510(k) · Cleared
ClearedAegis & Aegis II Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corentec Co., Ltd. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Apr 2, 2010 as substantially equivalent to K060361 (Stryker Spine, 2006) and 3 other predicates after a 267-day review. Its family tree reaches back 5 generations to 1995. 3 later devices descend from it.
- Decided
- Apr 2, 2010
- Review
- 267 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K950697 (1995). 28 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 4 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 3 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 2 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 1 generation backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- This deviceK092076 Aegis & Aegis II Spinal SystemCorentec Co., Ltd. · 2010
- Descendant · cites it directly · 1 of its ownK200267 LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK240180 Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK132644 Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod-…Corentec Co., Ltd. · 2013
Most influential descendants
Showing 3 of 3 · See all- K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd. · 2020 · cites it directly1descendant
- K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd. · 2024 · 2 generations on0descendants
- K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −4 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −3 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −2 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −1 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| 0 (this device) | K092076 | Aegis & Aegis II Spinal System | Corentec Co., Ltd. | 2010 | — |
| +1 | K200267 | LOSPA® IS™ Spinal Fixation System | Corentec Co., Ltd. | 2020 | — |
| +2 | K240180 | Orthopeasia Spinal Fixation System | Orthopeasia Co., Ltd. | 2024 | — |
| +1 | K132644 | Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight… | Corentec Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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? (4)
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 |
|---|---|---|---|
| * | K060361 | Xia Spinal System, Xia 4.5 Spinal SystemSummary page 1…tion Code: MVNI, MVNH, KWQ Predicate Devices Predicate Device #11: XIA Spinal System and XIA 4.5 Spinal System (K060361) Predicate Device #2: XIA Titanium and 4.5 Spinal System (K060979) Predicate Device #3: GGS Pedicle S… | 2006 |
| * | K060979 | Xia Titanium and 4.5 Spinal SystemsSummary page 1…: XIA Spinal System and XIA 4.5 Spinal System (K060361) Predicate Device #2: XIA Titanium and 4.5 Spinal System (K060979) Predicate Device #3: GGS Pedicle Screw System (K053573) Predicate Device #4: U & 1,Optima, Spinal… | 2006 |
| * | K053573 | GSS Pedicle Screw SystemSummary page 1…(K060361) Predicate Device #2: XIA Titanium and 4.5 Spinal System (K060979) Predicate Device #3: GGS Pedicle Screw System (K053573) Predicate Device #4: U & 1,Optima, Spinal System (K031 585) Page 1 of… | 2006 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 1…m and 4.5 Spinal System (K060979) Predicate Device #3: GGS Pedicle Screw System (K053573) Predicate Device #4: U & 1,Optima, Spinal System (K031 585) Page 1 of 3 SUBMITTED BY SCHIFF & COMPANY, WEST CALDWELL, NJ 07006… | 2003 |
What descends from it? (3)
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 15 years and passes through 3 companies; a new generation was cleared every 5 months on median.
- 4 of the 28 ancestors have a recall of any class.
- Of its descendants, K200267 (Corentec Co., Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 18 other devices also cite its predicate K060361.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 AEGIS and AEGIS II Spinal Systems are 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 of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L-5-Si vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture…
Read the full statement (136 words)
The AEGIS and AEGIS II Spinal Systems are 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 of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L-5-Si vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system, The AEGIS and AEGIS 11Spinal Systems are indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordlosis, tumor, pseudloarthrosis, or revision of failed fusion attempts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092076 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092076: Aegis & Aegis II Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092076
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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