Cleared Traditional

K982222 - SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM

K982222 is an FDA 510(k) clearance for SYNTHES (USA) DISTAL FEMUR PLATE (DFP) ..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K982222 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
35d
Days
Class 2
Risk

K982222 is an FDA 510(k) clearance for the SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on July 29, 1998 after a review of 35 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K982222

510(k) Number K982222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1998
Decision Date July 29, 1998
Days to Decision 35 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
87d faster than avg
Panel avg: 122d · This submission: 35d
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 923
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K982222.
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
K982662 · DePuy Orthopaedics, Inc. · Oct 1998
ARTHROTEK INTERFERENCE SCREW
K982497 · Biomet, Inc. · Oct 1998
ENDO ABSORBABLE INTERFERENCE SCREW
K980457 · Endo Surgical Concepts, Inc. · Sep 1998
ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001
K981187 · Arthrex, Inc. · Jul 1998
CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM
K961320 · Buckman Co., Inc. · Jun 1998
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
K981670 · Depuy, Inc. · Jun 1998