Cleared Traditional

K983967 - PEDIATRIC CANNULATED OSTEOTOMY PLATES

K983967 is an FDA 510(k) clearance for PEDIATRIC CANNULATED OSTEOTOMY PLATES, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K983967 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
40d
Days
Class 2
Risk

K983967 is an FDA 510(k) clearance for the PEDIATRIC CANNULATED OSTEOTOMY PLATES. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 16, 1998 after a review of 40 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K983967

510(k) Number K983967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1998
Decision Date December 16, 1998
Days to Decision 40 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
82d faster than avg
Panel avg: 122d · This submission: 40d
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 1272
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K983967.
SYNTHES PROXIMAL TIBIA PLATING SYSTEM
K983787 · Synthes (Usa) · Jan 1999
DEPUY ACE SPIDER PLATE
K984458 · Depuy Ace Medical Co. · Dec 1998
DEPUY ACE TIMAX META PLATE
K983853 · Depuy Ace Medical Co. · Dec 1998
COBRA EXTERNAL FIXATOR
K983881 · Orthopaedic Innovations, Inc. · Dec 1998
HOFFMANN II MIAMI POST
K983419 · Howmedica Corp. · Nov 1998
HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM
K982531 · Howmedica Corp. · Oct 1998