Atlas FDA

Precision AI Surgical Planning System (PAI-SPS)

FDA 510(k) clearance K243955 · decided 2025-01-21

Clearance details

K-number
K243955
Device name
Precision AI Surgical Planning System (PAI-SPS)
Applicant
Precision AI Pty, Ltd.
Decision
Substantially Equivalent
Date received
2024-12-23
Decision date
2025-01-21
Days to decision
29 days
Clearance type
Special
Product code
QHE
Device class
2
Regulation number
888.3660
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Fortitude Valley, AU
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K260802)Materialise NV2026-06-09
Signature™ ONE System (K261510)Orthosoft Inc. (d/b/a) Zimmer CAS2026-06-04
Signature™ ONE System (K260104)Orthosoft Inc. (d/b/a) Zimmer CAS2026-02-04
Precision AI Surgical Planning System (PAI-SPS) (K251558)Precision AI Pty, Ltd.2026-01-12
Archer PSI System (K243509)3D-Side2025-05-12
CORE Shoulder System (K241470)LinkBio Corp.2025-02-20
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K242813)Materialise NV2024-10-18
Arthrex Virtual Implant Positioning (VIP) System Software (K241097)Arthrex, Inc.2024-10-02
Precision AI Surgical Planning System (PAI-SPS) (K233992)Precision AI Pty, Ltd.2024-08-05
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K241143)Materialise NV2024-05-22
Signature™ ONE System (K232425)Orthosoft Inc. (D/B/A) Zimmer Cas)2023-12-12
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K233408)Materialise NV2023-11-09

Recalls involving this device

No recalls on record reference this clearance.