Cleared Traditional

EmbedMed (K221943) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221943 · 3D Lifeprints UK , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
211d
Days
Class 2
Risk

K221943 is an FDA 510(k) clearance for the EmbedMed. Classified as Orthopaedic Surgical Planning And Instrument Guides (product code PBF), Class II - Special Controls.

Submitted by 3D Lifeprints UK , Ltd. (West Derby, Liverpool, Merseyside, GB). The FDA issued a Cleared decision on February 1, 2023 after a review of 211 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all 3D Lifeprints UK , Ltd. devices

Submission Details

510(k) Number K221943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2022
Decision Date February 01, 2023
Days to Decision 211 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 122d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PBF Orthopaedic Surgical Planning And Instrument Guides
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
Definition As A Surgical Instrument To Assist In Pre-operative Planning And/or Guiding The Marking Of Bone And/or Guide Surgical Instruments For Orthopedic Surgical Procedures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Olympus Regulatory Solutions
Sam Murray

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PBF Orthopaedic Surgical Planning And Instrument Guides

All 23
Devices cleared under the same product code (PBF) and FDA review panel - the closest regulatory comparables to K221943.
MedCAD AccuPlan Orthopedics System
K223421 · Medcad · Sep 2023
Fine Osteotomy™
K231314 · Bodycad Laboratories, Inc. · Jun 2023
MyPAO Guides
K220706 · Medacta International S.A. · May 2023
CenterMed Patient Matched Assisted Surgical Planning (ASP) System
K211614 · Centermed, Inc. · Aug 2022
Patient Specific Marking Guides
K211076 · Additive Orthopaedics, LLC · Jun 2022
RedPoint Medical's Better Bunion System
K220717 · Redpoint Medical, LLC · Jun 2022