Cleared Traditional

K893203 - BONE SCREW

K893203 is an FDA 510(k) clearance for BONE SCREW, manufactured by Karlin Technology, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K893203 · Karlin Technology, Inc. · Orthopedic device
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Apr 1990
Decision
343d
Days
Class 2
Risk

K893203 is an FDA 510(k) clearance for the BONE SCREW. Classified as Staple, Fixation, Bone (product code JDR), 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 - K893203

510(k) Number K893203 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.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, 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 - JDR Staple, Fixation, Bone

All 149
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K893203.
BARBED SQUARE STAPLE
K903273 · Onyx Medical Corp. · Jul 1990
MITEK ANCHOR II
K902751 · Mitek Surgical Products, Inc. · Jul 1990
HTO COMPRESSING STAPLE
K895117 · Howmedica Corp. · May 1990
MITEK ANCHOR(TM)
K897155 · Mitek Surgical Products, Inc. · Apr 1990
MITEK ANCHOR
K892126 · Mitek Surgical Products, Inc. · Sep 1989
STAPLE FIXATION SYSTEM
K894929 · Concept, Inc. · Aug 1989