510(k) Report

FDA applicant

Integrated Surgical Systems, Inc.

Sacramento, CA4 decisions1997–20080 recalls

FDA records 4 decisions for Integrated Surgical Systems, Inc. (Sacramento, CA) from 1997 to 2008: 4 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and HWT (Template). Its devices cite 6 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Integrated Surgical Systems, S.A.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Integrated Surgical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • HAWNeurological Stereotaxic Instrument2decisions
  • HWTTemplate1decision
  • OJPOrthopedic Computer Controlled Surgical System1decision

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 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.

  • K991081Frameless NeuromateIntegrated Surgical Systems, Inc. · 19996cite it
  • K963256Neuromate Stereotactic SystemIntegrated Surgical Systems, S.A. · 19973cite it
  • K072629Digimatch Robodoc Surgical SystemIntegrated Surgical Systems, Inc. · 20083cite it

What has FDA decided for it lately?

  • K072629Digimatch Robodoc Surgical SystemIntegrated Surgical Systems, Inc. · 2008
  • K991081Frameless NeuromateIntegrated Surgical Systems, Inc. · 1999
  • K963256Neuromate Stereotactic SystemIntegrated Surgical Systems, S.A. · 1997
  • K960685Orthodoc Preoperative Planner Model 500Integrated Surgical Systems, Inc. · 1997

All 3 as Integrated Surgical Systems, Inc. →The one decision as Integrated Surgical Systems, S.A. →