Signature™ ONE System

K260104

Orthosoft Inc. (d/b/a) Zimmer CAS · cleared 2026-02-04 · product code QHE · Orthopedic

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.7)
“The Signature™ ONE System is developed to assist in pre-operative planning (using the Signature™ ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides and bone model)... The Signature ONE Guides and Bone Models are designed and manufactured of polyamide (nylon) using additive manufacturing selective laser sintering (SLS)... The AI/ML model is used in the Segmentation step only within the CT Reconstruction internal software application...”
AlgorithmAI/ML locked model for automatic segmentation
source quote (p.7)
“The purpose of the submission is that the CT Reconstruction internal software application was updated with an improved AI/ML locked model for automatic segmentation and also retraining the model with new production grade scapula and humerus CT segmentations.”
Adaptive (vs locked)No
source quote (p.7)
“The purpose of the submission is that the CT Reconstruction internal software application was updated with an improved AI/ML locked model for automatic segmentation and also retraining the model with new production grade scapula and humerus CT segmentations.”
PCCPNo
Cybersecurity addressedNo

Validation studies (0)

FDA source did not describe a validation study.

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
1
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

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 Orthopedic 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/K260104