510(k) · Cleared

Cleared

Anatomica Posterior Cervical Fixation System

K061943510(k) TraditionalCleared May 25, 2007319-day reviewClass II21 CFR 888.3050

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

Anatomica AB · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on May 25, 2007 as substantially equivalent to K033961 (Interpore Cross Intl., 2004) and 1 other predicate after a 319-day review. Its family tree reaches back 1 generation to 2004. 2 later devices descend from it.

Decided: May 25, 2007
Review: 319 days
Class: Class II
Product code: KWP
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K033961 (2004). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK033961 Altius Oct SystemInterpore Cross Intl. · 2004
This deviceK061943 Anatomica Posterior Cervical Fixation SystemAnatomica AB · 2007
Descendant · cites it directly · 1 of its ownK132122 Kestrel Posterior Cervical Spine SystemOmni Surgical, LLC Dba Spine360 · 2014
Descendant · 2 generations on · 0 of its ownK181350 ASTRA-OCT Spine SystemSpinecraft, LLC · 2018

Most influential descendants

Showing 2 of 2 · See all

K132122Kestrel Posterior Cervical Spine SystemOmni Surgical, LLC Dba Spine360 · 2014 · cites it directly1descendant
K181350ASTRA-OCT Spine SystemSpinecraft, LLC · 2018 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K033961	Altius Oct System	Interpore Cross Intl.	2004	—
0 (this device)	K061943	Anatomica Posterior Cervical Fixation System	Anatomica AB	2007	—
+1	K132122	Kestrel Posterior Cervical Spine System	Omni Surgical, LLC Dba Spine360	2014	—
+2	K181350	ASTRA-OCT Spine System	Spinecraft, LLC	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2018	1	0

FIG. 1 — Lineage of K061943, 2004–2018Source: 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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
*	K033961	Altius Oct System Summary page 2 …k) Premarket Notification Anatomica AB Predicate Devices: Altius OCT System by Interpore Cross, 5 10(k) K033961 and K043229. Device Description : The Anatomica Cervical System is a titanium spinal fixation system for occipito-cervic…	Interpore Cross Intl.	2004	—
*	K043229	Modification to Altius Oct System Summary page 2 …Notification Anatomica AB Predicate Devices: Altius OCT System by Interpore Cross, 5 10(k) K033961 and K043229. Device Description : The Anatomica Cervical System is a titanium spinal fixation system for occipito-cervico-thoracic…	Interpore Cross Intl.	2004	—

Also cleared against K033961: 12 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
K132122	Kestrel Posterior Cervical Spine System	Omni Surgical, LLC Dba Spine360	2014	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?

None of the 2 ancestors has a recall.
Of its descendants, K132122 (Omni Surgical, LLC Dba Spine360, 2014) has gone furthest, with 1 descendant of its own.
12 other devices also cite its predicate K033961.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · KWP

9in 2015

2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007high 23 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWP

494in 2025

2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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	14	96	2	210
2008	13	50	1	594
2009	12	89	23	682
2010	14	186	2	474
2011	12	67	6	792
2012	18	112	1	918
2013	12	99	3	1,090
2014	13	138	0	1,022
2015	9	113	1	1,348
2016	0	—	3	1,379
2017	0	—	0	864
2018	0	—	1	657
2019	0	—	2	518
2020	0	—	0	796
2021	0	—	0	525
2022	0	—	2	335
2023	0	—	0	332
2024	0	—	0	436
2025	0	—	0	494
2026	0	—	0	—

What is it indicated for?

The Anatomica Posterior Cervical Fixation System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3). The system is intended for posterior, cervical, non-pedicle fixation, or for posterior, noncervical pedicle fixation for the following indications: * degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)…

Read the full statement (143 words)

* degenerative disc disease(DDD) (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;

· pseudoarthrosis; and

* failed previous fusion.

Occipital bone screws are limited to occipital fixation only. Pedicle bone screws are limited to

placement in the upper thoracic spine (TI, T3) when treating thoracic conditions only. Pedicle

screws are not intended to be placed in the cervical spine. Hooks and wires (not pedicle screws)

are used to achieve cervical fusion for the occipital/cervical loop.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061943 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061943: Anatomica Posterior Cervical 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/K061943

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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