Cleared Traditional

K930009 - STRYKER 2S SPINAL SYSTEM

K930009 is the FDA 510(k) clearance for STRYKER 2S SPINAL SYSTEM by Stryker Corp.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 605-day FDA review.

K930009 · Stryker Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Sep 1994
Decision
605d
Days
Class 2
Risk

K930009 is an FDA 510(k) clearance for the STRYKER 2S SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Stryker Corp. (59 Route 17, US). The FDA issued a Cleared decision on September 1, 1994 after a review of 605 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 Stryker Corp. devices

Submission Details

510(k) Number K930009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1993
Decision Date September 01, 1994
Days to Decision 605 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
483d slower than avg
Panel avg: 122d · This submission: 605d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 271
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K930009.
TITANIUM MOSS MIAMI SPINAL SYSTEM
K955348 · Depuy, Inc. · Feb 1996
CD LIBERTY POSTERIOR SPINCAL SYSTEM
K951164 · Sofamor Danek USA,Inc. · Feb 1996
TITANIUM GDLH POSTERIOR SPINAL SYSTEM
K954645 · Sofamor Danek USA,Inc. · Jan 1996
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K933881 · Depuy, Inc. · Jul 1994
TI-FRAME
K934860 · Johnson & Johnson Professionals, Inc. · Jun 1994
TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON
K933205 · Danek Medical, Inc. · May 1994