Cleared Traditional

K904243 - TSRH VARIABLE ANGLE SACRAL SCREW

K904243 is an FDA 510(k) clearance for TSRH VARIABLE ANGLE 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 495-day FDA review.

K904243 · Danek Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
495d
Days
Class 2
Risk

K904243 is an FDA 510(k) clearance for the TSRH VARIABLE ANGLE 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 January 22, 1992 after a review of 495 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Danek Medical, Inc. devices

FDA 510(k) Submission Details - K904243

510(k) Number K904243 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 14, 1990
Decision Date January 22, 1992
Days to Decision 495 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
373d slower than avg
Panel avg: 122d · This submission: 495d
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 K904243.
ISOLA(R) TRANSVERSE ROD DUAL CONNECTOR
K921090 · Acromed Corp. · Dec 1992
MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS
K912837 · Kirschner Medical Corp. · Aug 1992
CROSSLINK SYSTEM
K911663 · Synthes (Usa) · Mar 1992
LUQUE SEGMENTAL SPINAL INSTRUMENTATION
K913561 · Zimmer, Inc. · Jan 1992
RAY SACRAL FIXATION SYSTEM
K904520 · Danek Medical, Inc. · Oct 1991
CROSSLINK PLATE
K911307 · Danek Medical, Inc. · Oct 1991