s): DSSTM Stabilization System - Rigid was shown to be substantially equivalent to previously cleared devices (K022949, K024096, K042962, K072022, K08024 I, K090099, K090408, K090408, and K101083) and has the same indications for use, design, function, and materials used. Substantial Equivalence: Perf…	Paradigm Spine, LLC	2009	—
*	K101083	DSS Stabilization System Summary page 2 …ation System - Rigid was shown to be substantially equivalent to previously cleared devices (K022949, K024096, K042962, K072022, K08024 I, K090099, K090408, K090408, and K101083) and has the same indications for use, design, function, and materials used. Substantial Equivalence: Performance testing per AS…	Paradigm Spine, LLC	2010	—

Also cleared against K022949: 20 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K120491	DSS Stabilization System-Rigid	Paradigm Spine, LLC	2012	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?

The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
4 of the 41 ancestors have a recall of any class.
Of its descendants, K120491 (Paradigm Spine, LLC, 2012) has gone furthest, with 0 descendants of its own.
20 other devices also cite its predicate K022949.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007high 111 (2010) · low 57 (2024)2026

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

Recalls per year · NKB

1in 2025

2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, 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	38	87	4	34
2008	36	59	5	82
2009	44	71	33	171
2010	37	111	4	462
2011	48	84	3	577
2012	60	79	13	1,747
2013	35	73	0	1,962
2014	46	90	3 (1)	1,671
2015	55	90	3	1,446
2016	50	84	1	1,585
2017	63	69	1	1,618
2018	56	61	3	1,684
2019	39	84	1	1,915
2020	48	68	1	2,076
2021	32	61	0	1,745
2022	34	88	5	1,339
2023	44	72	2	919
2024	39	57	3	1,614
2025	24	61	1	1,171
2026	30	91	3	—

What is it indicated for?

DSSTM Stabilization System - Rigid The DSSTM Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to SI vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and…

Read the full statement (231 words)

DSSTM Stabilization System - Rigid

The DSSTM Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to SI vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: 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; pseudarthrosis; and failed previous fusion. The DSSTM Stabilization System - Rigid is intended to be used with autograft and/or allograft.

DSSTM Stabilization System - Slotted

The DSSTM Stabilization System - Slotted is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudarthrosis).

In addition, the DSSTM Stabilization System - Slotted is indicated for use in patients:

* Who are receiving fusions with autogenous graft only;

* Who are having the device fixed or attached to the lumbar or sacral spine;

* Who are having the device removed after the development of a solid fusion mass.

Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113625 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113625: DSS Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113625

Report an extraction error

Are you the manufacturer?

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