510(k) · Cleared
Recalled · Class II · 2023INFINITY™ OCT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · NKG Posterior Cervical Screw System
Cleared on Aug 21, 2017 as substantially equivalent to K143471 (Medtronic Sofamor Danek USA, Inc., 2015) and 11 other predicates after a 263-day review. Its family tree reaches back 15 generations to 2004. 16 later devices descend from it. It has been recalled 5 times.
- Decided
- Aug 21, 2017
- Review
- 263 days
- Class
- Class II
- Product code
- NKG
- Recalls
- 5
- Predicates
- 12
Its longest line of descent runs back 15 generations to K040583 (2004). 136 ancestors in all, the oldest K841189 (1984). 16 later devices descend from it, 7 citing it directly.
- Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations between
- 3 generations backK142847 CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2014
- 2 generations backK152457 CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK162379 CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2016
- This deviceK163375 INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2017
- Descendant · cites it directly · 8 of its ownK180851 VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK210449 Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic · 2021
- Descendant · 2 generations on · 3 of its ownK200936 Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK192646 SYMPHONY™ OCT SystemMedos International SARL · 2020
- Descendant · 3 generations on · 1 of its ownK252597 Valence Robotic Navigation System; Valence Robotic Navigation…Alphatec Spine, Inc. · 2026
Show all 15 generations
- Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 12 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 11 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 10 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 9 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 8 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 7 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 6 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 5 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 4 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 3 generations backK142847 CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2014
- 2 generations backK152457 CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK162379 CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2016
- This deviceK163375 INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2017
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2018 · cites it directly8descendants
- K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic · 2021 · cites it directly3descendants
- K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 2 generations on3descendants
- K192646SYMPHONY™ OCT SystemMedos International SARL · 2020 · 2 generations on2descendants
- K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc. · 2026 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −12 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −11 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −10 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −9 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −8 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −7 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −6 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −5 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −4 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −3 | K142847 | CD HORIZON Spinal System | Medtronic Sofamor Danck USA, Inc. | 2014 | — |
| −2 | K152457 | CD HORIZON Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −1 | K162379 | CD HORIZON® Spinal System | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| 0 (this device) | K163375 | INFINITY™ OCT System | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| +1 | K180851 | VERTEX™ Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| +1 | K210449 | Infinity™ OCT System, PASS OCT® Spinal System | Medtronic | 2021 | — |
| +2 | K200936 | Invictus™ CT Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| +2 | K192646 | SYMPHONY™ OCT System | Medos International SARL | 2020 | — |
| +3 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For… | Alphatec Spine, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 6 | 0 |
| 2001 | 10 | 0 |
| 2002 | 12 | 0 |
| 2003 | 10 | 0 |
| 2004 | 25 | 0 |
| 2005 | 14 | 0 |
| 2006 | 11 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 5 | 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 NKG? 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 NKG device
- #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (12)
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 |
|---|---|---|---|
| * | K143471 | VERTEX Reconstruction SystemSummary page 4…com II. Proprietary Trade Name: INFINITYTM OCT System Classification: Unclassified Product Code: NKG, KWP III. Predicate Device: K143471 VERTEX® Reconstruction System (S.E.02/06/2015) – Primary Predicate K003780 VERTEX® Reconstruction System (S.E. 09/28/2001… | 2015 |
| * | K003780 | Vertex Reconstruction SystemSummary page 4…on: Unclassified Product Code: NKG, KWP III. Predicate Device: K143471 VERTEX® Reconstruction System (S.E.02/06/2015) – Primary Predicate K003780 VERTEX® Reconstruction System (S.E. 09/28/2001)- Additional Predicates: K052734 VERTEX® Reconstruction System (S.E. 10/21… | 2001 |
| * | K052734 | Modification to: Vertex Reconstruction SystemSummary page 4…143471 VERTEX® Reconstruction System (S.E.02/06/2015) – Primary Predicate K003780 VERTEX® Reconstruction System (S.E. 09/28/2001)- Additional Predicates: K052734 VERTEX® Reconstruction System (S.E. 10/21/2005) K070742 VERTEX® Reconstruction System (S.E. 09/14/2007) K071942 V… | 2005 |
| * | K070742 | Modification to Vertex Reconstruction SystemSummary page 4…Predicate K003780 VERTEX® Reconstruction System (S.E. 09/28/2001)- Additional Predicates: K052734 VERTEX® Reconstruction System (S.E. 10/21/2005) K070742 VERTEX® Reconstruction System (S.E. 09/14/2007) K071942 VERTEX® Reconstruction System (S.E. 12/11/2007) K082728 V… | 2007 |
| * | K071942 | Modification to Vertex Reconstruction SystemSummary page 4…/28/2001)- Additional Predicates: K052734 VERTEX® Reconstruction System (S.E. 10/21/2005) K070742 VERTEX® Reconstruction System (S.E. 09/14/2007) K071942 VERTEX® Reconstruction System (S.E. 12/11/2007) K082728 VERTEX® Reconstruction System (S.E. 01/16/2009) K090714 V… | 2007 |
