Cleared Traditional

K902775 - KNIGHT SACRAL SCREW

K902775 is an FDA 510(k) clearance for KNIGHT SACRAL SCREW, manufactured by Danek Medical, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K902775 · Danek Medical, Inc. · Orthopedic device
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Dec 1990
Decision
168d
Days
Class 2
Risk

K902775 is an FDA 510(k) clearance for the KNIGHT SACRAL SCREW. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on December 10, 1990 after a review of 168 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Danek Medical, Inc. devices

FDA 510(k) Submission Details - K902775

510(k) Number K902775 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 25, 1990
Decision Date December 10, 1990
Days to Decision 168 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
46d slower than avg
Panel avg: 122d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 309
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K902775.
ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK
K905184 · Acromed Corp. · Feb 1991
ACROMED SACRAL SCREW
K903376 · Acromed Corp. · Dec 1990
TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS)
K901005 · Danek Medical, Inc. · Dec 1990
TSRH OFFSET AND SIDE-LOADING HOOKS
K903461 · Danek Medical, Inc. · Dec 1990
TSRH SACRAL L-CONNECTOR
K901587 · Danek Medical, Inc. · Nov 1990
MODULOCK POSTERIOR SPINAL FIXATION
K902397 · Zimmer, Inc. · Nov 1990