510(k) · Cleared
ClearedSAGICO OSI Spinal System by Osimplant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Analytics & Geometrical Implant Co, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on May 21, 2018 as substantially equivalent to K113666 (Stryker Spine, 2012) and 4 other predicates after a 116-day review. Its family tree reaches back 7 generations to 1995. 1 later device descends from it.
- Decided
- May 21, 2018
- Review
- 116 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K950697 (1995). 45 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 6 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 5 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 4 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 3 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 2 generations backK071373 Stryker Spine Xia Iii Spinal SystemStryker Spine · 2007 · Recalled
- 1 generation backK113666 Xia 3 Spinal SystemStryker Spine · 2012
- This deviceK180220 SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC · 2018
- Descendant · cites it directly · 0 of its ownK232561 Ripley Spinal Screw System by SAGICOSagico VA USA, LLC · 2023
Most influential descendants
Showing 1 of 1 · See all- K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −6 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −5 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −4 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −3 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −2 | K071373 | Stryker Spine Xia Iii Spinal System | Stryker Spine | 2007 | 1 |
| −1 | K113666 | Xia 3 Spinal System | Stryker Spine | 2012 | — |
| 0 (this device) | K180220 | SAGICO OSI Spinal System by Osimplant | Spinal Analytics & Geometrical Implant Co, LLC | 2018 | — |
| +1 | K232561 | Ripley Spinal Screw System by SAGICO | Sagico VA USA, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K113666 | Xia 3 Spinal SystemSummary page 4…May 18th, 2018 Predicate Devices The subject device is substantially equivalent to the primary predicate device XIA® 3 Spinal System – Stryker Spine (K113666) and additional predicate devices, USS Small Stature System - Synthes Spine Medtronic Spine (K071373), CD HORIZON Spinal System -… | 2012 |
| * | K071373 | Stryker Spine Xia Iii Spinal SystemSummary page 4…o the primary predicate device XIA® 3 Spinal System – Stryker Spine (K113666) and additional predicate devices, USS Small Stature System - Synthes Spine Medtronic Spine (K071373), CD HORIZON Spinal System - Sofamor Danek USA (K091445), TSRH Spinal System - Sofamor Danek USA (K994121), XIA 3 Spinal System -… | 2007 |
| * | K091445 | CD Horizon Spinal SystemSummary page 4…ryker Spine (K113666) and additional predicate devices, USS Small Stature System - Synthes Spine Medtronic Spine (K071373), CD HORIZON Spinal System - Sofamor Danek USA (K091445), TSRH Spinal System - Sofamor Danek USA (K994121), XIA 3 Spinal System - Stryker Spine (K111492) Purpose: The purpose of this s… | 2010 |
| * | K994121 | Small Stature UssSummary page 4…ices, USS Small Stature System - Synthes Spine Medtronic Spine (K071373), CD HORIZON Spinal System - Sofamor Danek USA (K091445), TSRH Spinal System - Sofamor Danek USA (K994121), XIA 3 Spinal System - Stryker Spine (K111492) Purpose: The purpose of this submission is to request clearance for new system “… | 2000 |
| * | K111492 | Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific InstrumentsSummary page 4…Medtronic Spine (K071373), CD HORIZON Spinal System - Sofamor Danek USA (K091445), TSRH Spinal System - Sofamor Danek USA (K994121), XIA 3 Spinal System - Stryker Spine (K111492) Purpose: The purpose of this submission is to request clearance for new system “SAGICO OSI SPINAL SYSTEM by Osimplant”. Device… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232561 | Ripley Spinal Screw System by SAGICO | 2023 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 45 ancestors have a recall of any class.
- Of its descendants, K232561 (Sagico VA USA, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 20 other devices also cite its predicate K113666.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The SAGICO OSI SPINAL SYSTEM by Osimplant is intended for use in the non-cervical spine. When used for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the SAGICO OSI SPINAL SYSTEM by Osimplant is intended to provide additional support during fusion using autograft or allograft in Skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: * Degenerative disc…
Read the full statement (172 words)
The SAGICO OSI SPINAL SYSTEM by Osimplant is intended for use in the non-cervical spine.
When used for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the SAGICO OSI SPINAL SYSTEM by Osimplant is intended to provide additional support during fusion using autograft or allograft in Skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
* Degenerative disc disease (DDD) (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
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the SAGICO OSI SPINAL SYSTEM by Osimplant implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis.
The SAGICO OSI SPINAL SYSTEM by Osimplant for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
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/K180220 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180220: SAGICO OSI Spinal System by Osimplant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180220
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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