Cleared Traditional

SILASTIC BONE PLUG H.P.(CEMENT RESTRICT) (K800898) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K800898 · Dow Corning Corp. Healthcare Industries Materials · Orthopedic device
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May 1980
Decision
14d
Days
Class 2
Risk

K800898 is an FDA 510(k) clearance for the SILASTIC BONE PLUG H.P.(CEMENT RESTRICT). Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Dow Corning Corp. Healthcare Industries Materials (Mchenry, US). The FDA issued a Cleared decision on May 2, 1980 after a review of 14 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 Dow Corning Corp. Healthcare Industries Materials devices

Submission Details

510(k) Number K800898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1980
Decision Date May 02, 1980
Days to Decision 14 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 122d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDS Nail, 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 - JDS Nail, Fixation, Bone

All 35
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K800898.
UNIVERSAL FEMORAL NAIL
K914371 · Synthes (Usa) · Feb 1992
UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL
K914453 · Synthes (Usa) · Feb 1992
HUMERAL LOCKING NAIL SYSTEM
K883882 · Howmedica Corp. · Jan 1989
FUSON BONE PLUG, RADIOPAQUE
K800142 · Zimmer, Inc. · Feb 1980
FEMORAL CEMENT RESTRICTOR
K800144 · Biomet, Inc. · Feb 1980
B.G. FLEXIBLE NAIL SYSTEM
K770130 · Howmedica Corp. · Jan 1977