510(k) Report

FDA applicant

Ldr Spine USA

Austin, TX35 decisions2005–20171 recall

FDA records 35 decisions for Ldr Spine USA (Austin, TX) from 2005 to 2017: 35 510(k) clearances. Most are in product codes MQP (Spinal Vertebral Body Replacement Device) and MNI (Orthosis, Spinal Pedicle Fixation). Since 2016 its 510(k)s took a median of 155 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 80 predicates, 48 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Ldr Spine USA, Inc.”.

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 Ldr Spine USA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007: 32008: 42009: 42010: 32011: 22012: 32013: 12014: 12015: 32016: 42017: 1
2007high 4 (2008) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Ldr Spine USA’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?

  • MQPSpinal Vertebral Body Replacement Device8decisions
  • MNIOrthosis, Spinal Pedicle Fixation5decisions
  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar4decisions
  • NKBThoracolumbosacral Pedicle Screw System3decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar3decisions
  • MQVFiller, Bone Void, Calcium Compound2decisions

Also: MRW (2), OVE (2), ODP (2), KWP (1), MNH (1), PEK (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 155 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 124 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 80 predicates; 48 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 171 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.

  • K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 200951cite it
  • K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc. · 201121cite it
  • K043479MC+ Partial VBRLdr Spine USA · 200518cite it
  • K082262LDR Spine Roi Interbody Fusion SystemLdr Spine USA · 20098cite it
  • K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA · 20157cite it
  • K043094Easyspine SystemLdr Spine USA · 20056cite it

What has FDA decided for it lately?

  • K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc. · 2017
  • K161173Avenue® T TLIF CageLdr Spine USA, Inc. · 2016
  • K161798FacetBRIDGE® SystemLdr Spine USA, Inc. · 2016
  • K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant SystemLdr Spine USA · 20161 recall
  • K152137FacetBRIDGE SystemLdr Spine USA · 2016
  • K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA · 2015
  • K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA · 2015
  • K142645Avenue T TLIF CageLdr Spine USA, Inc. · 2015

All 25 as Ldr Spine USA →All 10 as Ldr Spine USA, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K153495ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number…Aug 29, 2016Class II