510(k) Report

510(k) · Cleared

Cleared

Vertebron PSS Pedicle Screw System

K051716510(k) SpecialCleared Sep 7, 200572-day reviewClass II21 CFR 888.3050

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

Vertebron, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Sep 7, 2005 as substantially equivalent to K033352 (Vertebron, Inc., 2004) and 2 other predicates after a 72-day review. Its family tree reaches back 6 generations to 1995. 56 later devices descend from it.

Decided
Sep 7, 2005
Review
72 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K951116 (1995). 25 ancestors in all, the oldest K933881 (1994). 56 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2002: 2 other ancestors2000: 3 other ancestors1997: 2 other ancestors2001: 1 other ancestor1999: 1 other ancestor1998: 3 other ancestors1996: 3 other ancestors1995: 2 other ancestors1994: 1 other ancestor2013: 4 descendants cleared2008: 4 descendants cleared2007: 1 descendant cleared2023: 4 descendants cleared2018: 2 descendants cleared2015: 3 descendants cleared2019: 3 descendants cleared2022: 5 descendants cleared2020: 5 descendants cleared2025: 7 descendants cleared2016: 1 descendant cleared2021: 4 descendants cleared2009: 1 descendant cleared2012: 1 descendant cleared2024: 5 descendants cleared2014: 3 descendants cleared2026: 3 descendants clearedK951116 · Acromed Pedicle Screw · Acromed Corp. · 1995K963639 · Acromed Pedicle Screw · Acromed Corp. · 1996K982511 · Depuy Motech Moss Miami Spinal Systems · Depuy, Inc. · 1998K030383 · Modification to Moss Miami Spinal System Polyaxial Screws · Depuyacromed · 2003K033352 · Vertebron PSS Pedicle Screw System · Vertebron, Inc. · 2004K043152 · Vertebron PSS Pedicle Screw System · Vertebron, Inc. · 20051990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 5 other ancestors3 generations back: 7 other ancestors4 generations back: 6 other ancestors 1 generation forward: 7 descendants2 generations forward: 8 descendants3 generations forward: 7 descendants4 generations forward: 10 descendants5 generations forward: 11 descendants6 generations forward: 8 descendants7 generations forward: 3 descendants8 generations forward: 1 descendant9 generations forward: 1 descendant K043152 · Vertebron PSS Pedicle Screw System · Vertebron, Inc. · 2005K033352 · Vertebron PSS Pedicle Screw System · Vertebron, Inc. · 2004K030383 · Modification to Moss Miami Spinal System Polyaxial Screws · Depuyacromed · 2003K982511 · Depuy Motech Moss Miami Spinal Systems · Depuy, Inc. · 1998K963639 · Acromed Pedicle Screw · Acromed Corp. · 1996K951116 · Acromed Pedicle Screw · Acromed Corp. · 1995−50+5
  1. Root · 6 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
  2. 5 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
  3. 4 generations backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
  4. 3 generations backK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
  5. 2 generations backK033352 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2004
  6. 1 generation backK043152 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2005
  7. This deviceK051716 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2005
  8. Descendant · cites it directly · 49 of its ownK071376 Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2007
  9. Descendant · 2 generations on · 24 of its ownK073430 Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2008
  10. Descendant · cites it directly · 22 of its ownK081597 Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2008
  11. Descendant · 3 generations on · 21 of its ownK080767 Conquest Spinal SystemLife Spine · 2008
  12. Descendant · 4 generations on · 17 of its ownK123373 Nautilus Spinal SystemLife Spine · 2013

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

2007: 12008: 42009: 12012: 12013: 42014: 32015: 32016: 12018: 22019: 32020: 52021: 42022: 52023: 42024: 52025: 72026: 3
2007high 7 (2025) · low 0 (2010)2026

