Cleared Traditional

K200384 - HipXpert 3D Display and Anchoring Application (FDA 510(k) Clearance)

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

K200384 · Surgical Planning Associates, Inc. · Orthopedic device
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Jan 2021
Decision
345d
Days
Class 2
Risk

K200384 is an FDA 510(k) clearance for the HipXpert 3D Display and Anchoring Application. Classified as Patient Specific Manual Orthopedic Stereotaxic System (product code OSF), Class II - Special Controls.

Submitted by Surgical Planning Associates, Inc. (Boston, US). The FDA issued a Cleared decision on January 28, 2021 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - 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. Elevated predicate reliance profile. 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 Surgical Planning Associates, Inc. devices

Submission Details

510(k) Number K200384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2020
Decision Date January 28, 2021
Days to Decision 345 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
223d slower than avg
Panel avg: 122d · This submission: 345d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OSF Patient Specific Manual Orthopedic Stereotaxic System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Intended For Defining Orthopedic Acetabular Implant Alignment Relative To A Patient's Anatomy.
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

Orchid Design
Kellen Hills

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.