Cleared Traditional

K972233 - STRYKER WEDGE INTERFERENCE SCREW SYSTEM

K972233 is an FDA 510(k) clearance for STRYKER WEDGE INTERFERENCE SCREW SYSTEM, 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 50-day FDA review.

K972233 · Stryker Endoscopy · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
50d
Days
Class 2
Risk

K972233 is an FDA 510(k) clearance for the STRYKER WEDGE 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 5, 1997 after a review of 50 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Endoscopy devices

FDA 510(k) Submission Details - K972233

510(k) Number K972233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1997
Decision Date August 05, 1997
Days to Decision 50 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
72d faster than avg
Panel avg: 122d · This submission: 50d
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 K972233.
SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II
K973586 · Spinal Concepts, Inc. · Nov 1997
DEPUY DUPONT ABSORBABLE SET SCREW
K972494 · Depuy, Inc. · Oct 1997
BTI CORTICAL BONE SCREWS
K972403 · Biodynamic Technologies, Inc. · Aug 1997
OSTEO CANNULATED SCREW SYSTEM
K971800 · Osteonics Corp. · Jul 1997
OSTEO COMPRESSION HIP SCREW SYSTEM
K971654 · Osteonics Corp. · Jul 1997
OSTEO SMALL AND MINI BONE SCREWS
K971778 · Osteonics Corp. · Jun 1997