510(k) Report

510(k) · Cleared

Cleared

Valeo Pedicle Screw Spinal System

K072022510(k) TraditionalCleared Nov 19, 2007119-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

Amedica Corp. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Nov 19, 2007 as substantially equivalent to K973836 (Cross Medical Products, Inc., 1998) and 9 other predicates after a 119-day review. Its family tree reaches back 4 generations to 2000. 100 later devices descend from it.

Decided
Nov 19, 2007
Review
119 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
10

Its longest line of descent runs back 4 generations to K000319 (2000). 32 ancestors in all, the oldest K901587 (1990). 100 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2004: 2 other ancestors2003: 2 other ancestors1999: 3 other ancestors1998: 2 other ancestors1997: 2 other ancestors2002: 1 other ancestor2000: 3 other ancestors1995: 2 other ancestors1994: 1 other ancestor1993: 2 other ancestors1992: 5 other ancestors1990: 2 other ancestors2021: 7 descendants cleared2012: 4 descendants cleared2014: 6 descendants cleared2013: 3 descendants cleared2016: 6 descendants cleared2008: 2 descendants cleared2017: 3 descendants cleared2024: 12 descendants cleared2020: 13 descendants cleared2026: 11 descendants cleared2019: 4 descendants cleared2023: 12 descendants cleared2009: 1 descendant cleared2015: 3 descendants cleared2022: 5 descendants cleared2018: 3 descendants cleared2025: 5 descendants clearedK000319 · Ebi Xfix DFS System · Ebi, L.P. · 2000K020279 · Forex Corporation, Optima, Spinal System · Forex Corp. · 2002 · recalledK024096 · Optima, Spinal System · U&I Corp., America · 2003 · recalledK071857 · Delta Spinal Fusion System · Jemo Spine, LLC · 20071990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 9 other ancestors3 generations back: 11 other ancestors 1 generation forward: 7 descendants2 generations forward: 19 descendants3 generations forward: 26 descendants4 generations forward: 23 descendants5 generations forward: 16 descendants6 generations forward: 7 descendants7 generations forward: 1 descendant8 generations forward: 1 descendant K071857 · Delta Spinal Fusion System · Jemo Spine, LLC · 2007K024096 · Optima, Spinal System · U&I Corp., America · 2003 · recalledK020279 · Forex Corporation, Optima, Spinal System · Forex Corp. · 2002 · recalledK000319 · Ebi Xfix DFS System · Ebi, L.P. · 20000+5
  1. Root · 4 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
  2. 3 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
  3. 2 generations backK024096 Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
  4. 1 generation backK071857 Delta Spinal Fusion SystemJemo Spine, LLC · 2007
  5. This deviceK072022 Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2007
  6. Descendant · cites it directly · 43 of its ownK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
  7. Descendant · cites it directly · 30 of its ownK151977 icotec Pedicle SystemIcotec AG · 2016
  8. Descendant · 2 generations on · 29 of its ownK190545 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · Recalled
  9. Descendant · cites it directly · 28 of its ownK132878 M.U.S.T. ExtensionMedacta International · 2013
  10. Descendant · 2 generations on · 27 of its ownK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled

Showing 5 of 100 descendants. See all descendants

Descendants cleared per year

2008: 22009: 12012: 42013: 32014: 62015: 32016: 62017: 32018: 32019: 42020: 132021: 72022: 52023: 122024: 122025: 52026: 11
2008high 13 (2020) · low 0 (2010)2026

Most influential descendants

Showing 5 of 100 · See all
  • K121115M.U.S.T Pedicle Screw SystemMedacta International · 2012 · cites it directly43descendants
  • K151977icotec Pedicle SystemIcotec AG · 2016 · cites it directly30descendants
  • K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · 2 generations on29descendants
  • K132878M.U.S.T. ExtensionMedacta International · 2013 · cites it directly28descendants
  • K200596G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · 2 generations on27descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K000319Ebi Xfix DFS SystemEbi, L.P.2000—
−3K020279Forex Corporation, Optima, Spinal SystemForex Corp.20024
−2K024096Optima, Spinal SystemU&I Corp., America20033
−1K071857Delta Spinal Fusion SystemJemo Spine, LLC2007—
0 (this device)K072022Valeo Pedicle Screw Spinal SystemAmedica Corp.2007—
+1K121115M.U.S.T Pedicle Screw SystemMedacta International20121
+1K151977icotec Pedicle SystemIcotec AG2016—
+2K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG20191
+1K132878M.U.S.T. ExtensionMedacta International2013—
+2K200596G21 Cement, VADER® Pedicle SystemIcotec AG20201

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199020
199250
199320
199410
199520
199720
199820
199930
200030
200210
200320
200420
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
200910
201240
201330
201460
201530
201660
201730
201830
201940
2020130
202170
202250
2023120
2024120
202550
2026110
FIG. 1 — Lineage of K072022, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (10)

