ARVIS® Shoulder

K243950

Kico Knee Innovation Company Pty Ltd · cleared 2025-01-13 · product code SBF · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“ARVIS® Shoulder is a computer-controlled navigation system for shoulder arthroplasty. It aids the surgeon in making intra-operative measurements and locating anatomical structures of the shoulder joint based on the patient's preoperative imaging to assist with selection and positioning of orthopedic implant components. The system consists of software, electronic hardware and surgical instruments. The preoperative planning platform uses Al-based automatic image segmentation and landmarking algorithms.”
AlgorithmAI-based automatic image segmentation and landmarking algorithms
source quote (p.6)
“The preoperative planning platform uses Al-based automatic image segmentation and landmarking algorithms.”
Adaptive (vs locked)No
source quote (p.6)
“The algorithms and the data used to train and test these remain unchanged from the original submission.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=300 patients

Bench

sample size not stated

endpoints: Software Verification and Validation

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

1
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code SBF (Kico Knee Innovation Company, initiated 2025-09-19): "Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion." Recalling firm matches this device's applicant.

    first seen 2026-07-08 · recall res_event_number:97618

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Kico Knee Innovation Company) — same firm and product code, not necessarily this device · initiated 2025-09-19

    Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.

    recall event 97618 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Neurology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K243950