Cleared Traditional

K231087 - Guided Surgery Kit

K231087 is an FDA 510(k) clearance for Guided Surgery Kit, manufactured by Implant Direct Sybron Manufacturing, LLC. The device is a Class 2 General Hospital device with product code DZI cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K231087 · Implant Direct Sybron Manufacturing, LLC · General Hospital
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Aug 2023
Decision
121d
Days
Class 2
Risk

K231087 is an FDA 510(k) clearance for the Guided Surgery Kit. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Implant Direct Sybron Manufacturing, LLC (Thousand Oaks, US). The FDA issued a Cleared decision on August 16, 2023 after a review of 121 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 872.4120 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Implant Direct Sybron Manufacturing, LLC devices

FDA 510(k) Submission Details - K231087

510(k) Number K231087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2023
Decision Date August 16, 2023
Days to Decision 121 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 129d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZI Device Classification - Class 2, Special Controls

Product Code DZI Drill, Bone, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
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 General Hospital devices follow this clearance model.

Regulatory Peers - DZI Drill, Bone, Powered

All 29
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K231087.
VarioSurg 4
K254163 · Nakanishi, Inc. · Dec 2025
MT-Bone
K242432 · Mectron S.P.A. · Aug 2024
Surgical Drive System (Model: ES70, ES90, E8)
K240340 · Guangdong Jinme Medical Technology Co., Ltd. · Jul 2024
TRAUS SUS20
K192561 · Saeshin Precision Co., Ltd. · Jul 2020
Surgical Drills
K200265 · Implant Direct Sybron Manufacturing, LLC · Jun 2020
Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip
K192033 · Bennett Jacoby, Dds, Ms, Inc. · Jun 2020