Cleared Traditional

K991763 - LACTOSORB HAND SYSTEM

K991763 is the FDA 510(k) clearance for LACTOSORB HAND SYSTEM by Biomet, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K991763 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
67d
Days
Class 2
Risk

K991763 is an FDA 510(k) clearance for the LACTOSORB HAND SYSTEM. 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 July 30, 1999 after a review of 67 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

Submission Details

510(k) Number K991763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1999
Decision Date July 30, 1999
Days to Decision 67 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
55d faster than avg
Panel avg: 122d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K991763.
SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)
K993106 · Smith & Nephew, Inc. · Dec 1999
MODIFIED BMP TROCHANTERIC PLATES
K993510 · Biomet, Inc. · Nov 1999
LORENZ SMALL FRAGMENT SYSTEM
K992961 · Walter Lorenz Surgical, Inc. · Nov 1999
ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM
K990481 · Biodynamic Technologies, Inc. · Mar 1999
SYNTHES PROXIMAL TIBIA PLATING SYSTEM
K983787 · Synthes (Usa) · Jan 1999
PEDIATRIC CANNULATED OSTEOTOMY PLATES
K983967 · Biomet, Inc. · Dec 1998