510(k) · Cleared
Recalled · Class II · 2016Overwatch Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amendia, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 13, 2016 as substantially equivalent to K151488 (Orthofix, Inc., 2015) and 2 other predicates after a 100-day review. Its family tree reaches back 15 generations to 2004. 6 later devices descend from it. It has been recalled once.
- Decided
- Oct 13, 2016
- Review
- 100 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 15 generations to K040583 (2004). 237 ancestors in all, the oldest K781443 (1978). 6 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations between
- 3 generations backK121630 Range Spinal SystemK2m, Inc. · 2012
- 2 generations backK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
- 1 generation backK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
- This deviceK161842 Overwatch Spine SystemAmendia, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK191576 Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc. · 2019
- Descendant · 2 generations on · 3 of its ownK222516 Mercury® II Spinal SystemSpinal Elements, Inc. · 2022
- Descendant · 3 generations on · 2 of its ownK243916 Primus Spinal Fixation SystemSpinal Elements, Inc. · 2025
- Descendant · 4 generations on · 1 of its ownK251154 RIVA Posterior Fixation System; RIVA Posterior Fixation System…Ht Medical D.B.A. Xenix Medical · 2025
- Descendant · 5 generations on · 0 of its ownK262193 RIVA® Posterior Fixation System with NanoACTIV Surface Technology…Xenix Medical · 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 backK121630 Range Spinal SystemK2m, Inc. · 2012
- 2 generations backK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
- 1 generation backK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
- This deviceK161842 Overwatch Spine SystemAmendia, Inc. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc. · 2019 · cites it directly5descendants
- K222516Mercury® II Spinal SystemSpinal Elements, Inc. · 2022 · 2 generations on3descendants
- K243916Primus Spinal Fixation SystemSpinal Elements, Inc. · 2025 · 3 generations on2descendants
- K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical · 2025 · 4 generations on1descendant
- K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical · 2026 · 5 generations on0descendants
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 | K121630 | Range Spinal System | K2m, Inc. | 2012 | — |
| −2 | K130932 | Firebird Spinal Fixation System | Orthofix, Inc. | 2013 | 1 |
| −1 | K151488 | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2015 | 1 |
| 0 (this device) | K161842 | Overwatch Spine System | Amendia, Inc. | 2016 | — |
| +1 | K191576 | Mercury® Spinal System, Overwatch® Spinal System | Spinal Elements, Inc. | 2019 | — |
| +2 | K222516 | Mercury® II Spinal System | Spinal Elements, Inc. | 2022 | — |
| +3 | K243916 | Primus Spinal Fixation System | Spinal Elements, Inc. | 2025 | — |
| +4 | K251154 | RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation… | Ht Medical D.B.A. Xenix Medical | 2025 | — |
| +5 | K262193 | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA®… | Xenix Medical | 2026 | — |
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 | 15 | 0 |
| 1999 | 6 | 0 |
| 2000 | 16 | 0 |
| 2001 | 19 | 0 |
| 2002 | 17 | 0 |
| 2003 | 17 | 0 |
| 2004 | 21 | 0 |
| 2005 | 17 | 0 |
| 2006 | 12 | 0 |
| 2007 | 5 | 0 |
| 2008 | 13 | 0 |
| 2009 | 4 | 0 |
| 2010 | 7 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K151488 | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemSummary page 4…erlaminal Fixation Orthosis Primary Predicate Device: Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K151488) Additional Predicate Devices: CD HORIZON Spinal System (K153589) Savannah-T Pedicle Sc… | 2015 |
| * | K153589 | CD HORIZON Spinal SystemSummary page 4…ird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K151488) Additional Predicate Devices: CD HORIZON Spinal System (K153589) Savannah-T Pedicle Screw System (K132925)… | 2016 |
| * | K132925 | Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T…Summary page 4…Fixation System (K151488) Additional Predicate Devices: CD HORIZON Spinal System (K153589) Savannah-T Pedicle Screw System (K132925) K161842… | 2014 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191576 | Mercury® Spinal System, Overwatch® Spinal System | 2019 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 22, 2016 | Class II | Z-0883-2017 | Employee error | The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 6 companies; a new generation was cleared every 5 months on median.
- 28 of the 237 ancestors have a recall of any class.
- Of its descendants, K191576 (Spinal Elements, Inc., 2019) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K151488.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Overwatch Spine System is intended for non-cervical pedicle and non-pedical fixation (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion for the following instabilities/deformities in the thoracolumbar and sacral spine: a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) b) spondylolisthesis, c) trauma (i.e., fracture or dislocation), d) spinal…
Read the full statement (175 words)
The Overwatch Spine System is intended for non-cervical pedicle and non-pedical fixation (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion for the following instabilities/deformities in the thoracolumbar and sacral spine:
a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
b) spondylolisthesis,
c) trauma (i.e., fracture or dislocation),
d) spinal stenosis,
e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
f) tumor,
g) pseudoarthrosis, and
h) failed previous fusion
The Overwatch Spine System is intended for the following indications when used in a posterior percutaneous approach for non-cervical pedicle and non-pedical fixation: Degenerative disc disease; spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion
When used for posterior non-cervical pedicle screw fixation in pediatric patients the Overwatch Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161842: Overwatch Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161842
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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