510(k) · Cleared

Cleared

Sierra

K062934510(k) TraditionalCleared Nov 16, 200649-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

Seaspine, Inc. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Nov 16, 2006 as substantially equivalent to K002733 (Depuyacromed, 2000) and 19 other predicates after a 49-day review. Its family tree reaches back 9 generations to 1985. 21 later devices descend from it.

Decided: Nov 16, 2006
Review: 49 days
Class: Class II
Product code: MNI
Recalls: None
Predicates: 20

Its longest line of descent runs back 9 generations to K853033 (1985). 33 ancestors in all. 21 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
5 generations between
3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
1 generation backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
This deviceK062934 SierraSeaspine, Inc. · 2006
Descendant · cites it directly · 9 of its ownK080526 Sierra SystemSeaspine, Inc. · 2008
Descendant · cites it directly · 6 of its ownK133698 Synapse SystemSynthes USA Products, LLC · 2014
Descendant · 2 generations on · 5 of its ownK141897 Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC · 2014
Descendant · cites it directly · 5 of its ownK072729 SierraSeaspine, Inc. · 2008
Descendant · 2 generations on · 4 of its ownK112025 Sure Lok Mini Posterior Cervical/Upper Thoracic SystemSpinal USA · 2011

Show all 9 generations

Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
8 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
7 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
6 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
5 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
4 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
1 generation backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
This deviceK062934 SierraSeaspine, Inc. · 2006

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2008high 3 (2023) · low 0 (2009)2026

Most influential descendants

Showing 5 of 21 · See all

K080526Sierra SystemSeaspine, Inc. · 2008 · cites it directly9descendants
K133698Synapse SystemSynthes USA Products, LLC · 2014 · cites it directly6descendants
K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC · 2014 · 2 generations on5descendants
K072729SierraSeaspine, Inc. · 2008 · cites it directly5descendants
K112025Sure Lok Mini Posterior Cervical/Upper Thoracic SystemSpinal USA · 2011 · 2 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K853033	Hartshill Rect & Wires, Spinal Fixation System	A.W. Showell (Surgicraft), Ltd.	1985	—
−8	K965221	Ransford Cervical Fixation System	Surgicraft, Ltd.	1997	—
−7	K982322	Synthes Spine Occipital-Cervical Plate/Rod and Hook System	Synthes (Usa)	1998	—
−6	K002733	Summit Occipito-Cervico-Thoracic (Oct) Spinal System	Depuyacromed	2000	—
−5	K013222	Summit Occipito-Cervico- Thoracic (Oct) Spinal System	Depuyacromed	2001	—
−4	K022190	Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System	Depuyacromed	2002	—
−3	K030103	Summit Oct Spinal System Minipolyaxial Screws	Depuyacromed	2003	—
−2	K041203	Summit Oct Spinal System	Depuy Spine, Inc.	2004	—
−1	K042508	Sumit Oct Spinal System and Mountaineer Oct Spinal System	Depuy Spine, Inc.	2004	—
0 (this device)	K062934	Sierra	Seaspine, Inc.	2006	—
+1	K080526	Sierra System	Seaspine, Inc.	2008	—
+1	K133698	Synapse System	Synthes USA Products, LLC	2014	—
+2	K141897	Synapse System, Synthes OC Fusion System	Synthes USA Products, LLC	2014	—
+1	K072729	Sierra	Seaspine, Inc.	2008	—
+2	K112025	Sure Lok Mini Posterior Cervical/Upper Thoracic System	Spinal USA	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	4	0
2000	1	0
2001	3	0
2002	5	0
2004	6	0
2005	4	0
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	2	0
2011	1	0
2012	2	0
2013	2	0
2014	2	0
2015	2	0
2016	2	0
2018	2	0
2020	1	0
2021	1	0
2022	1	0
2023	3	0

FIG. 1 — Lineage of K062934, 1985–2023Source: 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 MNI? 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

Get a 510(k) Report

What was it cleared against? (20)

