510(k) · Cleared
ClearedMercury® Spinal System, Overwatch® Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Elements, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 16, 2019 as substantially equivalent to K161842 (Amendia, Inc., 2016) and 4 other predicates after a 94-day review. Its family tree reaches back 16 generations to 2004. 5 later devices descend from it.
- Decided
- Sep 16, 2019
- Review
- 94 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K040583 (2004). 250 ancestors in all, the oldest K781443 (1978). 5 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations between
- 3 generations backK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
- 2 generations backK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
- 1 generation backK161842 Overwatch Spine SystemAmendia, Inc. · 2016 · Recalled
- This deviceK191576 Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK222516 Mercury® II Spinal SystemSpinal Elements, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK243916 Primus Spinal Fixation SystemSpinal Elements, Inc. · 2025
- Descendant · 3 generations on · 1 of its ownK251154 RIVA Posterior Fixation System; RIVA Posterior Fixation System…Ht Medical D.B.A. Xenix Medical · 2025
- Descendant · 4 generations on · 0 of its ownK262193 RIVA® Posterior Fixation System with NanoACTIV Surface Technology…Xenix Medical · 2026
- Descendant · cites it directly · 0 of its ownK193472 OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine · 2020
Show all 16 generations
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 13 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 11 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 10 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 9 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 8 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 7 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 6 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 5 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 4 generations backK121630 Range Spinal SystemK2m, Inc. · 2012
- 3 generations backK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
- 2 generations backK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
- 1 generation backK161842 Overwatch Spine SystemAmendia, Inc. · 2016 · Recalled
- This deviceK191576 Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K222516Mercury® II Spinal SystemSpinal Elements, Inc. · 2022 · cites it directly3descendants
- K243916Primus Spinal Fixation SystemSpinal Elements, Inc. · 2025 · 2 generations on2descendants
- K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical · 2025 · 3 generations on1descendant
- K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical · 2026 · 4 generations on0descendants
- K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −13 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −11 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −10 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −9 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −8 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −7 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −6 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −5 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −4 | K121630 | Range Spinal System | K2m, Inc. | 2012 | — |
| −3 | K130932 | Firebird Spinal Fixation System | Orthofix, Inc. | 2013 | 1 |
| −2 | K151488 | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2015 | 1 |
| −1 | K161842 | Overwatch Spine System | Amendia, Inc. | 2016 | 1 |
| 0 (this device) | K191576 | Mercury® Spinal System, Overwatch® Spinal System | Spinal Elements, Inc. | 2019 | — |
| +1 | K222516 | Mercury® II Spinal System | Spinal Elements, Inc. | 2022 | — |
| +2 | K243916 | Primus Spinal Fixation System | Spinal Elements, Inc. | 2025 | — |
| +3 | K251154 | RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation… | Ht Medical D.B.A. Xenix Medical | 2025 | — |
| +4 | K262193 | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA®… | Xenix Medical | 2026 | — |
| +1 | 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 | 6 | 0 |
| 2000 | 17 | 0 |
| 2001 | 19 | 0 |
| 2002 | 19 | 0 |
| 2003 | 18 | 0 |
| 2004 | 21 | 0 |
| 2005 | 17 | 0 |
| 2006 | 13 | 0 |
| 2007 | 6 | 0 |
| 2008 | 14 | 0 |
| 2009 | 6 | 0 |
| 2010 | 7 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K161842 | Overwatch Spine SystemSummary page 6…lent in indications for use, surgical technique, design features and instrumentation to the following predicate devices: • Primary Predicate: Overwatch Spinal System K161842 • Additional Predicates are for Mercury Spinal System (K083230, K091587, K141372, and K151215) Technological Characte… | 2016 |
| * | K083230 | Mercury Spinal SystemSummary page 6…d instrumentation to the following predicate devices: • Primary Predicate: Overwatch Spinal System K161842 • Additional Predicates are for Mercury Spinal System (K083230, K091587, K141372, and K151215) Technological Characteristics The subject device was established as substantially equival… | 2008 |
| * | K091587 | Mercury Spinal SystemSummary page 6…entation to the following predicate devices: • Primary Predicate: Overwatch Spinal System K161842 • Additional Predicates are for Mercury Spinal System (K083230, K091587, K141372, and K151215) Technological Characteristics The subject device was established as substantially equivalent to an… | 2009 |
| * | K141372 | Mercury Spinal SystemSummary page 6…following predicate devices: • Primary Predicate: Overwatch Spinal System K161842 • Additional Predicates are for Mercury Spinal System (K083230, K091587, K141372, and K151215) Technological Characteristics The subject device was established as substantially equivalent to another predicate… | 2014 |
| * | K151215 | Mercury Spinal SystemSummary page 6…dicate devices: • Primary Predicate: Overwatch Spinal System K161842 • Additional Predicates are for Mercury Spinal System (K083230, K091587, K141372, and K151215) Technological Characteristics The subject device was established as substantially equivalent to another predicate device cleare… | 2015 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 30 of the 250 ancestors have a recall of any class.
- Of its descendants, K222516 (Spinal Elements, Inc., 2022) has gone furthest, with 3 descendants of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Mercury® and Overwatch® Spinal Systems are intended to provide immobilization and stabilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (Tl -S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. These systems are intended for anterior/anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle…
Read the full statement (255 words)
The Mercury® and Overwatch® Spinal Systems are intended to provide immobilization and stabilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (Tl -S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. These systems are intended for anterior/anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: 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.
These systems are intended to be used with bone graft.
The Spinal Elements Mercury Fixation System may be used in conjunction with the Spinal Elements Overwatch System. In order to achieve additional levels of fixation, the Mercury or Overwatch Fixation Systems may be connected to the Lotus Posterior Cervical/Thoracic rod connectors. Transition rods with differing diameters may also be used to connect the Lotus Posterior Cervical/Thoracic Spinal System to the Mercury or Overwatch Spinal Systems. Refer to the Lotus Posterior Cervical/Thoracic Spinal System package insert for a list of Lotus indications for use.
When used for posterior non-cervical pedicle screw fixation in pediatric patients the Mercury and Overwatch 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/K191576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191576: Mercury® Spinal System, Overwatch® Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191576
Report an extraction error
Are you the manufacturer?
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