510(k) · Cleared

Cleared

Stainless Steel Spinal System

K120829510(k) SpecialCleared May 30, 201272-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

Theken Spine, LLC · NKB Thoracolumbosacral Pedicle Screw System

Cleared on May 30, 2012 as substantially equivalent to K100970 (Theken Spine, LLC, 2010) after a 72-day review. Its family tree reaches back 5 generations to 1996.

Decided: May 30, 2012
Review: 72 days
Class: Class II
Product code: NKB
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K955348 (1996). 7 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
4 generations backK041592 Coral Spinal SystemTheken Surgical · 2004 · Recalled
3 generations backK070962 Coral Pedicle Screw SystemTheken Spine, LLC · 2007
2 generations backK081414 Modification to Coral Spinal SystemTheken Spine, LLC · 2008
1 generation backK100970 Stainless Steel Spinal SystemTheken Spine, LLC · 2010
This deviceK120829 Stainless Steel Spinal SystemTheken Spine, LLC · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K955348	Titanium Moss Miami Spinal System	Depuy, Inc.	1996	—
−4	K041592	Coral Spinal System	Theken Surgical	2004	1
−3	K070962	Coral Pedicle Screw System	Theken Spine, LLC	2007	—
−2	K081414	Modification to Coral Spinal System	Theken Spine, LLC	2008	—
−1	K100970	Stainless Steel Spinal System	Theken Spine, LLC	2010	—
0 (this device)	K120829	Stainless Steel Spinal System	Theken Spine, LLC	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2005	1	0

FIG. 1 — Lineage of K120829, 1996–2012Source: 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

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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
*	K100970	Stainless Steel Spinal System Summary page 1 …)(2) - Spondylolisthesis Spinal Fixation System Predicate Device: Stainless Steel Spinal System, Theken Spine, K100970 Device Description: The purpose of this submission is the addition of alternative…	Theken Spine, LLC	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?

The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
2 of the 7 ancestors have a recall of any class.

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?

Read the full statement (99 words)

The Stainless Steel Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedlicle screw fixation system (TI-52/ilium), a posterior non-pedicle screw fixation system (Tl-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120829 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120829: Stainless Steel Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120829

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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