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FDA 510(k)

Prophecy Surgical Planning System

K-Number: K241999 · 2024-11-01

ApplicantWright Medical Technology, Inc. (Stryker)
Decision Date2024-11-01
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Prophecy Surgical Planning System is a medical device manufactured by Wright Medical Technology, Inc. (Stryker). It received FDA 510(k) clearance on 2024-11-01 under approval number K241999. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prophecy Surgical Planning System?

Prophecy Surgical Planning System is a medical device that received FDA 510(k) clearance on 2024-11-01. It is manufactured by Wright Medical Technology, Inc. (Stryker). The 510(k) number is K241999.

When was Prophecy Surgical Planning System approved by the FDA?

Prophecy Surgical Planning System received FDA 510(k) clearance on 2024-11-01, under approval number K241999.

What company makes Prophecy Surgical Planning System?

Prophecy Surgical Planning System is manufactured by Wright Medical Technology, Inc. (Stryker).

What is the FDA product code for Prophecy Surgical Planning System?

The FDA product code for Prophecy Surgical Planning System is HSN.

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41915013 Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. Clinical orthopaedics and related research (2026) PMID: 41543479 Ethical and Regulatory Considerations for Artificial Intelligence Adoption in Craniofacial Surgery. The Journal of craniofacial surgery () PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Wright Medical Technology, Inc. (Stryker)

K250037Incompass Total Ankle System

Related Devices (Code: HSN)

K153452Salto XT, Salto TalarisTornier S.A.S. K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K152217Exactech Vantage Total Ankle SystemExactech, Inc. K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC K171067INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K170968PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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