Cleared Traditional

K953954 - PRELOADED SOFT TISSUE ANCHOR

K953954 is the FDA 510(k) clearance for PRELOADED SOFT TISSUE ANCHOR by Linvatec Corp.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K953954 · Linvatec Corp. · Orthopedic device
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Feb 1996
Decision
182d
Days
Class 2
Risk

K953954 is an FDA 510(k) clearance for the PRELOADED SOFT TISSUE ANCHOR. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on February 20, 1996 after a review of 182 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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. Standard predicate reliance. 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 Linvatec Corp. devices

Submission Details

510(k) Number K953954 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 22, 1995
Decision Date February 20, 1996
Days to Decision 182 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 122d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 412
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K953954.
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K953702 · Linvatec Corp. · Oct 1995
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K953264 · Wrightmedicaltechnologyinc · Oct 1995