510(k) · Cleared
ClearedCertex Spinal Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Spine Systems, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Oct 31, 2012 as substantially equivalent to K050979 (Aesculap, Inc., 2005) and 2 other predicates after a 103-day review. Its family tree reaches back 10 generations to 1985. 2 later devices descend from it.
- Decided
- Oct 31, 2012
- Review
- 103 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K853033 (1985). 39 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 6 generations between
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK062934 SierraSeaspine, Inc. · 2006
- This deviceK122163 Certex Spinal Implant SystemX-Spine Systems, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK133094 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 10 generations
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 9 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 8 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 7 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 6 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 5 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 4 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK062934 SierraSeaspine, Inc. · 2006
- This deviceK122163 Certex Spinal Implant SystemX-Spine Systems, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −9 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −8 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −7 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −6 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −5 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −4 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −3 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −1 | K062934 | Sierra | Seaspine, Inc. | 2006 | — |
| 0 (this device) | K122163 | Certex Spinal Implant System | X-Spine Systems, Inc. | 2012 | — |
| +1 | 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 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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 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
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 |
|---|---|---|---|
| * | K050979 | S4 Spinal SystemSummary page 2…" Anatomical Region " Implant Materials * Product Dimensions * Mechanical Performance PREDICATE DEVICES * Aesculap, Inc. S4 Spinal System (1<050979) * Seaspine, Inc. Sierra System (K062934) * X-spine Fortex Spinal Fixation System (K090224) PERFORMANCE DATA The im… | 2005 |
| * | K062934 | SierraSummary page 2…ls * Product Dimensions * Mechanical Performance PREDICATE DEVICES * Aesculap, Inc. S4 Spinal System (1<050979) * Seaspine, Inc. Sierra System (K062934) * X-spine Fortex Spinal Fixation System (K090224) PERFORMANCE DATA The implant components were tested using the followin… | 2006 |
| * | K090224 | Fortex Pedicle Screw SystemSummary page 2…ance PREDICATE DEVICES * Aesculap, Inc. S4 Spinal System (1<050979) * Seaspine, Inc. Sierra System (K062934) * X-spine Fortex Spinal Fixation System (K090224) PERFORMANCE DATA The implant components were tested using the following standards: ASTM F1717 -Standard Test Met hods for Spi… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 39 ancestors have a recall of any class.
- Of its descendants, K133094 (X-Spine Systems, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 11 other devices also cite its predicate K050979.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 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 Certex Spinal Implant System is to promote fusion of the subaxial cervical spine and cervico-thoracic junction (C3 -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,
" Failed previous fusion,
* Revision of previous cervical spine surgery,
* Spinal tumors.
The use of screws is limited to placement in TI-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122163 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122163: Certex 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/K122163
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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