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
*	K002733	Summit Occipito-Cervico-Thoracic (Oct) Spinal System Summary page 1 …Device Trade Name: Sierra TM The devices used for comparison in this summary are DePuy Acromed's Summit and Mountaineer OCT Spinal Systems (K002733, K010681, K013222, K022190, K030103, K041203, and K042508), Interpore Cross International's Altius OCT System (K022048, K03…	Depuyacromed	2000	—
*	K010681	Summit Occipito-Cervico-Thoracic (Oct) Spinal System Summary page 1 …Trade Name: Sierra TM The devices used for comparison in this summary are DePuy Acromed's Summit and Mountaineer OCT Spinal Systems (K002733, K010681, K013222, K022190, K030103, K041203, and K042508), Interpore Cross International's Altius OCT System (K022048, K033961, and…	Depuyacromed	2001	—
*	K013222	Summit Occipito-Cervico- Thoracic (Oct) Spinal System Summary page 1 …me: Sierra TM The devices used for comparison in this summary are DePuy Acromed's Summit and Mountaineer OCT Spinal Systems (K002733, K010681, K013222, K022190, K030103, K041203, and K042508), Interpore Cross International's Altius OCT System (K022048, K033961, and K043229)…	Depuyacromed	2001	—
*	K022190	Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System Summary page 1 …Sierra TM The devices used for comparison in this summary are DePuy Acromed's Summit and Mountaineer OCT Spinal Systems (K002733, K010681, K013222, K022190, K030103, K041203, and K042508), Interpore Cross International's Altius OCT System (K022048, K033961, and K043229), and Med…	Depuyacromed	2002	—
*	K030103	Summit Oct Spinal System Minipolyaxial Screws Summary page 1 …Sierra TM The devices used for comparison in this summary are DePuy Acromed's Summit and Mountaineer OCT Spinal Systems (K002733, K010681, K013222, K022190, K030103, K041203, and K042508), Interpore Cross International's Altius OCT System (K022048, K033961, and K043229), and Medtronic Sofam…	Depuyacromed	2003	—
*	K041203	Summit Oct Spinal System Summary page 1 …TM The devices used for comparison in this summary are DePuy Acromed's Summit and Mountaineer OCT Spinal Systems (K002733, K010681, K013222, K022190, K030103, K041203, and K042508), Interpore Cross International's Altius OCT System (K022048, K033961, and K043229), and Medtronic Sofamor Danek'…	Depuy Spine, Inc.	2004	—
*	K042508	Sumit Oct Spinal System and Mountaineer Oct Spinal System Summary page 1 …evices used for comparison in this summary are DePuy Acromed's Summit and Mountaineer OCT Spinal Systems (K002733, K010681, K013222, K022190, K030103, K041203, and K042508), Interpore Cross International's Altius OCT System (K022048, K033961, and K043229), and Medtronic Sofamor Danek's Vertex R…	Depuy Spine, Inc.	2004	—
*	K022048	Interpore Cross International (Ici) Occipito-Cervico-Thoracic (Oct) Rod and Plate System Summary page 1 …ummit and Mountaineer OCT Spinal Systems (K002733, K010681, K013222, K022190, K030103, K041203, and K042508), Interpore Cross International's Altius OCT System (K022048, K033961, and K043229), and Medtronic Sofamor Danek's Vertex Reconstructive System (K003780, K022015, K023555, K042402, K04249…	Interpore Cross Intl.	2002	—
*	K033961	Altius Oct System Summary page 1 …Mountaineer OCT Spinal Systems (K002733, K010681, K013222, K022190, K030103, K041203, and K042508), Interpore Cross International's Altius OCT System (K022048, K033961, and K043229), and Medtronic Sofamor Danek's Vertex Reconstructive System (K003780, K022015, K023555, K042402, K042498, K04…	Interpore Cross Intl.	2004	—
*	K043229	Modification to Altius Oct System Summary page 1 …er OCT Spinal Systems (K002733, K010681, K013222, K022190, K030103, K041203, and K042508), Interpore Cross International's Altius OCT System (K022048, K033961, and K043229), and Medtronic Sofamor Danek's Vertex Reconstructive System (K003780, K022015, K023555, K042402, K042498, K042524, K052180…	Interpore Cross Intl.	2004	—
*	K003780	Vertex Reconstruction System Summary page 1 …41203, and K042508), Interpore Cross International's Altius OCT System (K022048, K033961, and K043229), and Medtronic Sofamor Danek's Vertex Reconstructive System (K003780, K022015, K023555, K042402, K042498, K042524, K052180, K052376, K052734, and K053483).…	Medtronic Sofamor Danek, Inc.	2001	—
*	K022015	Modification to Vertex Reconstruction System Summary page 1 …d K042508), Interpore Cross International's Altius OCT System (K022048, K033961, and K043229), and Medtronic Sofamor Danek's Vertex Reconstructive System (K003780, K022015, K023555, K042402, K042498, K042524, K052180, K052376, K052734, and K053483).…	Medtronic Sofamor Danek, Inc.	2002	—
*	K023555	Modification to Vertex Reconstruction System Summary page 1 …), Interpore Cross International's Altius OCT System (K022048, K033961, and K043229), and Medtronic Sofamor Danek's Vertex Reconstructive System (K003780, K022015, K023555, K042402, K042498, K042524, K052180, K052376, K052734, and K053483).…	Medtronic Sofamor Danek, Inc.	2002	—
*	K042402	Modification to Vertex Reconstruction System Summary page 1 …ore Cross International's Altius OCT System (K022048, K033961, and K043229), and Medtronic Sofamor Danek's Vertex Reconstructive System (K003780, K022015, K023555, K042402, K042498, K042524, K052180, K052376, K052734, and K053483).…	Medtronic Sofamor Danek, Inc.	2004	—
*	K042498	Vertex Reconstruction System Summary page 1 …International's Altius OCT System (K022048, K033961, and K043229), and Medtronic Sofamor Danek's Vertex Reconstructive System (K003780, K022015, K023555, K042402, K042498, K042524, K052180, K052376, K052734, and K053483).…	Medtronic Sofamor Danek	2004	1
*	K042524	Modification to Vertex Reconstruction System Summary page 1 …al's Altius OCT System (K022048, K033961, and K043229), and Medtronic Sofamor Danek's Vertex Reconstructive System (K003780, K022015, K023555, K042402, K042498, K042524, K052180, K052376, K052734, and K053483).…	Medtronic Sofamor Danek	2004	—
*	K052180	Modification to Vertex Reconstruction System Summary page 1 …us OCT System (K022048, K033961, and K043229), and Medtronic Sofamor Danek's Vertex Reconstructive System (K003780, K022015, K023555, K042402, K042498, K042524, K052180, K052376, K052734, and K053483). 24…	Medtronic Sofamor Danek	2005	—
*	K052376	Modification to: Vertex Reconstruction System Summary page 1 …System (K022048, K033961, and K043229), and Medtronic Sofamor Danek's Vertex Reconstructive System (K003780, K022015, K023555, K042402, K042498, K042524, K052180, K052376, K052734, and K053483). 24 === Page…	Medtronic Sofamor Danek	2005	—
*	K052734	Modification to: Vertex Reconstruction System Summary page 1 …K022048, K033961, and K043229), and Medtronic Sofamor Danek's Vertex Reconstructive System (K003780, K022015, K023555, K042402, K042498, K042524, K052180, K052376, K052734, and K053483). 24…	Medtronic Sofamor Danek	2005	—
*	K053483	Modification to Vertex Reconstruction System Summary page 1 …961, and K043229), and Medtronic Sofamor Danek's Vertex Reconstructive System (K003780, K022015, K023555, K042402, K042498, K042524, K052180, K052376, K052734, and K053483). 24…	Medtronic Sofamor Danek	2006	—

