510(k) Report

FDA applicant

Accel Spine

Dallas, TX10 decisions2012–20146 recalls

FDA records 10 decisions for Accel Spine (Dallas, TX) from 2012 to 2014: 10 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and MAX (Intervertebral Fusion Device With Bone Graft…). Its devices cite 64 predicates, 2 of them its own earlier devices. 6 recalls are linked to its devices.

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

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Accel Spine’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2012: 62013: 32014: 1
2012high 6 (2012) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

4in 2019

2018: 22019: 4
2012high 4 (2019) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Accel Spine by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NKBThoracolumbosacral Pedicle Screw System3decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar2decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body2decisions
  • KWPAppliance, Fixation, Spinal Interlaminal1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • MNIOrthosis, Spinal Pedicle Fixation1decision

Whose devices does it build on?

Its devices cite 64 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K131981Cezanne II Interbody Fusion SystemAccel Spine · 20133cite it
  • K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine · 20123cite it
  • K120714Picasso Mis Spinal Fixation SystemAccel Spine · 20122cite it
  • K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine · 20122cite it
  • K132365Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine · 20132cite it
  • K140219Picasso II Mis Spinal SystemAccel Spine · 20141cites it

What has FDA decided for it lately?

  • K140219Picasso II Mis Spinal SystemAccel Spine · 2014
  • K131981Cezanne II Interbody Fusion SystemAccel Spine · 20134 recalls
  • K132366Spinal Intervertebral Body Fixation OrthosisAccel Spine · 2013
  • K132365Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine · 20132 recalls
  • K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine · 2012
  • K121568Dali Spinal Fixation SystemAccel Spine · 2012
  • K121078Van Gogh Anterior Cervical Plate SystemAccel Spine · 2012
  • K121136Renoir Posterior Cervial Fixation SystemAccel Spine · 2012

All 10 as Accel Spine →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K131981CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.Aug 21, 2019Class II
  • K131981CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.Aug 21, 2019Class II
  • K131981CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.Aug 21, 2019Class II
  • K131981CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.Aug 21, 2019Class II
  • K132365CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050Jul 5, 2018Class II
  • K132365CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050Jul 5, 2018Class II