Cleared Traditional

K243357 - CastleLoc Pectus Bar System

K243357 is the FDA 510(k) clearance for CastleLoc Pectus Bar System by L & K Biomed Co., Ltd.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K243357 · L & K Biomed Co., Ltd. · Orthopedic device
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Feb 2025
Decision
121d
Days
Class 2
Risk

K243357 is an FDA 510(k) clearance for the CastleLoc Pectus Bar System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by L & K Biomed Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on February 27, 2025 after a review of 121 days - within the typical 510(k) review window.

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 L & K Biomed Co., Ltd. devices

Submission Details

510(k) Number K243357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2024
Decision Date February 27, 2025
Days to Decision 121 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
1d faster than avg
Panel avg: 122d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 885
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K243357.
The OsteoCentric Bone Plate and Screw System
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EVOS Pelvic and Acetabular System
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A.L.P.S. Small Fragment Plating System
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Locking Plates and Screws Systems
K240958 · Hebei Ruihe Medical Devices Co., Ltd. · Feb 2025