Cleared Traditional

CenterMed Patient Matched Assisted Surgical Planning (ASP) System (K211614) - FDA 510(k) Clearance

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

K211614 · Centermed, Inc. · Orthopedic device
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Aug 2022
Decision
435d
Days
Class 2
Risk

K211614 is an FDA 510(k) clearance for the CenterMed Patient Matched Assisted Surgical Planning (ASP) System. Classified as Orthopaedic Surgical Planning And Instrument Guides (product code PBF), Class II - Special Controls.

Submitted by Centermed, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on August 4, 2022 after a review of 435 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Centermed, Inc. devices

Submission Details

510(k) Number K211614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2021
Decision Date August 04, 2022
Days to Decision 435 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
313d slower than avg
Panel avg: 122d · This submission: 435d
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 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 K211614.
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