510(k) Report

FDA applicant

Lanx, Inc.

Broomfield, CO36 decisions2004–20136 recalls

FDA records 36 decisions for Lanx, Inc. (Broomfield, CO) from 2004 to 2013: 36 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and KWP (Appliance, Fixation, Spinal Interlaminal). Its devices cite 89 predicates, 48 of them its own earlier devices. 6 recalls are linked to its devices.

FDA’s records also spell it “Lanx, LLC”.

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 Lanx, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2013

2007: 32008: 22009: 72010: 52011: 82012: 42013: 3
2007high 8 (2011) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

4in 2013

2011: 12012: 12013: 4
2007high 4 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Lanx, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • NKBThoracolumbosacral Pedicle Screw System9decisions
  • KWPAppliance, Fixation, Spinal Interlaminal7decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body5decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar4decisions
  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar3decisions
  • MNIOrthosis, Spinal Pedicle Fixation3decisions

Also: OVE (1), MNH (1), MQP (1), ODP (1), MRW (1).

Whose devices does it build on?

Its devices cite 89 predicates; 48 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 121 times; 48 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.

  • K071877Lanx Spinal Fixation SystemLanx, LLC · 200718cite it
  • K090252Modification to: Lanx Spinal Fixation SystemLanx, Inc. · 20098cite it
  • K123767Lanx Fusion System- SALanx, Inc. · 20137cite it
  • K083815Lanx Fusion SystemLanx, Inc. · 20096cite it
  • K043484Lanx Spinal Fixation SystemLanx, LLC · 20056cite it
  • K073144Lanx Intervertebral Body Fusion DeviceLanx, LLC · 20085cite it

What has FDA decided for it lately?

  • K131547Lanx Fusion SystemLanx, Inc. · 20131 recall
  • K131156Lanx Spinal Fixation SystemLanx, Inc. · 2013
  • K123767Lanx Fusion System- SALanx, Inc. · 20134 recalls
  • K121316Lanx Spinal Fization SystemLanx, Inc. · 2012
  • K122145Lanx Spinal Fixation SystemLanx, Inc. · 20121 recall
  • K121940Lanx Spinal Fixation SystemLanx, Inc. · 2012
  • K120399Lanx Spinal Fixation SystemLanx, LLC · 2012
  • K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc. · 2011

All 23 as Lanx, Inc. →All 13 as Lanx, LLC →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K123767LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver -…Nov 4, 2013Class II
  • K123767Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No.…Aug 22, 2013Class II
  • K123767Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102.…Aug 22, 2013Class II
  • K123767Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline…Aug 22, 2013Class II
  • K122145Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is…Nov 30, 2012Class II
  • K102738LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case.…Mar 9, 2011Class II