Cleared Traditional

K931847 - BIO-PREP CEMENT RESTRICTOR

K931847 is an FDA 510(k) clearance for BIO-PREP CEMENT RESTRICTOR, manufactured by Biomedical Devices, Inc.. The device is a Class 2 Orthopedic device with product code LZN cleared through the Traditional 510(k) pathway after a 441-day FDA review.

K931847 · Biomedical Devices, Inc. · Orthopedic device
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Jun 1994
Decision
441d
Days
Class 2
Risk

K931847 is an FDA 510(k) clearance for the BIO-PREP CEMENT RESTRICTOR. Classified as Cement Obturator (product code LZN), Class II - Special Controls.

Submitted by Biomedical Devices, Inc. (Irvine, US). The FDA issued a Cleared decision on June 28, 1994 after a review of 441 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Biomedical Devices, Inc. devices

FDA 510(k) Submission Details - K931847

510(k) Number K931847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1993
Decision Date June 28, 1994
Days to Decision 441 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
319d slower than avg
Panel avg: 122d · This submission: 441d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZN Device Classification - Class 2, Special Controls

Product Code LZN Cement Obturator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - LZN Cement Obturator

All 26
Devices cleared under the same product code (LZN) and FDA review panel - the closest regulatory comparables to K931847.
IMPLEX CEMENT RESTRICTOR SYSTEM
K943378 · Implex Corp. · Sep 1994
ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR
K932595 · Johnson & Johnson Orthopaedics, Inc. · Sep 1994
P.F.C. CEMENT RESTRICTOR
K942060 · Johnson & Johnson Professionals, Inc. · Sep 1994
UNIVERSAL BONE CEMENT KIT
K931540 · Biodynamic Technologies, Inc. · Jan 1994
RESORABPLUG
K920118 · Sofamor Danek Mfg., Inc. · Feb 1993
CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL
K923909 · Orthomet, Inc. · Nov 1992