Cleared Traditional

K993166 - STRYKER BIOABSORBABLE INTERFERENCE SCRE...

K993166 is an FDA 510(k) clearance for STRYKER BIOABSORBABLE INTERFERENCE SCRE..., manufactured by Stryker Endoscopy. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K993166 · Stryker Endoscopy · Orthopedic device
Download Printable Device Report (PDF)
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Aug 2000
Decision
317d
Days
Class 2
Risk

K993166 is an FDA 510(k) clearance for the STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Stryker Endoscopy (Santa Clara, US). The FDA issued a Cleared decision on August 4, 2000 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Stryker Endoscopy devices

FDA 510(k) Submission Details - K993166

510(k) Number K993166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1999
Decision Date August 04, 2000
Days to Decision 317 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
195d slower than avg
Panel avg: 122d · This submission: 317d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K993166.
HOWMEDICA OSTEONICS SHOULDER SCREW
K002654 · Howmedica Osteonics Corp. · Sep 2000
BIOLOK SCREW
K002070 · Biocomposites, Ltd. · Aug 2000
2.4MM CORTEX SCREW, SELF-TAPPING
K002271 · Synthes (Usa) · Aug 2000
THE KALIX IMPLANT
K001231 · New Deal, S.A. · Jul 2000
BIOLOK SCREW
K993630 · Encore Orthopedics, Inc. · Apr 2000
ASNIS III CANNULATED SCREW SYSTEM
K000080 · Howmedica Osteonics Corp. · Apr 2000