Cleared Traditional

K924034 - MINVASIVE SUTURE BONE FASTENER

K924034 is the FDA 510(k) clearance for MINVASIVE SUTURE BONE FASTENER by Innovasive Devices, Inc.. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 378-day FDA review.

K924034 · Innovasive Devices, Inc. · Orthopedic device
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Aug 1993
Decision
378d
Days
Class 2
Risk

K924034 is an FDA 510(k) clearance for the MINVASIVE SUTURE BONE FASTENER. 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 August 24, 1993 after a review of 378 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 K924034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1992
Decision Date August 24, 1993
Days to Decision 378 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
256d slower than avg
Panel avg: 122d · This submission: 378d
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 99
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K924034.
ACUFEX SURETAC
K931519 · Acufex Microsurgical, Inc. · Jun 1994
STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE
K926384 · Zimmer, Inc. · Nov 1993
ACUFEX SURETAC(R) PAC
K930538 · Acufex Microsurgical, Inc. · Sep 1993
ACUFEX(R) TAG(TM)
K911293 · Acufex Microsurgical, Inc. · Jul 1993
CONCEPT 4MM CANCELLOUS SCREW WITH EYELET
K924941 · Linvatec Corp. · Jun 1993
HARPOON SUTURE ANCHOR
K926037 · Biomet, Inc. · May 1993