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
*K973836Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy…
Summary page 2
…cleared devices and has the same indications for use, design, function, and materials used. The cited references include: * Biomet Synergy VLS Open (K973836) * Synthes Pangea (K052123) * Zimmer Silhouette (K993067) * Medtronic Sofamor Danek CD Horizon 3.5mm rods (K042962…
Cross Medical Products, Inc.1998—
*K052123Synthes Pangea System
Summary page 2
…indications for use, design, function, and materials used. The cited references include: * Biomet Synergy VLS Open (K973836) * Synthes Pangea (K052123) * Zimmer Silhouette (K993067) * Medtronic Sofamor Danek CD Horizon 3.5mm rods (K042962) * Medtronic Sofamor Danek…
Synthes (Usa)2005—
*K993067Silhouette Spinal Fixation System
Summary page 2
…ion, and materials used. The cited references include: * Biomet Synergy VLS Open (K973836) * Synthes Pangea (K052123) * Zimmer Silhouette (K993067) * Medtronic Sofamor Danek CD Horizon 3.5mm rods (K042962) * Medtronic Sofamor Danek EQUATIONT M Fixation System (K0334…
Sulzer Spine-Tech1999—
*K042962Modification to CD Horizon Spinal System
Summary page 2
…e 2 === * Biomet Synergy VLS Open (K973836) * Synthes Pangea (K052123) * Zimmer Silhouette (K993067) * Medtronic Sofamor Danek CD Horizon 3.5mm rods (K042962) * Medtronic Sofamor Danek EQUATIONT M Fixation System (K033495, K042453) * U&I Corp Optima Spinal System (K024096, K03…
Medtronic Sofamor Danek2004—
*K033495Modification to Equation Fixation System
Summary page 2
…a (K052123) * Zimmer Silhouette (K993067) * Medtronic Sofamor Danek CD Horizon 3.5mm rods (K042962) * Medtronic Sofamor Danek EQUATIONT M Fixation System (K033495, K042453) * U&I Corp Optima Spinal System (K024096, K031585) • DePuy Spine MOSS Miami 4.0 Spinal System (K962628) *…
Medtronic Sofamor Danek, Inc.2003—
*K042453Modification to Equation Fixation System
Summary page 2
…3) * Zimmer Silhouette (K993067) * Medtronic Sofamor Danek CD Horizon 3.5mm rods (K042962) * Medtronic Sofamor Danek EQUATIONT M Fixation System (K033495, K042453) * U&I Corp Optima Spinal System (K024096, K031585) • DePuy Spine MOSS Miami 4.0 Spinal System (K962628) * Jemo Sp…
Medtronic Sofamor Danek, Inc.2004—
*K024096Optima, Spinal System
Summary page 2
…dtronic Sofamor Danek CD Horizon 3.5mm rods (K042962) * Medtronic Sofamor Danek EQUATIONT M Fixation System (K033495, K042453) * U&I Corp Optima Spinal System (K024096, K031585) • DePuy Spine MOSS Miami 4.0 Spinal System (K962628) * Jemo Spine DELTATM Spinal Fusion System (K071857) Per…
U&I Corp., America20033
*K031585U&I, Optima, Spinal System
Summary page 2
…ofamor Danek CD Horizon 3.5mm rods (K042962) * Medtronic Sofamor Danek EQUATIONT M Fixation System (K033495, K042453) * U&I Corp Optima Spinal System (K024096, K031585) • DePuy Spine MOSS Miami 4.0 Spinal System (K962628) * Jemo Spine DELTATM Spinal Fusion System (K071857) Performance…
U&I Corp., America20035
*K962628Moss Miami Spinal System
Summary page 2
…nic Sofamor Danek EQUATIONT M Fixation System (K033495, K042453) * U&I Corp Optima Spinal System (K024096, K031585) • DePuy Spine MOSS Miami 4.0 Spinal System (K962628) * Jemo Spine DELTATM Spinal Fusion System (K071857) Performance Standards: Testing performed indicates the ValeoTM Pedicl…
Depuy, Inc.1997—
*K071857Delta Spinal Fusion System
Cleared while this submission was under review
Summary page 2
…042453) * U&I Corp Optima Spinal System (K024096, K031585) • DePuy Spine MOSS Miami 4.0 Spinal System (K962628) * Jemo Spine DELTATM Spinal Fusion System (K071857) Performance Standards: Testing performed indicates the ValeoTM Pedicle Screw System is substantially equivalent to predicate d…
Jemo Spine, LLC2007—

Also cleared against K973836: 7 other devices →

What descends from it? (100)

See all 100

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K121115M.U.S.T Pedicle Screw SystemMedacta International201243
K151977icotec Pedicle SystemIcotec AG201630
K132878M.U.S.T. ExtensionMedacta International201328
K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824
K141044M.U.S.T. ExtensionMedacta International201416
K113625DSS Stabilization SystemParadigm Spine, LLC20121
K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210

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 7 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
  • 4 of the 32 ancestors have a recall of any class.
  • Of its descendants, K121115 (Medacta International, 2012) has gone furthest, with 43 descendants of its own.
  • 7 other devices also cite its predicate K973836.

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. 2007, 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 ValeoTM Pedicle Screw System is intended for noncervical pedicle fixation from the TI to L5 vertebrae in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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; pseudarthrosis; and failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K973836

7 other devices cite the same predicate.

  • K181995Chiral Surgical Pedicle Screw SystemChiral Surgical · 2018
  • K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd. · 2017
  • K112684Mont Blanc Pedicle Screw SystemsQualgenix · 2012
  • K080241DDS Stabilization SystemParadigm Spine, LLC · 2008
  • K980484Aesculap Spine System EvolutionAesculap, Inc. · 1998
  • K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc. · 1998

More from Amedica Corp.

16 FDA decisions under this applicant name. See the company

  • K173453Valeo® C+CSC with Lumen Interbody Fusion DeviceAmedica Corp. · 2018
  • K161405Valeo II Interbody Fusion Device SystemAmedica Corp. · 2016
  • K143518Valeo Spacer System and Valeo II Interbody Fusion Device SystemAmedica Corp. · 2015
  • K142264Valeo C Spacer System, Valeo II C IBF DeviceAmedica Corp. · 2014
  • K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp. · 2014

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K072022 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072022: Valeo Pedicle Screw Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072022

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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