Cleared Traditional

K931540 - UNIVERSAL BONE CEMENT KIT

K931540 is an FDA 510(k) clearance for UNIVERSAL BONE CEMENT KIT, manufactured by Biodynamic Technologies, Inc.. The device is a Class 2 Orthopedic device with product code LZN cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K931540 · Biodynamic Technologies, Inc. · Orthopedic device
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Jan 1994
Decision
304d
Days
Class 2
Risk

K931540 is an FDA 510(k) clearance for the UNIVERSAL BONE CEMENT KIT. Classified as Cement Obturator (product code LZN), Class II - Special Controls.

Submitted by Biodynamic Technologies, Inc. (Arlington, US). The FDA issued a Cleared decision on January 27, 1994 after a review of 304 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biodynamic Technologies, Inc. devices

FDA 510(k) Submission Details - K931540

510(k) Number K931540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1993
Decision Date January 27, 1994
Days to Decision 304 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
182d slower than avg
Panel avg: 122d · This submission: 304d
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 19
Devices cleared under the same product code (LZN) and FDA review panel - the closest regulatory comparables to K931540.
PFC CEMENT RESTRICTOR
K951934 · Johnson & Johnson Professionals, Inc. · May 1995
IMPLEX CEMENT RESTRICTOR SYSTEM
K943378 · Implex Corp. · Sep 1994
P.F.C. CEMENT RESTRICTOR
K942060 · Johnson & Johnson Professionals, Inc. · Sep 1994
CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL
K923909 · Orthomet, Inc. · Nov 1992
HIP FRACTURE STEM SYSTEM - FENESTRATION PLUG
K890326 · Howmedica Corp. · Feb 1989
SILASTIC INFLATABLE BONE PLUG H.P.
K853186 · Dow Corning Corp. Healthcare Industries Materials · Sep 1985