Also cleared against K002733: 15 other devices →

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K080526	Sierra System	Seaspine, Inc.	2008	9
K133698	Synapse System	Synthes USA Products, LLC	2014	6
K072729	Sierra	Seaspine, Inc.	2008	5
K122163	Certex Spinal Implant System	X-Spine Systems, Inc.	2012	2
K120467	Spinal Elements Posterior Cervical/Thoracic Spinal System	Spinal Elements, Inc.	2012	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 21 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
1 of the 33 ancestors has a recall of any class.
Of its descendants, K080526 (Seaspine, Inc., 2008) has gone furthest, with 9 descendants of its own.
15 other devices also cite its predicate K002733.

How does its category compare?

All MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNI

1in 2017

2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007high 26 (2007) · low 0 (2011)2026

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

Adverse event reports per year · MNI

80in 2025

2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, 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	20	82	26	83
2008	23	64	8	108
2009	18	86	3	138
2010	16	74	1	126
2011	17	111	0	146
2012	19	75	1	200
2013	14	77	4	824
2014	6	104	0	301
2015	12	54	1	260
2016	7	168	0	117
2017	1	—	0	247
2018	0	—	1	134
2019	0	—	0	188
2020	0	—	0	115
2021	0	—	0	270
2022	0	—	0	214
2023	0	—	0	122
2024	0	—	0	114
2025	0	—	0	80
2026	0	—	0	—

What is it indicated for?

The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows: * degenerative disc disease (DDD) as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, * spondylolisthesis, * trauma (i.e., fracture or dislocation), * spinal stenosis, * atlantoaxial fracture with…

Read the full statement (124 words)

The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows:

* degenerative disc disease (DDD) as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,

* spondylolisthesis,

* trauma (i.e., fracture or dislocation),

* spinal stenosis,

* atlantoaxial fracture with instability,

* occipitocervical dislocation,

* revision of previous cervical spine surgery, and/or

* spinal tumor.

The occipital bone screws are limited to occipital fixation only.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062934 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062934: Sierra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062934

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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