Cleared Traditional

K884688 - MODULAR SPINAL FIXATION & LOCKING HOOK ...

K884688 is the FDA 510(k) clearance for MODULAR SPINAL FIXATION & LOCKING HOOK ... by Synthes (Usa). It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K884688 · Synthes (Usa) · Orthopedic device
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Feb 1989
Decision
108d
Days
Class 2
Risk

K884688 is an FDA 510(k) clearance for the MODULAR SPINAL FIXATION & LOCKING HOOK SPINAL ROD. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on February 24, 1989 after a review of 108 days - within the typical 510(k) review window.

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 Synthes (Usa) devices

Submission Details

510(k) Number K884688 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 08, 1988
Decision Date February 24, 1989
Days to Decision 108 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
14d faster than avg
Panel avg: 122d · This submission: 108d
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 270
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K884688.
ACROMED ILIAC SCREW
K884161 · Buckman Co., Inc. · May 1989
ACROMED SPINAL ROD AND SPINAL HOOKS
K884163 · Buckman Co., Inc. · Apr 1989
THE C-S DISTRACTION ROD ASSEMBLY
K890187 · Orthopedic Systems, Inc. · Apr 1989
LEA PLAZA SPINAL FRAME SYSTEM
K884585 · Orthomet, Inc. · Jan 1989
ROGOZINSKI SPINAL SYSTEM
K884263 · Richards Medical Co., Inc. · Dec 1988
ACROMED CROSS ROD CONNECTOR
K874882 · Acromed Corp. · Feb 1988