510(k) · Cleared
ClearedZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aegis Spine · OUR Sacroiliac Joint Fixation
Cleared on Feb 16, 2021 as substantially equivalent to K181600 (L&K BIOMED Co., Ltd., 2018) and 3 other predicates after a 41-day review. Its family tree reaches back 17 generations to 1985. 1 of the 144 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- Feb 16, 2021
- Review
- 41 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 17 generations to K853033 (1985). 133 ancestors in all. 10 later devices descend from it, 6 citing it directly. 1 of the 144 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 13 generations between
- 3 generations backK151755 OASYS (r) SystemStryker Corporation · 2015
- 2 generations backK162136 CastleLoc-S Posterior Cervical Fixation System; LnK Posterior…L&K BIOMED Co., Ltd. · 2016
- 1 generation backK200793 LnK Posterior Cervical Fixation System and CastleLoc-S Posterior…L&K BIOMED Co., Ltd. · 2020
- This deviceK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
- Descendant · cites it directly · 6 of its ownK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK223719 Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK231839 CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate…L&K BIOMED Co., Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK223521 ZESPIN SI Joint Fusion SystemAegis Spine, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK231841 PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd. · 2023
Show all 17 generations
- Root · 17 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 16 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 15 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 14 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 13 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 12 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 11 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 10 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 9 generations backK072568 Modification to Oasys SystemStryker Spine · 2007
- 8 generations backK080143 Modification to Stryker Spine Oasys SystemStryker Spine · 2008
- 7 generations backK093670 Modification to: Oasys SystemStryker Spine · 2010 · Recalled (Class I)
- 6 generations backK111719 Oasys Spinal SystemStryker Spine · 2012
- 5 generations backK142741 OASYS SystemStryker Corporation · 2015
- 4 generations backK150753 OASYS SystemStryker Corporation · 2015
- 3 generations backK151755 OASYS (r) SystemStryker Corporation · 2015
- 2 generations backK162136 CastleLoc-S Posterior Cervical Fixation System; LnK Posterior…L&K BIOMED Co., Ltd. · 2016
- 1 generation backK200793 LnK Posterior Cervical Fixation System and CastleLoc-S Posterior…L&K BIOMED Co., Ltd. · 2020
- This deviceK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K093670 Modification to: Oasys System7 generations back · 2010
Most influential descendants
Showing 5 of 10 · See all- K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc. · 2022 · cites it directly6descendants
- K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023 · cites it directly3descendants
- K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2023 · cites it directly2descendants
- K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc. · 2023 · cites it directly2descendants
- K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd. · 2023 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −16 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −15 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −14 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −13 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −12 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −11 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −10 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −9 | K072568 | Modification to Oasys System | Stryker Spine | 2007 | — |
| −8 | K080143 | Modification to Stryker Spine Oasys System | Stryker Spine | 2008 | — |
| −7 | K093670 | Modification to: Oasys System | Stryker Spine | 2010 | Class I |
| −6 | K111719 | Oasys Spinal System | Stryker Spine | 2012 | — |
| −5 | K142741 | OASYS System | Stryker Corporation | 2015 | — |
| −4 | K150753 | OASYS System | Stryker Corporation | 2015 | — |
| −3 | K151755 | OASYS (r) System | Stryker Corporation | 2015 | — |
| −2 | K162136 | CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical… | L&K BIOMED Co., Ltd. | 2016 | — |
| −1 | K200793 | LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical… | L&K BIOMED Co., Ltd. | 2020 | — |
| 0 (this device) | K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System… | Aegis Spine | 2021 | — |
| +1 | K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon… | Aegis Spine, Inc. | 2022 | — |
| +1 | K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System | Aegis Spine, Inc. | 2023 | — |
| +1 | K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. | 2023 | — |
