510(k) · Cleared

Cleared

Foundation Spinal System

K120074510(k) TraditionalCleared Mar 14, 201264-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

The Skeletal Design Partnership, Ltd. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Mar 14, 2012 as substantially equivalent to K971248 (Acromed Corp., 1997) and 8 other predicates after a 64-day review. Its family tree reaches back 4 generations to 1990. 2 later devices descend from it.

Decided: Mar 14, 2012
Review: 64 days
Class: Class II
Product code: NKB
Recalls: None
Predicates: 9

Its longest line of descent runs back 4 generations to K901587 (1990). 32 ancestors in all, the oldest K873826 (1988). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
3 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
2 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
1 generation backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
This deviceK120074 Foundation Spinal SystemThe Skeletal Design Partnership, Ltd. · 2012
Descendant · cites it directly · 1 of its ownK151770 Libra Pedicle Screw SystemSpinal Balance, Inc. · 2015
Descendant · 2 generations on · 0 of its ownK162750 Libra Pedicle Screw SystemSpinal Balance, Inc. · 2016

Most influential descendants

Showing 2 of 2 · See all

K151770Libra Pedicle Screw SystemSpinal Balance, Inc. · 2015 · cites it directly1descendant
K162750Libra Pedicle Screw SystemSpinal Balance, Inc. · 2016 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K901587	TSRH Sacral L-Connector	Danek Medical, Inc.	1990	—
−3	K950099	Synergy (TM) TI Posterior Spinal System	Buckman Co., Inc.	1997	—
−2	K973836	Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross…	Cross Medical Products, Inc.	1998	—
−1	K974749	Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy…	Cross Medical Products, Inc.	1998	—
0 (this device)	K120074	Foundation Spinal System	The Skeletal Design Partnership, Ltd.	2012	—
+1	K151770	Libra Pedicle Screw System	Spinal Balance, Inc.	2015	—
+2	K162750	Libra Pedicle Screw System	Spinal Balance, Inc.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1990	1	0
1992	5	0
1993	3	0
1994	2	0
1995	3	0
1996	1	0
1997	2	0
1998	1	0
1999	1	0
2000	1	0
2001	1	0
2002	1	0
2003	1	0
2004	3	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2016	1	0

FIG. 1 — Lineage of K120074, 1990–2016Source: 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? (9)

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
*	K971248	Kaneda SR Anterior Spinal System Summary page 2 …s are manufactured from titanium alloy (Ti-6A1-4V ELI) as described by ASTMV Fl 36. Predicate Devices: Kaneda SR Spinal System (K971248) CD HORIZON® (K031655/K041460), ExpediumnTm 5.5 Ti Spine System (K041 11 9/K051 024)…	Acromed Corp.	1997	—
*	K031655	CD Horizon Spinal System Summary page 2 …titanium alloy (Ti-6A1-4V ELI) as described by ASTMV Fl 36. Predicate Devices: Kaneda SR Spinal System (K971248) CD HORIZON® (K031655/K041460), ExpediumnTm 5.5 Ti Spine System (K041 11 9/K051 024) Moss® Miami (K992168/K02…	Medtronic Sofamor Danek USA, Inc.	2003	1
*	K041460	CD Horizon Spinal System Summary page 2 …anium alloy (Ti-6A1-4V ELI) as described by ASTMV Fl 36. Predicate Devices: Kaneda SR Spinal System (K971248) CD HORIZON® (K031655/K041460), ExpediumnTm 5.5 Ti Spine System (K041 11 9/K051 024) Moss® Miami (K992168/K022623) an…	Medtronic Sofamor Danek USA, Inc.	2004	—
*	K041119	Expedium Spine System Summary page 2 …ge 2 === Predicate Devices: Kaneda SR Spinal System (K971248) CD HORIZON® (K031655/K041460), ExpediumnTm 5.5 Ti Spine System (K041 11 9/K051 024) Moss® Miami (K992168/K022623) and the Synergy TM VLS (K950099/K974749) Techno…	Depuy Spine, Inc.	2004	—
*	K051024	Expedium Spine System Summary page 2 …redicate Devices: Kaneda SR Spinal System (K971248) CD HORIZON® (K031655/K041460), ExpediumnTm 5.5 Ti Spine System (K041 11 9/K051 024) Moss® Miami (K992168/K022623) and the Synergy TM VLS (K950099/K974749) Technological…	Depuy Spine, Inc.	2005	—
*	K992168	Moss Miami 6.35MM Polyaxial Screw Summary page 2 …(K971248) CD HORIZON® (K031655/K041460), ExpediumnTm 5.5 Ti Spine System (K041 11 9/K051 024) Moss® Miami (K992168/K022623) and the Synergy TM VLS (K950099/K974749) Technological The Foundation Spinal System possesse…	Depuyacromed	1999	—
*	K022623	5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) Summary page 2 …) CD HORIZON® (K031655/K041460), ExpediumnTm 5.5 Ti Spine System (K041 11 9/K051 024) Moss® Miami (K992168/K022623) and the Synergy TM VLS (K950099/K974749) Technological The Foundation Spinal System possesses the sa…	Depuyacromed	2002	—
*	K950099	Synergy (TM) TI Posterior Spinal System Summary page 2 …ExpediumnTm 5.5 Ti Spine System (K041 11 9/K051 024) Moss® Miami (K992168/K022623) and the Synergy TM VLS (K950099/K974749) Technological The Foundation Spinal System possesses the same technological Characteristics: characteristics…	Buckman Co., Inc.	1997	—
*	K974749	Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior… Summary page 2 …ExpediumnTm 5.5 Ti Spine System (K041 11 9/K051 024) Moss® Miami (K992168/K022623) and the Synergy TM VLS (K950099/K974749) Technological The Foundation Spinal System possesses the same technological Characteristics: characteristics as the p…	Cross Medical Products, Inc.	1998	—

Also cleared against K971248: 6 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K151770	Libra Pedicle Screw System	Spinal Balance, Inc.	2015	1

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 6.2 years on median.
1 of the 32 ancestors has a recall of any class.
Of its descendants, K151770 (Spinal Balance, Inc., 2015) has gone furthest, with 1 descendant of its own.
6 other devices also cite its predicate K971248.

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?

The Foundation Spinal System is intended for thoracolumbar (T4-L4) anterolateral screw fixation and posterior, non-cervical (Ti-Si) pedicle and non-pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120074 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120074: Foundation 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/K120074

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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