510(k) · Cleared

Cleared

V2F Anterior Fixation System

K122733510(k) TraditionalCleared Dec 7, 201292-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

Zimmer Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Dec 7, 2012 as substantially equivalent to K021564 (Spinal Concepts, Inc., 2002) and 1 other predicate after a 92-day review. Its family tree reaches back 1 generation to 2002. 17 later devices descend from it.

Decided: Dec 7, 2012
Review: 92 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K020244 (2002). 2 ancestors in all. 17 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK020244 Synthes Thoracolumbar Spine Locking Plate (TSLP)Synthes Spine · 2002
This deviceK122733 V2F Anterior Fixation SystemZimmer Spine, Inc. · 2012
Descendant · cites it directly · 16 of its ownK143626 inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic…Zimmer Spine, Inc. · 2015
Descendant · 2 generations on · 13 of its ownK192481 AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020
Descendant · 3 generations on · 10 of its ownK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
Descendant · 4 generations on · 6 of its ownK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
Descendant · 2 generations on · 3 of its ownK223719 Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2015high 7 (2023) · low 0 (2016)2026

Most influential descendants

Showing 5 of 17 · See all

K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…Zimmer Spine, Inc. · 2015 · cites it directly16descendants
K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020 · 2 generations on13descendants
K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine · 2021 · 3 generations on10descendants
K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc. · 2022 · 4 generations on6descendants
K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K020244	Synthes Thoracolumbar Spine Locking Plate (TSLP)	Synthes Spine	2002	—
0 (this device)	K122733	V2F Anterior Fixation System	Zimmer Spine, Inc.	2012	—
+1	K143626	inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical…	Zimmer Spine, Inc.	2015	—
+2	K192481	AccelFix Lumbar Plate System	L&K BIOMED Co., Ltd.	2020	—
+3	K210035	ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System…	Aegis Spine	2021	—
+4	K221050	ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon…	Aegis Spine, Inc.	2022	—
+2	K223719	Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System	Aegis Spine, Inc.	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2020	1	0
2021	2	0
2022	2	0
2023	7	0
2024	2	0
2026	2	0

FIG. 1 — Lineage of K122733, 2002–2026Source: 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 KWQ? 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

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What was it cleared against? (2)

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
*	K021564	Incompass Spinal Fixation System	Spinal Concepts, Inc.	2002	1
*	K020244	Synthes Thoracolumbar Spine Locking Plate (TSLP) Summary page 1 …InCompass Spinal Fixation System (K(02 1564) Synthes Thoracolumbar Spine Locking Plate (TSLP) System (K(020244) Device Description: The V2P~m Anterior Fixation System is a temporary supplemental fixation device consisting of: thoracolumb…	Synthes Spine	2002	—

Also cleared against K021564: 6 other devices →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K143626	inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…	Zimmer Spine, Inc.	2015	16

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K143626 (Zimmer Spine, Inc., 2015) has gone furthest, with 16 descendants of its own.
6 other devices also cite its predicate K021564.

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. 2012, this device’s year, is highlighted.

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 V2FTM Anterior Fixation System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis or a failed previous spine surgery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122733 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122733: V2F Anterior Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122733

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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