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FDA 510(k)

Additive Orthopaedics Patient Specific 3D Printed Bone Segments

K-Number: K180239 · 2018-05-16

ApplicantAdditive Orthopaedics, LLC
Decision Date2018-05-16
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Additive Orthopaedics Patient Specific 3D Printed Bone Segments is a medical device manufactured by Additive Orthopaedics, LLC. It received FDA 510(k) clearance on 2018-05-16 under approval number K180239. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Additive Orthopaedics Patient Specific 3D Printed Bone Segments?

Additive Orthopaedics Patient Specific 3D Printed Bone Segments is a medical device that received FDA 510(k) clearance on 2018-05-16. It is manufactured by Additive Orthopaedics, LLC. The 510(k) number is K180239.

When was Additive Orthopaedics Patient Specific 3D Printed Bone Segments approved by the FDA?

Additive Orthopaedics Patient Specific 3D Printed Bone Segments received FDA 510(k) clearance on 2018-05-16, under approval number K180239.

What company makes Additive Orthopaedics Patient Specific 3D Printed Bone Segments?

Additive Orthopaedics Patient Specific 3D Printed Bone Segments is manufactured by Additive Orthopaedics, LLC.

What is the FDA product code for Additive Orthopaedics Patient Specific 3D Printed Bone Segments?

The FDA product code for Additive Orthopaedics Patient Specific 3D Printed Bone Segments is HRS.

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Related PubMed Literature

PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026) PMID: 41967338 Patient-tailored brachytherapy applicator development in compliance with the EU medical device regulation. Physica medica : PM : an international journal devoted to the applications of physics to medicine and biology : official journal of the Italian Association of Biomedical Physics (AIFB) (2026) PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41770469 Use and regulation of patient-specific three-dimensional printing in medicine: a survey of physician end-users. 3D printing in medicine (2026)

Other Devices by Additive Orthopaedics, LLC

K153207Additive Orthopaedics Bone Wedge System K160264Additive Orthopaedics Hammertoe Correction System K163593Additive Orthopaedics Bunion System K170214Additive Orthopaedics Locking Lattice Plate K211076Patient Specific Marking Guides

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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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