Cleared Traditional

K202883 - Sterile bone screw (PEEK ACL screw)

K202883 is the FDA 510(k) clearance for Sterile bone screw (PEEK ACL screw) by Osteonic Co., Ltd.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K202883 · Osteonic Co., Ltd. · Orthopedic device
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Nov 2020
Decision
58d
Days
Class 2
Risk

K202883 is an FDA 510(k) clearance for the Sterile bone screw (PEEK ACL screw). Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Osteonic Co., Ltd. (Guro-Gu, KR). The FDA issued a Cleared decision on November 25, 2020 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Osteonic Co., Ltd. devices

Submission Details

510(k) Number K202883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2020
Decision Date November 25, 2020
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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

Wise Company, Inc.
Sanglok Lee

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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

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