| +1 | K223521 | ZESPIN SI Joint Fusion System | Aegis Spine, Inc. | 2023 | — |
| +1 | K231841 | PathLoc SI Joint Fusion System | L&K BIOMED Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 4 | 0 |
| 2005 | 7 | 0 |
| 2006 | 10 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 7 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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 OUR device
- #1 K233508 iFuse Bedrock Granite® Implant Systemscore 30.7 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K181600 | PathLoc-SI Joint Fusion SystemSummary page 9…are identical to the predicate devices in all characteristics. Table 5-1 Predicate Devices 510k Number Trade or Proprietary or Manufacturer Predicate Model Name Type K181600 PathLoc-SI Joint Fusion L&K BIOMED CO., Primary System LTD K200793 CastleLoc-S & LnK L&K BIOMED CO., Additional Posterior Cervic… | 2018 |
| * | K200793 | LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemSummary page 9…le 5-1 Predicate Devices 510k Number Trade or Proprietary or Manufacturer Predicate Model Name Type K181600 PathLoc-SI Joint Fusion L&K BIOMED CO., Primary System LTD K200793 CastleLoc-S & LnK L&K BIOMED CO., Additional Posterior Cervical System LTD K190425 CastleLoc-P Anterior L&K BIOMED CO., Addition… | 2020 |
| * | K190425 | CastleLoc-P Anterior Cervical Plate SystemSummary page 9…Model Name Type K181600 PathLoc-SI Joint Fusion L&K BIOMED CO., Primary System LTD K200793 CastleLoc-S & LnK L&K BIOMED CO., Additional Posterior Cervical System LTD K190425 CastleLoc-P Anterior L&K BIOMED CO., Additional Cervical Plate System LTD K192481 AccelFix Lumbar Plate L&K BIOMED CO., Addition… | 2019 |
| * | K192481 | AccelFix Lumbar Plate SystemSummary page 9…D K200793 CastleLoc-S & LnK L&K BIOMED CO., Additional Posterior Cervical System LTD K190425 CastleLoc-P Anterior L&K BIOMED CO., Additional Cervical Plate System LTD K192481 AccelFix Lumbar Plate L&K BIOMED CO., Additional System LTD PERFORMANCE DATA The ZESPIN SI Joint Fusion System, MegaCerfix Post… | 2020 |
What descends from it? (10)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior… | 2022 | 6 |
| K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System | 2023 | 3 |
| K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System | 2023 | 2 |
| K223521 | ZESPIN SI Joint Fusion System | 2023 | 2 |
| K231841 | PathLoc SI Joint Fusion System | 2023 | 1 |
| K231840 | CastleLoc-S Posterior Cervical Fixation System | 2023 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K093670Modification to: Oasys SystemStryker Spine · 2010 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- 14 of the 133 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K221050 (Aegis Spine, Inc., 2022) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K181600.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · OUR
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OUR
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OUR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OUR
10in 2025
MAUDE reports naming product code OUR, 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 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 3 | 27 | 0 | 6 |
| 2012 | 2 | — | 0 | 81 |
| 2013 | 4 | 103 | 0 | 96 |
| 2014 | 3 | 91 | 0 | 146 |
| 2015 | 8 | 111 | 0 | 119 |
| 2016 | 6 | 168 | 0 | 122 |
| 2017 | 4 | 120 | 0 | 157 |
| 2018 | 7 | 82 | 0 | 137 |
| 2019 | 7 | 89 | 0 | 175 |
| 2020 | 7 | 88 | 0 | 148 |
| 2021 | 9 | 85 | 0 | 154 |
| 2022 | 14 | 149 | 0 | 23 |
| 2023 | 20 | 55 | 0 | 7 |
| 2024 | 15 | 74 | 0 | 15 |
| 2025 | 14 | 97 | 1 | 10 |
| 2026 | 6 | 98 | 1 | — |
What is it indicated for?
The ZESPIN SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The MegaCerfix Posterior Cervical Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or…
Read the full statement (354 words)
The ZESPIN SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The MegaCerfix Posterior Cervical Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of 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 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 MegaCerfix Posterior Cervical 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 MegaCerfix Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:
x degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
x spondylolisthesis,
x trauma (i.e. fractures or dislocations),
x tumors,
x deformity (defined as kyphosis, lordosis, or scoliosis),
x pseudoarthrosis,
x failed previous fusion,
x spinal stenosis.
The Spinema Lumbar Plate System is indicated for use via the anterior, lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scolosis, spondylolisthesis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210035 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210035: ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210035
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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