510(k) · Cleared
ClearedOrthoCircle Spine Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthocircle Spine · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Feb 13, 2020 as substantially equivalent to K171170 (Medacta International S.A., 2017) and 1 other predicate after a 59-day review. Its family tree reaches back 17 generations to 2004. 1 of the 273 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 13, 2020
- Review
- 59 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K040583 (2004). 272 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 273 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations between
- 3 generations backK141988 M.U.S.T Pedicle Screw SystemMedacta International · 2014
- 2 generations backK153664 M.U.S.T. Pedicle Screw SystemMedacta International · 2016
- 1 generation backK171170 M.U.S.T. Pedicle Screw System Extension - Straight Connectors and…Medacta International S.A. · 2017
- This deviceK193472 OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine · 2020
Show all 17 generations
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 14 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 13 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 12 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 11 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 10 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 9 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 8 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 7 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 6 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 5 generations backK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
- 4 generations backK132878 M.U.S.T. ExtensionMedacta International · 2013
- 3 generations backK141988 M.U.S.T Pedicle Screw SystemMedacta International · 2014
- 2 generations backK153664 M.U.S.T. Pedicle Screw SystemMedacta International · 2016
- 1 generation backK171170 M.U.S.T. Pedicle Screw System Extension - Straight Connectors and…Medacta International S.A. · 2017
- This deviceK193472 OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine · 2020
Class I recalls in this family
- K100952 Modification to Synthes Matrix System3 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −14 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −13 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −12 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −11 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −10 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −9 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −8 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −7 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −6 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −5 | K121115 | M.U.S.T Pedicle Screw System | Medacta International | 2012 | 1 |
| −4 | K132878 | M.U.S.T. Extension | Medacta International | 2013 | — |
| −3 | K141988 | M.U.S.T Pedicle Screw System | Medacta International | 2014 | — |
| −2 | K153664 | M.U.S.T. Pedicle Screw System | Medacta International | 2016 | — |
| −1 | K171170 | M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional… | Medacta International S.A. | 2017 | — |
| 0 (this device) | K193472 | OrthoCircle Spine Pedicle Screw System | Orthocircle Spine | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 9 | 0 |
| 1997 | 6 | 0 |
| 1998 | 16 | 0 |
| 1999 | 8 | 0 |
| 2000 | 18 | 0 |
| 2001 | 19 | 0 |
| 2002 | 20 | 0 |
| 2003 | 20 | 0 |
| 2004 | 23 | 0 |
| 2005 | 17 | 0 |
| 2006 | 13 | 0 |
| 2007 | 9 | 0 |
| 2008 | 14 | 0 |
| 2009 | 8 | 0 |
| 2010 | 10 | 1 |
| 2011 | 6 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2019 | 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 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? (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 |
|---|---|---|---|
| * | K171170 | M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsSummary page 5…Trade or Proprietary or Manufacturer Predicate Model Name Type K171170 M.U.S.T. Pedicle Screw System Medacta International SA Primary K191576 Mercury® Spi… | 2017 |
| * | K191576 | Mercury® Spinal System, Overwatch® Spinal SystemSummary page 5…Model Name Type K171170 M.U.S.T. Pedicle Screw System Medacta International SA Primary K191576 Mercury® Spinal System Spinal Elements, Inc. Additional PERFORMANCE DATA The OrthoCircle Spine… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 8 months on median.
- 34 of the 272 ancestors have a recall of any class; 1 has a Class I recall.
- 7 other devices also cite its predicate K171170.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 OrthoCircle Spine Pedicle Screw System is a thoracolumbosacral (T1-S1) spinal fixation system containing devices intended for use as a posterior pedicle screw fixation system. Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all the following indications: degenerative disc disease (defined as discogenic back pain 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, and/or failed previous fusion (pseudoarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193472 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193472: OrthoCircle Spine Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193472
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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