510(k) Report

510(k) · Cleared

Cleared

Valeo Pedicle Screw Spinal System

K073430510(k) TraditionalCleared Jan 29, 200854-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 Jan 29, 2008 as substantially equivalent to K071857 (Jemo Spine, LLC, 2007) and 11 other predicates after a 54-day review. Its family tree reaches back 10 generations to 1985. 24 later devices descend from it.

Decided
Jan 29, 2008
Review
54 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
12

Its longest line of descent runs back 10 generations to K853033 (1985). 139 ancestors in all. 24 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 8 other ancestors2006: 5 other ancestors2003: 13 other ancestors2005: 10 other ancestors2004: 16 other ancestors2002: 8 other ancestors2001: 9 other ancestors2000: 10 other ancestors1999: 11 other ancestors1998: 11 other ancestors1997: 4 other ancestors1994: 3 other ancestors1996: 4 other ancestors1995: 7 other ancestors1993: 3 other ancestors1992: 5 other ancestors1990: 2 other ancestors2008: 1 descendant cleared2016: 1 descendant cleared2009: 1 descendant cleared2015: 2 descendants cleared2013: 2 descendants cleared2022: 2 descendants cleared2012: 1 descendant cleared2021: 3 descendants cleared2014: 3 descendants cleared2023: 1 descendant cleared2020: 2 descendants cleared2019: 2 descendants cleared2026: 2 descendants cleared2024: 1 descendant clearedK853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004K062174 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K070387 · Expedium Spine System · Depuy Spine, Inc. · 20071990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 11 other ancestors2 generations back: 41 other ancestors3 generations back: 37 other ancestors4 generations back: 24 other ancestors5 generations back: 14 other ancestors6 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 6 descendants3 generations forward: 7 descendants4 generations forward: 5 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant K070387 · Expedium Spine System · Depuy Spine, Inc. · 2007K062174 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985−10−50+5
  1. Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 6 generations between
  3. 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  4. 2 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  5. 1 generation backK070387 Expedium Spine SystemDepuy Spine, Inc. · 2007
  6. This deviceK073430 Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2008
  7. Descendant · cites it directly · 21 of its ownK080767 Conquest Spinal SystemLife Spine · 2008
  8. Descendant · 2 generations on · 17 of its ownK123373 Nautilus Spinal SystemLife Spine · 2013
  9. Descendant · 3 generations on · 14 of its ownK132760 Nautilus Spinal SystemLife Spine, Inc. · 2013
  10. Descendant · 2 generations on · 13 of its ownK141222 Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015
  11. Descendant · 4 generations on · 13 of its ownK133564 Modification to Nautilus Spinal SystemLife Spine, LLC · 2014
Show all 10 generations
  1. Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 9 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 8 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 7 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 6 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 5 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 4 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 2 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  10. 1 generation backK070387 Expedium Spine SystemDepuy Spine, Inc. · 2007
  11. This deviceK073430 Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2008

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12012: 12013: 22014: 32015: 22016: 12019: 22020: 22021: 32022: 22023: 12024: 12026: 2
2008high 3 (2014) · low 0 (2010)2026

Most influential descendants

Showing 5 of 24 · See all
  • K080767Conquest Spinal SystemLife Spine · 2008 · cites it directly21descendants
  • K123373Nautilus Spinal SystemLife Spine · 2013 · 2 generations on17descendants
  • K132760Nautilus Spinal SystemLife Spine, Inc. · 2013 · 3 generations on14descendants
  • K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015 · 2 generations on13descendants
  • K133564Modification to Nautilus Spinal SystemLife Spine, LLC · 2014 · 4 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−9K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−8K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−7K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−6K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−5K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−4K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−3K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−2K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−1K070387Expedium Spine SystemDepuy Spine, Inc.2007—
0 (this device)K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.2008—
+1K080767Conquest Spinal SystemLife Spine2008—
+2K123373Nautilus Spinal SystemLife Spine2013—
+3K132760Nautilus Spinal SystemLife Spine, Inc.2013—
+2K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.2015—
+4K133564Modification to Nautilus Spinal SystemLife Spine, LLC2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199020
199250
199330
199430
199570
199640
199740
1998110
1999110
2000100
200190
200280
2003130
2004160
2005100
200650
200780

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201210
201320
201430
201520
201610
201920
202020
202130
202220
202310
202410
202620
FIG. 1 — Lineage of K073430, 1985–2026Source: 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? (12)

