Cleared Traditional

BONE SCREW (K893203) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 65
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K893203.
HARPOON SUTURE ANCHOR
K926037 · Biomet, Inc. · May 1993
BONE STAPLE(S)
K904553 · Synthes (Usa) · Dec 1990
HTO COMPRESSING STAPLE
K895117 · Howmedica Corp. · May 1990
BONE STAPLING FIXATION SYS
K840566 · 3M Company · Nov 1984
ELLISON VITALLIUM FIXATION STAPLE SYS
K822943 · Howmedica Corp. · Oct 1982
COLBALT ALLOY ORTHOPAEDIC WIRE
K811500 · Osteonics Corp. · Jun 1981