510(k) Report

510(k) · Cleared

Cleared

Accin Pedicle Screw System

K073531510(k) TraditionalCleared Feb 4, 200849-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

Accelerated Innovation, LLC · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Feb 4, 2008 as substantially equivalent to K033352 (Vertebron, Inc., 2004) and 3 other predicates after a 49-day review. Its family tree reaches back 8 generations to 1995.

Decided
Feb 4, 2008
Review
49 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
4

Its longest line of descent runs back 8 generations to K951116 (1995). 27 ancestors in all, the oldest K933881 (1994). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor2002: 2 other ancestors1997: 2 other ancestors2001: 1 other ancestor2000: 3 other ancestors1999: 1 other ancestor1998: 3 other ancestors1996: 3 other ancestors1995: 2 other ancestors1994: 1 other ancestorK951116 · 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. · 2005K051716 · Vertebron PSS Pedicle Screw System · Vertebron, Inc. · 2005K071376 · Modification to Vertebron PSS Pedicle Screw System · Vertebron, Inc. · 200719901995200020052010
Other ancestors, by generation 2 generations back: 3 other ancestors3 generations back: 9 other ancestors4 generations back: 7 other ancestors K071376 · Modification to Vertebron PSS Pedicle Screw System · Vertebron, Inc. · 2007K051716 · Vertebron PSS Pedicle Screw System · Vertebron, Inc. · 2005K043152 · 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
  1. Root · 8 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
  2. 7 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
  3. 6 generations backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
  4. 5 generations backK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
  5. 4 generations backK033352 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2004
  6. 3 generations backK043152 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2005
  7. 2 generations backK051716 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2005
  8. 1 generation backK071376 Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2007
  9. This deviceK073531 Accin Pedicle Screw SystemAccelerated Innovation, LLC · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K951116Acromed Pedicle ScrewAcromed Corp.1995—
−7K963639Acromed Pedicle ScrewAcromed Corp.1996—
−6K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc.1998—
−5K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed2003—
−4K033352Vertebron PSS Pedicle Screw SystemVertebron, Inc.2004—
−3K043152Vertebron PSS Pedicle Screw SystemVertebron, Inc.2005—
−2K051716Vertebron PSS Pedicle Screw SystemVertebron, Inc.2005—
−1K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.2007—
0 (this device)K073531Accin Pedicle Screw SystemAccelerated Innovation, LLC2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199520
199630
199720
199830
199910
200030
200110
200220
200310
FIG. 1 — Lineage of K073531, 1995–2008Source: 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 MNH? 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? (4)

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
…87KWQ- Appliance, Fixation, Spinal Intervertebral Body, 21CFR 880.3060, Class II Predicate Device: Vertebron PSS System - K033352, K043152, K051716 and K071376 Device Description: The AccinTM Pedicle System consists of titanium alloy rods, cannula…
Vertebron, Inc.2004—
*K043152Vertebron PSS Pedicle Screw System
Summary page 1
…Appliance, Fixation, Spinal Intervertebral Body, 21CFR 880.3060, Class II Predicate Device: Vertebron PSS System - K033352, K043152, K051716 and K071376 Device Description: The AccinTM Pedicle System consists of titanium alloy rods, cannulated, mult…
Vertebron, Inc.2005—
*K051716Vertebron PSS Pedicle Screw System
Summary page 1
…e, Fixation, Spinal Intervertebral Body, 21CFR 880.3060, Class II Predicate Device: Vertebron PSS System - K033352, K043152, K051716 and K071376 Device Description: The AccinTM Pedicle System consists of titanium alloy rods, cannulated, multi-…
Vertebron, Inc.2005—
*K071376Modification to Vertebron PSS Pedicle Screw System
Summary page 1
…Spinal Intervertebral Body, 21CFR 880.3060, Class II Predicate Device: Vertebron PSS System - K033352, K043152, K051716 and K071376 Device Description: The AccinTM Pedicle System consists of titanium alloy rods, cannulated, multi-…
Vertebron, Inc.2007—

Also cleared against K033352: 8 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 13 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
  • 2 of the 27 ancestors have a recall of any class.
  • 8 other devices also cite its predicate K033352.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—0—

What is it indicated for?

The AccinTM Pedicle Screw System components are intended for noncervical and nonpedicle anterolateral fixation of: * Degenerative disk disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); * Spondylolisthesis (grade 3 or 4) * Trauma (i.e.: fracture or dislocation) * Spinal stenosis * Curvatures (i.e.: scoliosis, kyphosis, and/or lordosis) * Tumor * Pseudoarthrosis * Failed…

Read the full statement (124 words)

The AccinTM Pedicle Screw System components are intended for noncervical and nonpedicle anterolateral fixation of:

* Degenerative disk disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);

* Spondylolisthesis (grade 3 or 4)

* Trauma (i.e.: fracture or dislocation)

* Spinal stenosis

* Curvatures (i.e.: scoliosis, kyphosis, and/or lordosis)

* Tumor

* Pseudoarthrosis

* Failed previous fusion.

The AccinTM Pedicle Screw System components are intended for non-cervical pedicle fixation of:

* Spondylolisthesis (grade 3 or 4)

* Trauma (i.e.: fracture or dislocation)

* Spinal stenosis

* Curvatures (i.e.: scoliosis, kyphosis, and/or lordosis)

* Tumor

* Pseudoarthrosis

Failed previous fusion.

These components are single use only and are intended for use 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
  • K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2007

More from Accelerated Innovation, LLC

7 FDA decisions under this applicant name. See the company

  • K081127Accin Total Knee SystemAccelerated Innovation, LLC · 20081 recall
  • K080647Accin Bipolar Head SystemAccelerated Innovation, LLC · 2008
  • K080539Accin Unipolar Head SystemAccelerated Innovation, LLC · 2008
  • K073120Accin Patellofemoral SystemAccelerated Innovation, LLC · 2008
  • K073530Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC · 2008

Recent decisions in MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K073531 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073531: Accin 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/K073531

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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