510(k) · Cleared
ClearedCore Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Core-Nexus · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Aug 9, 2013 as substantially equivalent to K113324 (Dio Medical Co., Ltd., 2012) and 2 other predicates after a 73-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Aug 9, 2013
- Review
- 73 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K000319 (2000). 20 ancestors in all, the oldest K884263 (1988). No later device cites it as a predicate yet.
- Root · 6 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 5 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 4 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 3 generations backK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
- 2 generations backK100765 Fixpine II SystemDio Medical Co., Ltd. · 2010
- 1 generation backK111362 Rexious Spinal Fixation SystemDio Medical Co., Ltd. · 2011
- This deviceK131522 Core Pedicle Screw SystemCore-Nexus · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −5 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −4 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −3 | K053573 | GSS Pedicle Screw System | GS Medical Co., Ltd. | 2006 | — |
| −2 | K100765 | Fixpine II System | Dio Medical Co., Ltd. | 2010 | — |
| −1 | K111362 | Rexious Spinal Fixation System | Dio Medical Co., Ltd. | 2011 | — |
| 0 (this device) | K131522 | Core Pedicle Screw System | Core-Nexus | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 4 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K113324 | Rexious Hook Fixation SystemsSummary page 1…stem PROPRIETARY NAME Core Pedicle Screw System IDENTIFICATION OF PREDICATE DEVICE(S) Dio Medical Rexious Spinal Fixation System (K1 13324, K111362,1K100765)… | 2012 |
| * | K111362 | Rexious Spinal Fixation SystemSummary page 1…e Pedicle Screw System IDENTIFICATION OF PREDICATE DEVICE(S) Dio Medical Rexious Spinal Fixation System (K1 13324, K111362,1K100765) K(131522 - Page 2 of 2… | 2011 |
| * | K100765 | Fixpine II SystemSummary page 1…Screw System IDENTIFICATION OF PREDICATE DEVICE(S) Dio Medical Rexious Spinal Fixation System (K1 13324, K111362,1K100765) K(131522 - Page 2 of 2 DEVICE… | 2010 |
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 13 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 20 ancestors have a recall of any class.
- 2 other devices also cite its predicate K113324.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Care Pedicle Screw System is a posterior pedicle screw system indicated for the treatment of severe spandylolisthesis (Grade 3 and 4) at the L5-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal at the implants after the attainment af a solid fusion. In addition, the Core Pedicle Screw System Is intended to provide Immobilization and…
Read the full statement (194 words)
The Care Pedicle Screw System is a posterior pedicle screw system indicated for the treatment of severe spandylolisthesis (Grade 3 and 4) at the L5-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal at the implants after the attainment af a solid fusion.
In addition, the Core Pedicle Screw System Is intended to provide Immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities at the thoracic lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosls).
The Core Hook System is intended for use as a posterior, noncervical, nonpedicle system indicated for degenerative disc disease (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. The Care Hook System can be used in conjunction with Core Pedicle Screw System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131522: Core Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131522
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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