Cleared Traditional

K970048 - SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS)

K970048 is an FDA 510(k) clearance for SYNTHES(USA)TITANIUM LOCKING PLATE SYST..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K970048 · Synthes (Usa) · Orthopedic device
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Aug 1997
Decision
207d
Days
Class 2
Risk

K970048 is an FDA 510(k) clearance for the SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS). Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on August 1, 1997 after a review of 207 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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

FDA 510(k) Submission Details - K970048

510(k) Number K970048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1997
Decision Date August 01, 1997
Days to Decision 207 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
85d slower than avg
Panel avg: 122d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 586
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K970048.
SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K971883 · Synthes (Usa) · Oct 1997
M-2 ANTERIOR PLATE SYSTEM
K972718 · Acromed Corp. · Oct 1997
TITANIUM SPINAL ROD SYSTEM
K970635 · Smith & Nephew, Inc., Orthopaedic Div. · Aug 1997
DUAL ROD ANTERIOR FIXATOR SYSTEM
K963780 · Sofamor Danek USA,Inc. · Jul 1997
ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM
K970955 · Acromed Corp. · Jun 1997
KANEDA SR ANTERIOR SPINAL SYSTEM
K971248 · Acromed Corp. · Jun 1997