510(k) Report

FDA applicant

Adaptive Specialty, LLC

Round Rock, TX2 decisions2009–20120 recalls

FDA records 2 decisions for Adaptive Specialty, LLC (Round Rock, TX) from 2009 to 2012: 2 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and ODP (Intervertebral Fusion Device With Bone Graft…). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is 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 Adaptive Specialty, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2009: 12012: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Adaptive Specialty, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HRSPlate, Fixation, Bone1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K083425Fusion Advantage Cervical Cage, Fusion Advantage Lumbar CageAdaptive Specialty, LLC · 20092cite it

What has FDA decided for it lately?

  • K110662Adaptive WedgeAdaptive Specialty, LLC · 2012
  • K083425Fusion Advantage Cervical Cage, Fusion Advantage Lumbar CageAdaptive Specialty, LLC · 2009

All 2 as Adaptive Specialty, LLC →

Other applicant names beginning “Adaptive”

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

Adaptive Switch Laboratories, Inc. 4Adaptive Video, Inc. 3Adaptive Biotechnologies Corporation 2Adaptive Healthcare Technologies, Inc. 1