Cleared Traditional

K984320 - BIOABSORBABLE INTERFERENCE SCREWS

K984320 is an FDA 510(k) clearance for BIOABSORBABLE INTERFERENCE SCREWS, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K984320 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
56d
Days
Class 2
Risk

K984320 is an FDA 510(k) clearance for the BIOABSORBABLE INTERFERENCE SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Mansfield, US). The FDA issued a Cleared decision on January 28, 1999 after a review of 56 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 Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K984320

510(k) Number K984320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1998
Decision Date January 28, 1999
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
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 929
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K984320.
DRG MEDIUM SCREW SYSTEM
K990019 · Dolphin Medical Technologies, Inc. · Mar 1999
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K984209 · Biomet, Inc. · Feb 1999
SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS
K983592 · Sulzer Orthopedics, Inc. · Jan 1999
ODI ULTIMATE COMPRESSION HIP SCREW
K984331 · Orthopedic Designs, Inc. · Jan 1999
PHUSIS ABSORBABLE INTERFERENCE SCREW
K970829 · Tornier · Dec 1998
SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420
K983495 · Syntec Scientific Corp. · Dec 1998