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
*K071857Delta Spinal Fusion System
Summary page 2
…devices and has the same indications for use, design, function, and materials used. The cited references include: * Jemo Spine Delta TM Spinal Fixation System (K071857) * U&I OptimaTM Spinal System (K03.1585) · DePuy Expedium Spine System (K070387) * Medtronic Sofamor Dan…
Jemo Spine, LLC2007—
*K031585U&I, Optima, Spinal SystemU&I Corp., America20035
*K070387Expedium Spine System
Summary page 2
…ferences include: * Jemo Spine Delta TM Spinal Fixation System (K071857) * U&I OptimaTM Spinal System (K03.1585) · DePuy Expedium Spine System (K070387) * Medtronic Sofamor Danek TSRH® Spinal System (K072317) * Zimmer ST360°® Spinal Fixation System (K072183)…
Depuy Spine, Inc.2007—
*K072317Modification to:TSRH Spinal System
Summary page 2
…System (K071857) * U&I OptimaTM Spinal System (K03.1585) · DePuy Expedium Spine System (K070387) * Medtronic Sofamor Danek TSRH® Spinal System (K072317) * Zimmer ST360°® Spinal Fixation System (K072183) * Theken Spine CoralTM Spinal System (K070962) * De…
Medtronic Sofamor Danek USA, Inc.20074
*K072183ST360 Spinal Fixation System, Model 07.0029-7500.5600
Summary page 2
…1585) · DePuy Expedium Spine System (K070387) * Medtronic Sofamor Danek TSRH® Spinal System (K072317) * Zimmer ST360°® Spinal Fixation System (K072183) * Theken Spine CoralTM Spinal System (K070962) * DePuy Spine VIPER Spine System (K071860) · Vertebron…
Zimmer Spine, Inc.2007—
*K070962Coral Pedicle Screw System
Summary page 2
…* Medtronic Sofamor Danek TSRH® Spinal System (K072317) * Zimmer ST360°® Spinal Fixation System (K072183) * Theken Spine CoralTM Spinal System (K070962) * DePuy Spine VIPER Spine System (K071860) · Vertebron PSST M Pedicle Screw System (K071376) * Custom…
Theken Spine, LLC2007—
*K071860Modification to: Viper Spine System
Summary page 2
…m (K072317) * Zimmer ST360°® Spinal Fixation System (K072183) * Theken Spine CoralTM Spinal System (K070962) * DePuy Spine VIPER Spine System (K071860) · Vertebron PSST M Pedicle Screw System (K071376) * Custom Spine ISSYS LP Spinal Fixation System (K070281)…
Depuy Spine, Inc.2007—
*K071376Modification to Vertebron PSS Pedicle Screw System
Summary page 2
…m (K072183) * Theken Spine CoralTM Spinal System (K070962) * DePuy Spine VIPER Spine System (K071860) · Vertebron PSST M Pedicle Screw System (K071376) * Custom Spine ISSYS LP Spinal Fixation System (K070281) * EBI® Array® Spinal System (K062685) * Glob…
Vertebron, Inc.2007—
*K070281Issys LP Spinal Fixation System
Summary page 2
…) * DePuy Spine VIPER Spine System (K071860) · Vertebron PSST M Pedicle Screw System (K071376) * Custom Spine ISSYS LP Spinal Fixation System (K070281) * EBI® Array® Spinal System (K062685) * Globus Medical REVERETM Stabilization System (K061202) * Amed…
Custom Spine, Inc.20071
*K062685Ebi Aray Spinal System
Summary page 2
…71860) · Vertebron PSST M Pedicle Screw System (K071376) * Custom Spine ISSYS LP Spinal Fixation System (K070281) * EBI® Array® Spinal System (K062685) * Globus Medical REVERETM Stabilization System (K061202) * Amedica ValeoTM Pedicle Screw System (K072022) Per…
Ebi, L.P.20061
*K061202Revere Stabilization System
Summary page 2
…* Custom Spine ISSYS LP Spinal Fixation System (K070281) * EBI® Array® Spinal System (K062685) * Globus Medical REVERETM Stabilization System (K061202) * Amedica ValeoTM Pedicle Screw System (K072022) Performance Standards: Testing performed indicates the ValeoTM Pedic…
Globus Medical, Inc.2006—
*K072022Valeo Pedicle Screw Spinal System
Summary page 2
…070281) * EBI® Array® Spinal System (K062685) * Globus Medical REVERETM Stabilization System (K061202) * Amedica ValeoTM Pedicle Screw System (K072022) Performance Standards: Testing performed indicates the ValeoTM Pedicle Screw System is substantially equivalent to predicate d…
Amedica Corp.2007—

Also cleared against K071857: 4 other devices →

What descends from it? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K080767Conquest Spinal SystemLife Spine200821
K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161

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 23 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
  • 13 of the 139 ancestors have a recall of any class.
  • Of its descendants, K080767 (Life Spine, 2008) has gone furthest, with 21 descendants of its own.
  • 4 other devices also cite its predicate K071857.

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. 2008, 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 and noncervical nonpedicle fixation as an adjunct to fusion for the following acute and chronic instabilities or deformities for the Ti-Si vertebrae in skeletally mature patients: 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 K071857

4 other devices cite the same predicate.

  • K123476Mega 5.5 Spine SystemLsk Biopartners, Inc. · 2013
  • K111995Xingtm Spine SystemImplanova Co., Ltd. · 2011
  • K083077Ulc Spinal Pedicle Screw SystemOtis Biotech Co., Ltd. · 2009
  • K072022Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2007

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/K073430 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073430: 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/K073430

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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