Orthopedics AI medical devices

A neutral, evidence-based catalogue of orthopedics AI medical devices. No manufacturer pricing, no buy links — just regulatory facts and clinical capability summaries.

Orthopedics

Precision AI Surgical Planning System (PAI-SPS)

Precision AI Pty Ltd

FDA

Pre-surgical planning software for total and reverse shoulder arthroplasty, paired with 3D-printed patient-specific guides. A locked machine-learning algorithm segments the patient's CT scan into a three-dimensional model of the scapula and humerus and places the anatomical landmarks. The surgeon then positions the chosen glenoid and humeral components on that model, measures and edits the plan and approves it. If requested, the approved plan drives the design of a single-use glenoid guide (for the k-wire) and humeral guide (for the head-resection pins), printed in polyamide by selective laser sintering. Three FDA clearances between August 2024 and January 2026 extended the compatible implant list from four Enovis systems to the Enovis and Lima shoulder ranges and added an optional anatomical shape-reconstruction feature. The 2025 clinical paper names the software ASTRA, previously Precision AI, and lists Enovis as its manufacturer.

Orthopedics

BoneView

Gleamer

CEFDAHC

Deep-learning decision support that flags acute fractures on musculoskeletal trauma radiographs, marking suspicious regions for the reading clinician. In the United States the cleared use is fracture detection: in adults across the limbs, pelvis, rib cage and dorsolumbar spine, and — since a 2023 clearance — in children aged two and older on limb radiographs. The wider CE-marked product additionally reports dislocations, elbow joint effusions and focal bone lesions, a broader scope than the US label carries.

Orthopedics

UNiD Spine Analyzer

Medicrea International S.A.S. (Medtronic)

Editorial summaryOrthopedics

OrthoGrid Hip AI 4.0

OrthoGrid Systems, Inc.

Editorial summaryOrthopedics

United Orthopedic Knee Patient Specific Instrumentation

Enhatch, Inc.

Sourced from FDA AI listOrthopedics

Precision AI Surgical Planning System (PAI-SPS)

Precision AI Pty, Ltd.

Sourced from FDA AI listOrthopedics

MyShoulder Planner (5.3SSWPL)

Medacta International S.A.

Sourced from FDA AI listOrthopedics

Veritas Reverse Total Shoulder System

Restor3D

Sourced from FDA AI listOrthopedics

Signature™ ONE System

Orthosoft Inc. (d/b/a) Zimmer CAS

Sourced from FDA AI listOrthopedics

GoLIF! Lumbar Interbody Fusion System

GetSet Surgical, SA

Sourced from FDA AI list

Other specialties