510(k) Report

FDA applicant

Biomedical Enterprises, Inc.

San Antonio, TX10 decisions2002–20163 recalls

FDA records 10 decisions for Biomedical Enterprises, Inc. (San Antonio, TX) from 2002 to 2016: 10 510(k) clearances. Most are in product codes JDR (Staple, Fixation, Bone) and HRS (Plate, Fixation, Bone). Its devices cite 21 predicates, 2 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 Biomedical Enterprises, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007: 12013: 12014: 32015: 22016: 1
2007high 3 (2014) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

3in 2022

2022: 3
2007high 3 (2022) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Biomedical Enterprises, 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?

  • JDRStaple, Fixation, Bone4decisions
  • HRSPlate, Fixation, Bone2decisions
  • JEYPlate, Bone2decisions
  • HTYPin, Fixation, Smooth1decision
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision

Whose devices does it build on?

Its devices cite 21 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 22 times; 2 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.

  • K142292Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc. · 20149cite it
  • K124022Speed ShiftBiomedical Enterprises, Inc. · 20135cite it
  • K133520Hammerlock 2Biomedical Enterprises, Inc. · 20143cite it
  • K150125Elite Nitinol Fixation SystemBiomedical Enterprises, Inc. · 20152cite it
  • K143023Nitinol Compression Plating SystemBiomedical Enterprises, Inc. · 20151cites it
  • K133270Speed ArcBiomedical Enterprises, Inc. · 20141cites it

What has FDA decided for it lately?

  • K153573ConvergeBiomedical Enterprises, Inc. · 2016
  • K150125Elite Nitinol Fixation SystemBiomedical Enterprises, Inc. · 2015
  • K143023Nitinol Compression Plating SystemBiomedical Enterprises, Inc. · 2015
  • K142292Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc. · 20143 recalls
  • K133270Speed ArcBiomedical Enterprises, Inc. · 2014
  • K133520Hammerlock 2Biomedical Enterprises, Inc. · 2014
  • K124022Speed ShiftBiomedical Enterprises, Inc. · 2013
  • K061385Osstaple, Ossplate, OssforceBiomedical Enterprises, Inc. · 2007

All 10 as Biomedical Enterprises, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K142292SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with…Sep 27, 2022Class II
  • K142292SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910Sep 27, 2022Class II
  • K142292SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512Sep 27, 2022Class II