510(k) · Cleared
ClearedCertex Oct Spinal Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Spine Systems, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Dec 11, 2013 as substantially equivalent to K122163 (X-Spine Systems, Inc., 2012) and 1 other predicate after a 72-day review. Its family tree reaches back 11 generations to 1985. 1 later device descends from it.
- Decided
- Dec 11, 2013
- Review
- 72 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K853033 (1985). 41 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 7 generations between
- 3 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK062934 SierraSeaspine, Inc. · 2006
- 1 generation backK122163 Certex Spinal Implant SystemX-Spine Systems, Inc. · 2012
- This deviceK133094 Certex Oct Spinal Implant SystemX-Spine Systems, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK160428 Certex Spinal Fixation SystemX-Spine Systems, Inc. · 2016
Show all 11 generations
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 9 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 8 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 7 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 6 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 5 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 4 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 3 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK062934 SierraSeaspine, Inc. · 2006
- 1 generation backK122163 Certex Spinal Implant SystemX-Spine Systems, Inc. · 2012
- This deviceK133094 Certex Oct Spinal Implant SystemX-Spine Systems, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K160428Certex Spinal Fixation SystemX-Spine Systems, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −10 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −9 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −8 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −7 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −6 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −5 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −4 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −3 | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | K062934 | Sierra | Seaspine, Inc. | 2006 | — |
| −1 | K122163 | Certex Spinal Implant System | X-Spine Systems, Inc. | 2012 | — |
| 0 (this device) | K133094 | Certex Oct Spinal Implant System | X-Spine Systems, Inc. | 2013 | — |
| +1 | K160428 | Certex Spinal Fixation System | X-Spine Systems, Inc. | 2016 | — |
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 |
| 2003 | 1 | 0 |
| 2004 | 6 | 0 |
| 2005 | 6 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K122163 | Certex Spinal Implant SystemSummary page 2…anium alloy in accordance with ASTM F1 36 and will be provided clean but non-sterile. PREDICATE DEVICES * X-spine Systems, Inc. - Centex Spinal Implant System (K122163) * Aesculap, LLC - S4 Cervical Occipital Plate Spinal System (K062012) EQUIVALENCE TO MARKETED PRODUCT X-spine Systems… | 2012 |
| * | K062012 | S4 Cervical Occipital Plate Spinal SystemSummary page 2…erile. PREDICATE DEVICES * X-spine Systems, Inc. - Centex Spinal Implant System (K122163) * Aesculap, LLC - S4 Cervical Occipital Plate Spinal System (K062012) EQUIVALENCE TO MARKETED PRODUCT X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes of FDA's… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160428 | Certex Spinal Fixation System | 2016 | 0 |
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 28 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 41 ancestors have a recall of any class.
- Of its descendants, K160428 (X-Spine Systems, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K122163.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 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 intended use of the Certex OCT Spinal Implant System is to promote fusion of the occipito-cervico-thoracic regions of the spine (Occiput - T3 inclusive). The indications for use are as follows: - Degenerative Disc Disease (as identified by neck or back 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, *…
Read the full statement (168 words)
The intended use of the Certex OCT Spinal Implant System is to promote fusion of the occipito-cervico-thoracic regions of the spine (Occiput - T3 inclusive). The indications for use are as follows:
- Degenerative Disc Disease (as identified by neck or back 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,
* Atlanto-axial fracture with instability,
* Failed previous fusion,
* Occipito-cervical dislocation,
* Revision of previous cervical spine surgery,
* Spinal tumors.
The occipital bone screws are limited to occipital fixation only.
The hooks and rods are intended to provide stabilization and promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic spine (C1-T3).
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for purposes of anchoring an OCT construct, and are not intended for treatment of thoracic conditions. Screws are not intended to be placed in the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133094: Certex Oct Spinal Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133094
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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