Cleared Traditional

K952495 - ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM

K952495 is an FDA 510(k) clearance for ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM, manufactured by Orthopedic Systems, Inc.. The device is a Class 1 Orthopedic device with product code LXH cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K952495 · Orthopedic Systems, Inc. · Orthopedic device
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Jan 1996
Decision
237d
Days
Class 1
Risk

K952495 is an FDA 510(k) clearance for the ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM. Classified as Orthopedic Manual Surgical Instrument (product code LXH), Class I - General Controls.

Submitted by Orthopedic Systems, Inc. (Union City, US). The FDA issued a Cleared decision on January 22, 1996 after a review of 237 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - 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 Orthopedic Systems, Inc. devices

FDA 510(k) Submission Details - K952495

510(k) Number K952495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1995
Decision Date January 22, 1996
Days to Decision 237 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
115d slower than avg
Panel avg: 122d · This submission: 237d
Pathway characteristics
Predicate-based equivalence.

LXH Device Classification - Class 1, General Controls

Product Code LXH Orthopedic Manual Surgical Instrument
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LXH Orthopedic Manual Surgical Instrument

All 22
Devices cleared under the same product code (LXH) and FDA review panel - the closest regulatory comparables to K952495.
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STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH
K941605 · Stryker Corp. · Aug 1994