510(k) · Cleared

Cleared

Frontier Anterior Scoliosis System

K012916510(k) TraditionalCleared Nov 27, 200189-day reviewClass II21 CFR 888.3060

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

Depuy Acromed, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Nov 27, 2001 as substantially equivalent to K953915 (Depuy, Inc., 1996) and 2 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1996. 1 of the 605 devices in its family, counting itself, has a Class I recall. 601 later devices descend from it.

Decided: Nov 27, 2001
Review: 89 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K953915 (1996). 3 ancestors in all. 601 later devices descend from it, 3 citing it directly. 1 of the 605 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK953915 Moss Miami Spinal System (Anterior Use)Depuy, Inc. · 1996
This deviceK012916 Frontier Anterior Scoliosis SystemDepuy Acromed, Inc. · 2001
Descendant · cites it directly · 582 of its ownK071668 Orthobiom Spinal SystemParadigm Spine · 2008
Descendant · 2 generations on · 581 of its ownK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
Descendant · 3 generations on · 269 of its ownK110070 TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2011
Descendant · 3 generations on · 261 of its ownK111457 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2011
Descendant · 3 generations on · 260 of its ownK113395 Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012

Showing 5 of 601 descendants. See all descendants

Descendants cleared per year

2004high 60 (2023) · low 0 (2005)2026

Class I recalls in this family

K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 601 · See all

K071668Orthobiom Spinal SystemParadigm Spine · 2008 · cites it directly582descendants
K091445CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010 · 2 generations on581descendants
K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2011 · 3 generations on269descendants
K111457CD Horizon Spinal SystemMedtronic Sofamor Danek · 2011 · 3 generations on261descendants
K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012 · 3 generations on260descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K953915	Moss Miami Spinal System (Anterior Use)	Depuy, Inc.	1996	—
0 (this device)	K012916	Frontier Anterior Scoliosis System	Depuy Acromed, Inc.	2001	—
+1	K071668	Orthobiom Spinal System	Paradigm Spine	2008	—
+2	K091445	CD Horizon Spinal System	Medtronic Sofamor Danek	2010	—
+3	K110070	TSRH Spinal System	Medtronic Sofamor Danck USA, Inc.	2011	—
+3	K111457	CD Horizon Spinal System	Medtronic Sofamor Danek	2011	—
+3	K113395	Revere 4.5 Stabilization System	Globus Medical, Inc.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2008	1	0
2010	2	0
2011	5	0
2012	15	0
2013	25	0
2014	32	0
2015	43	0
2016	36	0
2017	41	0
2018	41	0
2019	29	0
2020	36	0
2021	32	1
2022	42	0
2023	60	0
2024	60	0
2025	51	0
2026	49	0

FIG. 1 — Lineage of K012916, 1996–2026Source: 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.

1 device in this family has a Class I recall. 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 KWQ device

#1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 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? (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
*	K953915	Moss Miami Spinal System (Anterior Use) Summary page 1 …001 CLASSIFICATION NAME: Spinal Intervertebral Body Fixation Orthosis PROPRIETARY NAME: Frontier Anterior Scoliosis System PREDICATE DEVICES: MOSS MIAMI Spinal System (K953915) KANEDA™ Anterior Scoliosis System (K974757) CD HORIZON® ECLIPSE™ (K001066) DESCRIPTION: The FRONTIER Anterior Scoliosis System…	Depuy, Inc.	1996	—
*	K974757	Kaneda Anterior Scoliosis System Kass Summary page 1 …ral Body Fixation Orthosis PROPRIETARY NAME: Frontier Anterior Scoliosis System PREDICATE DEVICES: MOSS MIAMI Spinal System (K953915) KANEDA™ Anterior Scoliosis System (K974757) CD HORIZON® ECLIPSE™ (K001066) DESCRIPTION: The FRONTIER Anterior Scoliosis System consists of spinal rods, spinal screws, spi…	Acromed Corp.	1998	—
*	K001066	CD Horizon Eclipse Summary page 1 …IETARY NAME: Frontier Anterior Scoliosis System PREDICATE DEVICES: MOSS MIAMI Spinal System (K953915) KANEDA™ Anterior Scoliosis System (K974757) CD HORIZON® ECLIPSE™ (K001066) DESCRIPTION: The FRONTIER Anterior Scoliosis System consists of spinal rods, spinal screws, spinal staples, and spinal washers.…	Medtronic Sofamor Danek, Inc.	2000	—

Also cleared against K953915: 7 other devices →

What descends from it? (601)

See all 601

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

Number	Device	Applicant	Decided	Descendants
K071668	Orthobiom Spinal System	Paradigm Spine	2008	582
K041205	Expedium Anterior Spine System	Depuy Spine, Inc.	2004	140
K192281	AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…	Medos International SARL	2019	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

None of the 3 ancestors has a recall.
Of its descendants, K071668 (Paradigm Spine, 2008) has gone furthest, with 582 descendants of its own.
7 other devices also cite its predicate K953915.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWQ

7in 2025

2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007high 124 (2014) · low 55 (2020)2026

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

Recalls per year · KWQ

1in 2018

2007high 35 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWQ

248in 2025

2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, 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	27	101	2	288
2008	32	70	33	348
2009	23	90	35	355
2010	23	104	2	691
2011	22	95	5	415
2012	26	90	7	544
2013	22	88	6	796
2014	17	124	0	546
2015	25	102	2	562
2016	15	121	9	502
2017	20	67	8	492
2018	22	95	1	341
2019	26	81	0	298
2020	26	55	0	400
2021	17	59	0	591
2022	18	85	0	392
2023	16	59	0	320
2024	17	64	0	419
2025	7	64	0	248
2026	10	76	0	—

What is it indicated for?

The FRONTIER Anterior Scoliosis System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine, with all metal at least 1 cm from a major vessel. The FRONTIER Anterior Scoliosis System may be used in either thoracoscopic procedures or open procedures. The FRONTIER Anterior Scoliosis System is intended to provide temporary stabilization as an adjunct to spinal bone grafting processes. Specific indications are: 1. Idiopathic…

Read the full statement (201 words)

The FRONTIER Anterior Scoliosis System is intended to provide temporary stabilization as an adjunct to spinal bone grafting processes. Specific indications are:

1. Idiopathic scoliosis.

2. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).

3. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele.

Neuromuscular scoliosis/kyphoscoliosis.

Spinal fractures (acute reduction or late deformity).

Revision surgery.

Tumor.

The FRONTIER Anterior Scoliosis System can also be used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Indications for these scoliotic uses include:

. Collapsing and unstable paralytic deformity.

2. Progressively increasing scoliosis.

3. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or

collapse.

Inability to maintain sitting balance, necessitating the use of hands.

Increasing pelvic obliquity coincident with back pain or losg of sitting balance.

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/K012916 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012916: Frontier Anterior Scoliosis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012916

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026