510(k) Report

510(k) · Cleared

Cleared

Mercury® II Spinal System

K222516510(k) TraditionalCleared Dec 1, 2022104-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spinal Elements, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Dec 1, 2022 as substantially equivalent to K191576 (Spinal Elements, Inc., 2019) and 7 other predicates after a 104-day review. Its family tree reaches back 18 generations to 2004. 3 later devices descend from it.

Decided
Dec 1, 2022
Review
104 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
8

Its longest line of descent runs back 18 generations to K040583 (2004). 336 ancestors in all, the oldest K781443 (1978). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2019: 2 other ancestors2018: 1 other ancestor2015: 5 other ancestors2014: 7 other ancestors2009: 6 other ancestors2008: 17 other ancestors2016: 4 other ancestors2007: 6 other ancestors2006: 17 other ancestors2003: 20 other ancestors2000: 22 other ancestors1999: 8 other ancestors2013: 3 other ancestors2012: 6 other ancestors2011: 8 other ancestors2005: 22 other ancestors2004: 26 other ancestors2002: 22 other ancestors2001: 23 other ancestors1998: 20 other ancestors1997: 11 other ancestors1996: 10 other ancestors2010: 8 other ancestors1995: 15 other ancestors1994: 7 other ancestors1984: 2 other ancestors1988: 2 other ancestors1987: 1 other ancestor1992: 7 other ancestors1989: 1 other ancestor1986: 2 other ancestors1978: 1 other ancestor1985: 1 other ancestor1990: 3 other ancestors1993: 2 other ancestors2025: 2 descendants cleared2026: 1 descendant cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) K121630 · Range Spinal System · K2m, Inc. · 2012K130932 · Firebird Spinal Fixation System · Orthofix, Inc. · 2013 · recalledK151488 · Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System · Orthofix, Inc. · 2015 · recalledK153428 · Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System · Orthofix, Inc. · 2016 · recalledK171082 · Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System · Orthofix, Inc. · 2017 · recalledK180179 · Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw · Orthofix, Inc. · 201819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 14 other ancestors3 generations back: 38 other ancestors4 generations back: 57 other ancestors5 generations back: 56 other ancestors6 generations back: 46 other ancestors7 generations back: 36 other ancestors8 generations back: 26 other ancestors9 generations back: 20 other ancestors10 generations back: 16 other ancestors11 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K180179 · Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw · Orthofix, Inc. · 2018K171082 · Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System · Orthofix, Inc. · 2017 · recalledK153428 · Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System · Orthofix, Inc. · 2016 · recalledK151488 · Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System · Orthofix, Inc. · 2015 · recalledK130932 · Firebird Spinal Fixation System · Orthofix, Inc. · 2013 · recalledK121630 · Range Spinal System · K2m, Inc. · 2012K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−15−10−50
  1. Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 14 generations between
  3. 3 generations backK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · Recalled
  4. 2 generations backK171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System…Orthofix, Inc. · 2017 · Recalled
  5. 1 generation backK180179 Firebird® Spinal Fixation Systems: Firebird System; Firebird…Orthofix, Inc. · 2018
  6. This deviceK222516 Mercury® II Spinal SystemSpinal Elements, Inc. · 2022
  7. Descendant · cites it directly · 2 of its ownK243916 Primus Spinal Fixation SystemSpinal Elements, Inc. · 2025
  8. Descendant · 2 generations on · 1 of its ownK251154 RIVA Posterior Fixation System; RIVA Posterior Fixation System…Ht Medical D.B.A. Xenix Medical · 2025
  9. Descendant · 3 generations on · 0 of its ownK262193 RIVA® Posterior Fixation System with NanoACTIV Surface Technology…Xenix Medical · 2026
Show all 18 generations
  1. Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 17 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 16 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 15 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 14 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 13 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 12 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 11 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 10 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 9 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 8 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 7 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 6 generations backK121630 Range Spinal SystemK2m, Inc. · 2012
  14. 5 generations backK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
  15. 4 generations backK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
  16. 3 generations backK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · Recalled
  17. 2 generations backK171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System…Orthofix, Inc. · 2017 · Recalled
  18. 1 generation backK180179 Firebird® Spinal Fixation Systems: Firebird System; Firebird…Orthofix, Inc. · 2018
  19. This deviceK222516 Mercury® II Spinal SystemSpinal Elements, Inc. · 2022

