Cleared Traditional

QUESTLOCK ACL FIXATOR (K954683) - FDA 510(k) Clearance

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

K954683 · Wrightmedicaltechnologyinc · Orthopedic device
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Apr 1996
Decision
195d
Days
Class 2
Risk

K954683 is an FDA 510(k) clearance for the QUESTLOCK ACL FIXATOR. 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 Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on April 23, 1996 after a review of 195 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K954683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1995
Decision Date April 23, 1996
Days to Decision 195 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 122d · This submission: 195d
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 300
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K954683.
QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM
K963200 · Wrightmedicaltechnologyinc · Oct 1996
ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM
K963217 · Wrightmedicaltechnologyinc · Oct 1996
STATAK SOFT TISSUE ATTACHMENT DEVICE
K962397 · Zimmer, Inc. · Aug 1996
FASTAK SUTURE ANCHOR
K960516 · Arthrex, Inc. · Apr 1996
QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM
K953264 · Wrightmedicaltechnologyinc · Oct 1995
ARTHREX SUTURE ANCHOR SCREW SYSTEM
K934327 · Arthrex, Inc. · Sep 1995