510(k) · Cleared
ClearedZESPIN SI Joint Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aegis Spine, Inc. · OUR Sacroiliac Joint Fixation
Cleared on Jan 20, 2023 as substantially equivalent to K210035 (Aegis Spine, 2021) and 1 other predicate after a 58-day review. Its family tree reaches back 18 generations to 1985. 1 of the 153 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Jan 20, 2023
- Review
- 58 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K853033 (1985). 150 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 153 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 14 generations between
- 3 generations backK162136 CastleLoc-S Posterior Cervical Fixation System; LnK Posterior…L&K BIOMED Co., Ltd. · 2016
- 2 generations backK200793 LnK Posterior Cervical Fixation System and CastleLoc-S Posterior…L&K BIOMED Co., Ltd. · 2020
- 1 generation backK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
- This deviceK223521 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
- Descendant · 2 generations on · 0 of its ownK240201 PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd. · 2024
Show all 18 generations
- Root · 18 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 17 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 16 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 15 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 14 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 13 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 12 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 11 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 10 generations backK072568 Modification to Oasys SystemStryker Spine · 2007
- 9 generations backK080143 Modification to Stryker Spine Oasys SystemStryker Spine · 2008
- 8 generations backK093670 Modification to: Oasys SystemStryker Spine · 2010 · Recalled (Class I)
- 7 generations backK111719 Oasys Spinal SystemStryker Spine · 2012
- 6 generations backK142741 OASYS SystemStryker Corporation · 2015
- 5 generations backK150753 OASYS SystemStryker Corporation · 2015
- 4 generations backK151755 OASYS (r) SystemStryker Corporation · 2015
- 3 generations backK162136 CastleLoc-S Posterior Cervical Fixation System; LnK Posterior…L&K BIOMED Co., Ltd. · 2016
- 2 generations backK200793 LnK Posterior Cervical Fixation System and CastleLoc-S Posterior…L&K BIOMED Co., Ltd. · 2020
- 1 generation backK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
- This deviceK223521 ZESPIN SI Joint Fusion SystemAegis Spine, Inc. · 2023
Class I recalls in this family
- K093670 Modification to: Oasys System8 generations back · 2010
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 |
|---|---|---|---|---|---|
| −18 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −17 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −16 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −15 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −14 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −13 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −12 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −11 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −10 | K072568 | Modification to Oasys System | Stryker Spine | 2007 | — |
| −9 | K080143 | Modification to Stryker Spine Oasys System | Stryker Spine | 2008 | — |
| −8 | K093670 | Modification to: Oasys System | Stryker Spine | 2010 | Class I |
| −7 | K111719 | Oasys Spinal System | Stryker Spine | 2012 | — |
| −6 | K142741 | OASYS System | Stryker Corporation | 2015 | — |
| −5 | K150753 | OASYS System | Stryker Corporation | 2015 | — |
| −4 | K151755 | OASYS (r) System | Stryker Corporation | 2015 | — |
| −3 | K162136 | CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical… | L&K BIOMED Co., Ltd. | 2016 | — |
| −2 | K200793 | LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical… | L&K BIOMED Co., Ltd. | 2020 | — |
| −1 | K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System… | Aegis Spine | 2021 | — |
| 0 (this device) | K223521 | ZESPIN SI Joint Fusion System | Aegis Spine, Inc. | 2023 | — |
| +1 | K231841 | PathLoc SI Joint Fusion System | L&K BIOMED Co., Ltd. | 2023 | — |
| +2 | K240201 | PathLoc SI Joint Fusion System | L&K BIOMED Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 8 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 4 | 0 |
| 2005 | 8 | 0 |
| 2006 | 10 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 7 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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.
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? (2)
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 |
|---|---|---|---|
| * | K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Summary page 4…devices are similar to the predicate devices in all characteristics. Subject Device Name | 510K NO. | Trade or Proprietary or Model Name Predicate Type ZESPIN SI Joint K 210035 | ZESPIN SI Joint Fusion System Primary Fusion System K 152237 | Entasis™ Dual-Lead Sacroiliac Implant Additional The design fea… | 2021 |
| * | K152237 | The Entasis Dual-Lead Sacroiliac ImplantSummary page 4…stics. Subject Device Name | 510K NO. | Trade or Proprietary or Model Name Predicate Type ZESPIN SI Joint K 210035 | ZESPIN SI Joint Fusion System Primary Fusion System K 152237 | Entasis™ Dual-Lead Sacroiliac Implant Additional The design feature, indications for use and manufacturing process for the sub… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231841 | PathLoc SI Joint Fusion System | 2023 | 1 |
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 · 8 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 38 years and passes through 10 companies; a new generation was cleared every 1.3 years on median.
- 16 of the 150 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K231841 (L&K BIOMED Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K210035.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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.
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/K223521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223521: ZESPIN SI Joint Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223521
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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