Cleared Traditional

K984458 - DEPUY ACE SPIDER PLATE

K984458 is an FDA 510(k) clearance for DEPUY ACE SPIDER PLATE, manufactured by Depuy Ace Medical Co.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K984458 · Depuy Ace Medical Co. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
16d
Days
Class 2
Risk

K984458 is an FDA 510(k) clearance for the DEPUY ACE SPIDER PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Depuy Ace Medical Co. (El Segundo, US). The FDA issued a Cleared decision on December 31, 1998 after a review of 16 days - a notably fast clearance cycle.

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: 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 Depuy Ace Medical Co. devices

FDA 510(k) Submission Details - K984458

510(k) Number K984458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1998
Decision Date December 31, 1998
Days to Decision 16 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
106d faster than avg
Panel avg: 122d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, 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 - HRS Plate, Fixation, Bone

All 1075
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K984458.
KMI WRIST FUSION SYSTEM
K990094 · Kinetikos Medical, Inc. · Feb 1999
SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE
K983988 · Syntec Scientific Corp. · Jan 1999
SYNTHES PROXIMAL TIBIA PLATING SYSTEM
K983787 · Synthes (Usa) · Jan 1999
DEPUY ACE TIMAX META PLATE
K983853 · Depuy Ace Medical Co. · Dec 1998
PEDIATRIC CANNULATED OSTEOTOMY PLATES
K983967 · Biomet, Inc. · Dec 1998
COBRA EXTERNAL FIXATOR
K983881 · Orthopaedic Innovations, Inc. · Dec 1998