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FDA 510(k)

Patient Specific Marking Guides

K-Number: K211076 · 2022-06-28

ApplicantAdditive Orthopaedics, LLC
Decision Date2022-06-28
Product CodePBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Patient Specific Marking Guides is a medical device manufactured by Additive Orthopaedics, LLC. It received FDA 510(k) clearance on 2022-06-28 under approval number K211076. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Patient Specific Marking Guides?

Patient Specific Marking Guides is a medical device that received FDA 510(k) clearance on 2022-06-28. It is manufactured by Additive Orthopaedics, LLC. The 510(k) number is K211076.

When was Patient Specific Marking Guides approved by the FDA?

Patient Specific Marking Guides received FDA 510(k) clearance on 2022-06-28, under approval number K211076.

What company makes Patient Specific Marking Guides?

Patient Specific Marking Guides is manufactured by Additive Orthopaedics, LLC.

What is the FDA product code for Patient Specific Marking Guides?

The FDA product code for Patient Specific Marking Guides is PBF.

Related Clinical Trials

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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: 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) PMID: 41596046 A Review of 3D-Printed Medical Devices for Cancer Radiation Therapy. Bioengineering (Basel, Switzerland) (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 K180239Additive Orthopaedics Patient Specific 3D Printed Bone Segments

Related Devices (Code: PBF)

K163156SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesMaterialise NV K190044VSP Orthopedics System3D Systems, Inc. K192979KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. K2122373D-Cut3D-Side S.A. K211244VSP® Orthopedics System3D Systems K211614CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc.

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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