510(k) Report

FDA applicant

Theken Spine, LLC

Akron, OH23 decisions2007–20123 recalls

FDA records 23 decisions for Theken Spine, LLC (Akron, OH) from 2007 to 2012: 23 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and OVD (Intervertebral Fusion Device With Integrated…). Its devices cite 61 predicates, 17 of them its own earlier devices. 3 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 Theken Spine, LLC’s devices, and how often a recall has named them.

FDA decisions per year

4in 2012

2007: 62008: 42009: 42010: 32011: 22012: 4
2007high 6 (2007) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2011

2010: 22011: 1
2007high 2 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Theken Spine, LLC by year, 2007–2026Sources: 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 System6decisions
  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar3decisions
  • MQPSpinal Vertebral Body Replacement Device3decisions
  • KWPAppliance, Fixation, Spinal Interlaminal2decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar2decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body2decisions

Also: MNI (2), ODP (1), HRX (1), OVE (1).

Whose devices does it build on?

Its devices cite 61 predicates; 17 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 68 times; 17 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.

  • K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 201011cite it
  • K080822VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC · 20089cite it
  • K070638Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC · 20076cite it
  • K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 20126cite it
  • K070962Coral Pedicle Screw SystemTheken Spine, LLC · 20076cite it
  • K083863Theken Atoll Oct Spinal SystemTheken Spine, LLC · 20095cite it

What has FDA decided for it lately?

  • K121482Instrument System for Endoscopic Spinal SurgeryTheken Spine, LLC · 2012
  • K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2012
  • K120829Stainless Steel Spinal SystemTheken Spine, LLC · 2012
  • K120047Coral Spinal SystemTheken Spine, LLC · 2012
  • K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2011
  • K103228Paramount R Ibf DeviceTheken Spine, LLC · 2011
  • K102323Cervical Standalone Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010
  • K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010

All 23 as Theken Spine, LLC →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K080690Manta Ray" Anterior Cervical Plate (ACP) System, Intended use: The Manta Ray ACP System…Jan 10, 2011
  • K080822Vu a-POD Intervertebral Body Fusion Device. Packaged as surgical kits containing all…Oct 19, 2010
  • K080690Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the…Jul 29, 2010

Other applicant names beginning “Theken”

FDA records each applicant name separately; these may or may not be the same firm.

Theken Surgical,Llc 9Theken Companies, LLC 5