Cleared Traditional

K935321 - INNOVASIVE SUTURE BONE FASTENER WITH SUTURE (FDA 510(k) Clearance)

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

K935321 · Innovasive Devices, Inc. · Orthopedic device
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Oct 1994
Decision
349d
Days
Class 2
Risk

K935321 is an FDA 510(k) clearance for the INNOVASIVE SUTURE BONE FASTENER WITH SUTURE. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Innovasive Devices, Inc. (Hopkinton, US). The FDA issued a Cleared decision on October 19, 1994 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Innovasive Devices, Inc. devices

Submission Details

510(k) Number K935321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1993
Decision Date October 19, 1994
Days to Decision 349 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
227d slower than avg
Panel avg: 122d · This submission: 349d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDR Staple, 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 - JDR Staple, Fixation, Bone

All 230
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