Cleared Special

K993510 - MODIFIED BMP TROCHANTERIC PLATES

K993510 is the FDA 510(k) clearance for MODIFIED BMP TROCHANTERIC PLATES by Biomet, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Special 510(k) pathway after a 29-day FDA review.

K993510 · Biomet, Inc. · Orthopedic device
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Nov 1999
Decision
29d
Days
Class 2
Risk

K993510 is an FDA 510(k) clearance for the MODIFIED BMP TROCHANTERIC 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 November 16, 1999 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biomet, Inc. devices

Submission Details

510(k) Number K993510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1999
Decision Date November 16, 1999
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 943
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K993510.
DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE
K993465 · Depuy, Inc. · Jan 2000
LACTOSORB TRAUMA PLATING SYSTEM
K992355 · Biomet, Inc. · Dec 1999
SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)
K993106 · Smith & Nephew, Inc. · Dec 1999
LORENZ SMALL FRAGMENT SYSTEM
K992961 · Walter Lorenz Surgical, Inc. · Nov 1999
LACTOSORB HAND SYSTEM
K991763 · Biomet, Inc. · Jul 1999
ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM
K990481 · Biodynamic Technologies, Inc. · Mar 1999