510(k) · Cleared
ClearedCertex Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Spine Systems, Inc. · NKG Posterior Cervical Screw System
Cleared on May 5, 2016 as substantially equivalent to K151938 (Aesculap Implant Systems, LLC, 2015) and 2 other predicates after a 79-day review. Its family tree reaches back 12 generations to 1985.
- Decided
- May 5, 2016
- Review
- 79 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K853033 (1985). 47 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 8 generations between
- 3 generations backK062934 SierraSeaspine, Inc. · 2006
- 2 generations backK122163 Certex Spinal Implant SystemX-Spine Systems, Inc. · 2012
- 1 generation backK133094 Certex Oct Spinal Implant SystemX-Spine Systems, Inc. · 2013
- This deviceK160428 Certex Spinal Fixation SystemX-Spine Systems, Inc. · 2016
Show all 12 generations
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 10 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 9 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 8 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 7 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 6 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 5 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 4 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 3 generations backK062934 SierraSeaspine, Inc. · 2006
- 2 generations backK122163 Certex Spinal Implant SystemX-Spine Systems, Inc. · 2012
- 1 generation backK133094 Certex Oct Spinal Implant SystemX-Spine Systems, Inc. · 2013
- This deviceK160428 Certex Spinal Fixation SystemX-Spine Systems, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −11 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −10 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −9 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −8 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −7 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −6 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −5 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −4 | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −3 | K062934 | Sierra | Seaspine, Inc. | 2006 | — |
| −2 | K122163 | Certex Spinal Implant System | X-Spine Systems, Inc. | 2012 | — |
| −1 | K133094 | Certex Oct Spinal Implant System | X-Spine Systems, Inc. | 2013 | — |
| 0 (this device) | K160428 | Certex Spinal Fixation System | X-Spine Systems, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 6 | 0 |
| 2003 | 1 | 0 |
| 2004 | 6 | 0 |
| 2005 | 6 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 2 | 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 NKG? 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 NKG device
- #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K151938 | S4 Cervical Spinal and Occiput SystemsSummary page 5…Class: Unclassified Product Codes: NKG, KWP Primary Predicate: Aesculap S4 Cervical Occipital Plate Spinal System (K151938) Additional Predicates: Certex Spinal Fixation System (K133094, K122163) Aesculap S4 Cerv… | 2015 |
| * | K133094 | Certex Oct Spinal Implant SystemSummary page 5…NKG, KWP Primary Predicate: Aesculap S4 Cervical Occipital Plate Spinal System (K151938) Additional Predicates: Certex Spinal Fixation System (K133094, K122163) Aesculap S4 Cervical Occipital Plate Spinal System (K151938) Indications For Use: The… | 2013 |
| * | K122163 | Certex Spinal Implant SystemSummary page 5…KWP Primary Predicate: Aesculap S4 Cervical Occipital Plate Spinal System (K151938) Additional Predicates: Certex Spinal Fixation System (K133094, K122163) Aesculap S4 Cervical Occipital Plate Spinal System (K151938) Indications For Use: The intended… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 47 ancestors have a recall of any class.
- 1 other device also cites its predicate K151938.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NKG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKG
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKG
153in 2025
MAUDE reports naming product code NKG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 17 | 71 | 0 | 4 |
| 2016 | 16 | 87 | 0 | 73 |
| 2017 | 15 | 108 | 0 | 99 |
| 2018 | 12 | 61 | 1 | 127 |
| 2019 | 8 | 50 | 1 | 214 |
| 2020 | 14 | 59 | 2 | 236 |
| 2021 | 7 | 56 | 0 | 704 |
| 2022 | 7 | 108 | 0 | 175 |
| 2023 | 10 | 58 | 0 | 131 |
| 2024 | 3 | 100 | 0 | 206 |
| 2025 | 6 | 58 | 0 | 153 |
| 2026 | 4 | 169 | 0 | — |
What is it indicated for?
The intended use of the Certex Spinal Fixation System is to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): • Traumatic spinal fractures and/or traumatic dislocations; • Instability or deformity; • Failed previous fusions (e.g., pseudoarthrosis); • Tumors involving the…
Read the full statement (177 words)
The intended use of the Certex Spinal Fixation System is to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3):
• Traumatic spinal fractures and/or traumatic dislocations;
• Instability or deformity;
• Failed previous fusions (e.g., pseudoarthrosis);
• Tumors involving the cervical/thoracic spine; and
• Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The X-spine Certex Spinal Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The X-spine Certex Spinal Fixation System can be linked to X-spine Fortex® Pedicle Screw System and X-spine Xpress™ Minimally Invasive Pedicle Screw System with rod-to-rod connectors and transition rods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160428 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160428: Certex Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160428
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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