510(k) Report

FDA applicant

Buckman Co., Inc.

Martinez, CA111 decisions1983–19983 recalls

FDA records 111 decisions for Buckman Co., Inc. (Martinez, CA) from 1983 to 1998: 111 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and BXB (Exerciser, Powered). Its devices cite 15 predicates, 1 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 Buckman Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Buckman Co., Inc. since 2007.

Recalls per year

1in 2016

2007: 12011: 12016: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Buckman Co., Inc. 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?

  • HWCScrew, Fixation, Bone8decisions
  • BXBExerciser, Powered8decisions
  • GEXPowered Laser Surgical Instrument5decisions
  • KWPAppliance, Fixation, Spinal Interlaminal5decisions
  • HSBRod, Fixation, Intramedullary And Accessories4decisions
  • JDWPin, Fixation, Threaded4decisions

Also: MNH (3), HTN (3), HTY (2), HRS (2), JEC (2), JWH (2).

Whose devices does it build on?

Its devices cite 15 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 67 times; 1 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.

  • K950099Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 199735cite it
  • K934429Anterior Spine SystemBuckman Co., Inc. · 19944cite it
  • K882322Continuum Knee System (CKS)Buckman Co., Inc. · 19893cite it
  • K871539Zindrick IM RodBuckman Co., Inc. · 19873cite it
  • K875012Ace/Fischer Percutaneous Half PinsBuckman Co., Inc. · 19883cite it
  • K895107Ace Orthopaedic WashersBuckman Co., Inc. · 19893cite it

What has FDA decided for it lately?

  • K961320Cross Medical Bone Plate System/ CM Bone Plate System/Cross TI Bone Plate SystemBuckman Co., Inc. · 1998
  • K974641Futurelase 3000/3002 Erbium Laser SystemBuckman Co., Inc. · 1998
  • K964252OrthochuckBuckman Co., Inc. · 1997
  • K950099Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
  • K960451Webb-Morley Spine SystemBuckman Co., Inc. · 1996
  • K950999KSF Posterior Spingal Fixator for Severe SpondylolisthesisBuckman Co., Inc. · 1996
  • K945756Imagn (TM) 2000 SystemBuckman Co., Inc. · 1995
  • K940003Volumet CD4 + and CD8 + T Lymphocyte Count Test KitBuckman Co., Inc. · 1995

All 111 as Buckman Co., Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K063570Various trauma and sports medicine instruments and implants. Rod, fixation…Apr 1, 2016Class II
  • K860018Offset Wire Fixation Bolt, catalog number 8180-50-006. The bolts are used with the DePuy…Nov 8, 2011
  • K891405BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used during…Jul 17, 2007

Other applicant names beginning “Buckman”

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

Buckman Consultants 3