Cleared Traditional

K893201 - BONE PLATE

K893201 is an FDA 510(k) clearance for BONE PLATE, manufactured by Karlin Technology, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K893201 · Karlin Technology, Inc. · Orthopedic device
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Apr 1990
Decision
343d
Days
Class 2
Risk

K893201 is an FDA 510(k) clearance for the BONE PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Karlin Technology, Inc. (Torrance, US). The FDA issued a Cleared decision on April 4, 1990 after a review of 343 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: 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 Karlin Technology, Inc. devices

FDA 510(k) Submission Details - K893201

510(k) Number K893201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1989
Decision Date April 04, 1990
Days to Decision 343 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 122d · This submission: 343d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

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 1053
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K893201.
ACE RECONSTRUCTIVE PLATE
K905595 · Ace Medical Co. · Mar 1991
BROAD SELF-COMPRESSING PLATE
K905355 · O'Tec Corp. · Jan 1991
BROAD SELF-COMPRESSING PLATE
K903252 · Onyx Medical Corp. · Aug 1990
INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM
K892228 · Intermedics Orthopedics · Oct 1989
DUPONT DISTAL HUMERAL NAIL
K890939 · Howmedica Corp. · May 1989
ACUFEX CANNULATED SCREWS, WASHERS, BONE PLATES
K890641 · Acufex Microsurgical, Inc. · Feb 1989