Most influential descendants

Showing 3 of 3 · See all
  • K243916Primus Spinal Fixation SystemSpinal Elements, Inc. · 2025 · cites it directly2descendants
  • K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical · 2025 · 2 generations on1descendant
  • K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−18K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−17K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−16K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−15K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−14K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−13K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−12K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−11K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−10K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−9K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−8K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−7K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−6K121630Range Spinal SystemK2m, Inc.2012—
−5K130932Firebird Spinal Fixation SystemOrthofix, Inc.20131
−4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.20151
−3K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.20161
−2K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS…Orthofix, Inc.20171
−1K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System…Orthofix, Inc.2018—
0 (this device)K222516Mercury® II Spinal SystemSpinal Elements, Inc.2022—
+1K243916Primus Spinal Fixation SystemSpinal Elements, Inc.2025—
+2K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation…Ht Medical D.B.A. Xenix Medical2025—
+3K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA®…Xenix Medical2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198420
198510
198620
198710
198820
198910
199030
199270
199320
199470
1995150
1996100
1997110
1998200
199980
2000220
2001230
2002220
2003200
2004260
2005220
2006170
200760
2008170
200960
201080
201180
201260
201330
201470
201550
201640
201810
201920

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202520
202610
FIG. 1 — Lineage of K222516, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K191576Mercury® Spinal System, Overwatch® Spinal System
Summary page 7
…ons for use, surgical technique, design features and instrumentation to the following predicate devices: • Primary Predicate: Mercury® and Overwatch® Spinal Systems (K191576) • Additional Predicate: Mercury® Spinal System (K083230, K091587, K141372, K151215, and K172967) • Additional Pre…
Spinal Elements, Inc.2019—
*K083230Mercury Spinal System
Summary page 7
…ntation to the following predicate devices: • Primary Predicate: Mercury® and Overwatch® Spinal Systems (K191576) • Additional Predicate: Mercury® Spinal System (K083230, K091587, K141372, K151215, and K172967) • Additional Predicate: Mercury Navigated Instruments (K190881) • Additio…
Spinal Elements, Inc.2008—
*K091587Mercury Spinal System
Summary page 7
…o the following predicate devices: • Primary Predicate: Mercury® and Overwatch® Spinal Systems (K191576) • Additional Predicate: Mercury® Spinal System (K083230, K091587, K141372, K151215, and K172967) • Additional Predicate: Mercury Navigated Instruments (K190881) • Additional Predi…
Spinal Elements, Inc.2009—
*K141372Mercury Spinal System
Summary page 7
…lowing predicate devices: • Primary Predicate: Mercury® and Overwatch® Spinal Systems (K191576) • Additional Predicate: Mercury® Spinal System (K083230, K091587, K141372, K151215, and K172967) • Additional Predicate: Mercury Navigated Instruments (K190881) • Additional Predicate: Jan…
Spinal Elements, Inc.2014—
*K151215Mercury Spinal System
Summary page 7
…devices: • Primary Predicate: Mercury® and Overwatch® Spinal Systems (K191576) • Additional Predicate: Mercury® Spinal System (K083230, K091587, K141372, K151215, and K172967) • Additional Predicate: Mercury Navigated Instruments (K190881) • Additional Predicate: Janus Fenestrated S…
Spinal Elements, Inc.2015—
*K172967Mercury® Spinal System
Summary page 7
…• Primary Predicate: Mercury® and Overwatch® Spinal Systems (K191576) • Additional Predicate: Mercury® Spinal System (K083230, K091587, K141372, K151215, and K172967) • Additional Predicate: Mercury Navigated Instruments (K190881) • Additional Predicate: Janus Fenestrated Screws (K18017…
Spinal Elements, Inc.2018—
*K190881Spinal Elements Navigated Instruments
Summary page 7
…6) • Additional Predicate: Mercury® Spinal System (K083230, K091587, K141372, K151215, and K172967) • Additional Predicate: Mercury Navigated Instruments (K190881) • Additional Predicate: Janus Fenestrated Screws (K180179) Technological Characteristics The subject device was established…
Spinal Elements, Inc.2019—
*K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…
Summary page 7
…K091587, K141372, K151215, and K172967) • Additional Predicate: Mercury Navigated Instruments (K190881) • Additional Predicate: Janus Fenestrated Screws (K180179) Technological Characteristics The subject device was established as substantially equivalent to another predicate device cleare…
Orthofix, Inc.2018—

Also cleared against K191576: 1 other device →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252

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 18 years and passes through 6 companies; a new generation was cleared every 10 months on median.
  • 47 of the 336 ancestors have a recall of any class.
  • Of its descendants, K243916 (Spinal Elements, Inc., 2025) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K191576.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The Mercury® II Spinal System is 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 (T1-S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. This system is intended for anterior/anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the…

Read the full statement (368 words)

The Mercury® II Spinal System is 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 (T1-S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. This system is 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.

The Spinal Elements Mercury II Spinal System may be used in conjunction with the Spinal Elements Overwatch System. In order to achieve additional levels of fixation, the Mercury II 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 II 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 Il and Overwatch implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach.

Spinal Elements’ fenestrated screws are intended to be used with saline or radiopaque dye.

These devices are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Spinal Elements’ Navigated Instruments are intended to be used during the preparation and placement of Spinal Elements’ Mercury® II screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K222516: Mercury® II 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/K222516

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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