| * | K082728 | Vertex Recontruction System, Vertex Select Reconstruction SystemSummary page 4…truction System (S.E. 10/21/2005) K070742 VERTEX® Reconstruction System (S.E. 09/14/2007) K071942 VERTEX® Reconstruction System (S.E. 12/11/2007) K082728 VERTEX® Reconstruction System (S.E. 01/16/2009) K090714 VERTEX® Reconstruction System (S.E. 04/17/2009) K091365 V… | 2009 |
| * | K090714 | Vertex Reconstruction System, Vertex Select Reconstruction SystemSummary page 4…truction System (S.E. 09/14/2007) K071942 VERTEX® Reconstruction System (S.E. 12/11/2007) K082728 VERTEX® Reconstruction System (S.E. 01/16/2009) K090714 VERTEX® Reconstruction System (S.E. 04/17/2009) K091365 VERTEX® Reconstruction System (S.E. 08/06/2009) K123656 V… | 2009 |
| * | K091365 | Vertex Reconstruction System, Vertex Select Reconstruction SystemSummary page 4…truction System (S.E. 12/11/2007) K082728 VERTEX® Reconstruction System (S.E. 01/16/2009) K090714 VERTEX® Reconstruction System (S.E. 04/17/2009) K091365 VERTEX® Reconstruction System (S.E. 08/06/2009) K123656 VERTEX® Reconstruction System (S.E. 02/25/2013) K123906 V… | 2009 |
| * | K123656 | Vertex Reconstruction System, Vertex Select Reconstruction SystemSummary page 4…truction System (S.E. 01/16/2009) K090714 VERTEX® Reconstruction System (S.E. 04/17/2009) K091365 VERTEX® Reconstruction System (S.E. 08/06/2009) K123656 VERTEX® Reconstruction System (S.E. 02/25/2013) K123906 VERTEX® Reconstruction System (S.E. 04/01/2013) K152338 V… | 2013 |
| * | K123906 | Vertex Reconstruction System, Vertext Select Reconstruction SystemSummary page 4…truction System (S.E. 04/17/2009) K091365 VERTEX® Reconstruction System (S.E. 08/06/2009) K123656 VERTEX® Reconstruction System (S.E. 02/25/2013) K123906 VERTEX® Reconstruction System (S.E. 04/01/2013) K152338 VERTEX® Reconstruction System (S.E.10/28/2015) K162379 CD… | 2013 |
| * | K152338 | VERTEX (r) Reconstruction SystemSummary page 4…truction System (S.E. 08/06/2009) K123656 VERTEX® Reconstruction System (S.E. 02/25/2013) K123906 VERTEX® Reconstruction System (S.E. 04/01/2013) K152338 VERTEX® Reconstruction System (S.E.10/28/2015) K162379 CD Horizon® Spinal System (S.E. 11/16/2016) These predicat… | 2015 |
| * | K162379 | CD HORIZON® Spinal SystemSummary page 4…struction System (S.E. 02/25/2013) K123906 VERTEX® Reconstruction System (S.E. 04/01/2013) K152338 VERTEX® Reconstruction System (S.E.10/28/2015) K162379 CD Horizon® Spinal System (S.E. 11/16/2016) These predicates have not been subject to a design-related recall. No… | 2016 |
What descends from it? (16)
See all 167 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180851 | VERTEX™ Reconstruction System | 2018 | 8 |
| K210449 | Infinity™ OCT System, PASS OCT® Spinal System | 2021 | 3 |
| K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw… | 2026 | 0 |
| K254165 | Infinity™ OCT System | 2026 | 0 |
| K253129 | Infinity™ OCT System | 2025 | 0 |
| K223764 | INFINITY OCT System | 2023 | 0 |
| K220810 | Infinity™ OCT System and PASS OCT Spinal System | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 16, 2023 | Class II | Z-1413-2023 | Under Investigation by firm | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws |
| Feb 16, 2023 | Class II | Z-1412-2023 | Under Investigation by firm | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws |
| Feb 16, 2023 | Class II | Z-1410-2023 | Under Investigation by firm | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws |
| Feb 16, 2023 | Class II | Z-1409-2023 | Under Investigation by firm | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws |
| Feb 16, 2023 | Class II | Z-1411-2023 | Under Investigation by firm | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 5 months on median.
- 14 of the 136 ancestors have a recall of any class.
- Of its descendants, K180851 (Medtronic Sofamor Danek USA, Inc., 2018) has gone furthest, with 8 descendants of its own.
- 18 other devices also cite its predicate K143471.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · NKG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKG
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKG
153in 2025
MAUDE reports naming product code NKG, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 17 | 71 | 0 | 4 |
| 2016 | 16 | 87 | 0 | 73 |
| 2017 | 15 | 108 | 0 | 99 |
| 2018 | 12 | 61 | 1 | 127 |
| 2019 | 8 | 50 | 1 | 214 |
| 2020 | 14 | 59 | 2 | 236 |
| 2021 | 7 | 56 | 0 | 704 |
| 2022 | 7 | 108 | 0 | 175 |
| 2023 | 10 | 58 | 0 | 131 |
| 2024 | 3 | 100 | 0 | 206 |
| 2025 | 6 | 58 | 0 | 153 |
| 2026 | 4 | 169 | 0 | — |
What is it indicated for?
The INFINITY™ OCT 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 craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3: • Traumatic spinal fractures and/or traumatic dislocations. • Instability or deformity. • Failed previous fusions (e.g. pseudarthrosis). • Tumors involving the cervical spine. •…
Read the full statement (290 words)
The INFINITY™ OCT 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 craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3:
• Traumatic spinal fractures and/or traumatic dislocations.
• Instability or deformity.
• Failed previous fusions (e.g. pseudarthrosis).
• Tumors involving the cervical spine.
• 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 INFINITY™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the INFINITY™ OCT System may be connected to the CD HORIZON® Spinal System and VERTEX Reconstruction System rods with the INFINITY™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the INFINITY™ OCT System to the CD HORIZON® Spinal System. Refer to the CD HORIZON® Spinal System package insert and VERTEX Reconstruction System package insert for a list of the indications of use.
Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK® at each level in which the 3.0mm screw is intended to be used.
The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.
Note: Segmental fixation is recommended for these constructs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163375 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163375: INFINITY™ OCT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163375
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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