510(k) Report

FDA applicant

Choicespine, LP

Knoxville, TN26 decisions2008–20190 recalls

FDA records 26 decisions for Choicespine, LP (Knoxville, TN) from 2008 to 2019: 26 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 83 days from receipt to decision, against 94 for FDA’s reviews in the same codes and years. Its devices cite 82 predicates, 22 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Choicespine”.

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 Choicespine, LP’s devices, and how often a recall has named them.

FDA decisions per year

5in 2019

2008: 12009: 12010: 12012: 22014: 32015: 12016: 32017: 62018: 32019: 5
2008high 6 (2017) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Choicespine, LP by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Choicespine, LP’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • NKBThoracolumbosacral Pedicle Screw System6decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar5decisions
  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical3decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body3decisions
  • MQPSpinal Vertebral Body Replacement Device3decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision

Also: MRW (1), NQW (1), OVD (1), KWP (1), OLO (1).

How long do its 510(k) reviews take?

Since 2016, its 16 510(k)s took a median of 83 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 94 days; 8 of its 16 were faster than that.

Whose devices does it build on?

Its devices cite 82 predicates; 22 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 67 times; 22 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.

  • K172816TiGer Shark™ SystemChoicespine, LP · 20189cite it
  • K170953Tomcat Cervical Spinal SystemChoicespine, LP · 20176cite it
  • K073669Oria Natura SpacerChoicespine, LP · 20085cite it
  • K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 20145cite it
  • K171489Acapella Cervical Spacer SystemChoicespine, LP · 20174cite it
  • K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 20174cite it

What has FDA decided for it lately?

  • K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP · 2019
  • K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP · 2019
  • K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine · 2019
  • K182721Choice Spine Navigation SystemChoicespine, LP · 2019
  • K183214Raven Lumbar Plate SystemChoicespine, LP · 2019
  • K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP · 2018
  • K172816TiGer Shark™ SystemChoicespine, LP · 2018
  • K173215Choice Spine Laminoplasty™ Fixation SystemChoicespine, LP · 2018

All 22 as Choicespine, LP →All 4 as Choicespine →