Cleared Traditional

SPINE-FIX BIOMIMETIC BONE CEMENT (K043593) - FDA 510(k) Clearance

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

K043593 · Teknimed, S.A. · Orthopedic device
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Mar 2006
Decision
443d
Days
Class 2
Risk

K043593 is an FDA 510(k) clearance for the SPINE-FIX BIOMIMETIC BONE CEMENT. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Teknimed, S.A. (Round Rock, US). The FDA issued a Cleared decision on March 17, 2006 after a review of 443 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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 Teknimed, S.A. devices

Submission Details

510(k) Number K043593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2004
Decision Date March 17, 2006
Days to Decision 443 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
321d slower than avg
Panel avg: 122d · This submission: 443d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NDN Cement, Bone, Vertebroplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 - NDN Cement, Bone, Vertebroplasty

All 27
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K043593.
CONCORD Plus Radiopaque Bone Cement
K162618 · Globus Medical, Inc. · Jan 2017
Kyphon HV-R Bone Cement
K160983 · Medtronic, Inc. · Aug 2016
KYPH X HV-R BONE CEMENT
K093828 · Medtronic, Inc. · Aug 2010
VERTEFIX VERTEBROPLASTY PROCEDURE SET
K042691 · Cook, Inc. · Nov 2005
CONCORD Radiopaque Bone Cement
K042168 · Globus Medical, Inc. · Jan 2005