Most influential descendants

Showing 5 of 56 · See all
  • K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2007 · cites it directly49descendants
  • K073430Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2008 · 2 generations on24descendants
  • K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2008 · cites it directly22descendants
  • K080767Conquest Spinal SystemLife Spine · 2008 · 3 generations on21descendants
  • K123373Nautilus Spinal SystemLife Spine · 2013 · 4 generations on17descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K951116Acromed Pedicle ScrewAcromed Corp.1995—
−5K963639Acromed Pedicle ScrewAcromed Corp.1996—
−4K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc.1998—
−3K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed2003—
−2K033352Vertebron PSS Pedicle Screw SystemVertebron, Inc.2004—
−1K043152Vertebron PSS Pedicle Screw SystemVertebron, Inc.2005—
0 (this device)K051716Vertebron PSS Pedicle Screw SystemVertebron, Inc.2005—
+1K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.2007—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.2008—
+1K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.2008—
+3K080767Conquest Spinal SystemLife Spine2008—
+4K123373Nautilus Spinal SystemLife Spine2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199520
199630
199720
199830
199910
200030
200110
200220
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200840
200910
201210
201340
201430
201530
201610
201820
201930
202050
202140
202250
202340
202450
202570
202630
FIG. 1 — Lineage of K051716, 1995–2026Source: 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K033352Vertebron PSS Pedicle Screw System
Summary page 1
…ew Spinal System PROPRIETARY NAME: VERTEBRON PSSTM Pedicle Screw System PREDICATE DEVICES: VERTEBRON PSS TM Pedicle Screw System - K033352 & K043152 DEVICE DESCRIPTION: The VERTEBRON PSS TM Pedicle Screw System is…
Vertebron, Inc.2004—
*K043152Vertebron PSS Pedicle Screw System
Summary page 1
…VERTEBRON PSSTM Pedicle Screw System PREDICATE DEVICES: VERTEBRON PSS TM Pedicle Screw System - K033352 & K043152 DEVICE DESCRIPTION: The VERTEBRON PSS TM Pedicle Screw System is comprised…
Vertebron, Inc.2005—
*K024096Optima, Spinal System
Summary page 2
…e VERTEBRON PSSTM Pedicle Screw System (K033352 & K043152), and Optima Spinal Fixation System; U&I America (K024096), which have received market clearance by the FDA. DEPARTMENT OF HEALTH & HUM…
U&I Corp., America20033

Also cleared against K033352: 8 other devices →

What descends from it? (56)

See all 56

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

NumberDeviceApplicantDecidedDescendants
K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200749
K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200822
K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314
K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186
K132280Altus Spine Pedicle Screw SystemAltus Partners20136
K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231
K073531Accin Pedicle Screw SystemAccelerated Innovation, LLC20080

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 10 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
  • 2 of the 25 ancestors have a recall of any class.
  • Of its descendants, K071376 (Vertebron, Inc., 2007) has gone furthest, with 49 descendants of its own.
  • 8 other devices also cite its predicate K033352.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

What is it indicated for?

The VERTEBRON PSS TM Pedicle Screw System is intended for noncervical, nonpedicle fixation 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; pseudoarthrosis; and failed previous fusion in…

Read the full statement (119 words)

The VERTEBRON PSS TM Pedicle Screw System is intended for noncervical, nonpedicle fixation 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON PSS' TM Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Indications for use as stated in the FDA summary.

Also cleared against K033352

8 other devices cite the same predicate.

  • K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC · 2022
  • K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System…Altus Partners, LLC · 2015
  • K132280Altus Spine Pedicle Screw SystemAltus Partners · 2013
  • K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC · 2013
  • K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2008
  • K073531Accin Pedicle Screw SystemAccelerated Innovation, LLC · 2008

More from Vertebron, Inc.

11 FDA decisions under this applicant name. See the company

  • K081567Vertebron SSP Cervical Plating SystemVertebron, Inc. · 2008
  • K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2008
  • K073502Vertebron VBR SystemVertebron, Inc. · 2008
  • K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2007
  • K062110Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2006

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K051716 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051716: Vertebron PSS Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051716

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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